Advocating for yourself while living with moderate-to-severe atopic dermatitis

2022-11-09T09:31:00

(BPT) – Sponsored by Pfizer

Living with moderate-to-severe atopic dermatitis (AD) – also known as eczema – can be challenging.[1] In addition to having the physical burden that includes flare-ups of red, itchy, painful skin, there is also the emotional and social impact.[2],[3],[4],[5] Those living with eczema aren’t alone – in fact AD is one of the most common chronic inflammatory skin diseases, impacting people of all genders, races, ethnicities and ages.[2],[6],[7],[8] If you’re living with eczema, a proactive approach and self-advocacy can make a big difference in feeling empowered versus overpowered by your moderate-to-severe AD. Here are six ways to help you feel more confident and in control:

1. Take charge of living with eczema

You know your body best – if you think you have eczema or it may be worsening, speak up and consult with your doctor. Talk with your health care team about steps you can take to try to identify or eliminate triggers and irritants for your moderate-to-severe AD.[2],[9] Consider keeping a log of your symptoms and bringing this with you to doctor’s appointments to help understand what might be aggravating your skin. Openly sharing your concerns with your doctor may also help you to identify a treatment plan and options that might be helpful for you. A few simple steps now may make a big difference in how you look and feel in the future.

2. Establish a health care support team

Having a health care team you trust and feel comfortable with is critical. You should be able to speak candidly with your doctor and feel like you are being heard. If this is lacking, consider finding a different doctor, or getting a second opinion – many medical professionals even encourage this. Don’t hold back when it comes to finding the right fit for you.

3. Make the most of appointments

Whether in person or virtually, each appointment you have is an opportunity to see your physician and share the status of your eczema symptoms. But it’s also an opportunity for you to ask questions about your eczema. Consider writing your concerns and questions down ahead of time and bringing the list to the appointment to ensure you don’t forget anything and nothing is overlooked. You may also want to capture pictures of the eczema on your skin to share with them. This preparation can help ensure you make the most of the time you may have with your doctor during the visit.

4. Understand your insurance process

Health insurance policies vary greatly. It’s important to understand deductibles, copays and coverage before proceeding with any appointments or treatments, so you can plan accordingly. Call your health insurance provider to review the process and what you can expect, including prescription coverage.

5. Know you are not alone

Having moderate-to-severe AD can feel isolating but understand that you are not alone.[10] Try to connect with others who are living with or caring for someone with the disease through support networks, advocacy groups or on social media. It may help to share your own experience with others.

6. Research and explore treatment options

Although there is no cure for eczema, there are different treatment options available depending on various factors, such as age and eczema severity.[11],[12] Current therapeutic approaches include applying over-the-counter moisturizers and emollients, or prescription topical, oral and injectable medications, and phototherapy.[12] One option may be CIBINQO (abrocitinib) – a prescription medicine to treat adults with moderate-to-severe eczema (atopic dermatitis) that did not respond to other treatment and is not well controlled with prescription medicines, including biologics, or when they cannot be tolerated.[13] Learn more at www.CIBINQO.com.

If you’ve had success with CIBINQO, consider sharing your story to help inspire others at www.CIBINQO.com/share-your-experience. It can feel great to make a positive impact for others, especially those who may be struggling.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR CIBINQO

CIBINQO may cause serious side effects, including:

Serious infections. CIBINQO can lower your immune system’s ability to fight infections. Do not start CIBINQO if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body, have occurred in people taking CIBINQO or other similar medicines. Some people have died from these infections. Your risk of developing shingles may increase while taking CIBINQO.

Your healthcare provider should test you for TB before treatment with CIBINQO and monitor you closely for signs and symptoms of TB infection during treatment.

Before and after starting CIBINQO, tell your doctor right away if you have an infection, are being treated for one, or have symptoms of an infection, including:

  • fever, sweating, or chills
  • muscle aches
  • cough or shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinating more often than usual
  • feeling very tired

CIBINQO can make you more likely to get infections or worsen infections you have.

There is an increased risk of death in people 50 years and older who have at least one heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK) inhibitor (such as CIBINQO).

Cancer and immune system problems. CIBINQO may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People, especially current or past smokers, have a higher risk of certain cancers, including lymphoma and lung cancers, while taking a JAK inhibitor. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment. Limit the amount of time you spend in sunlight and avoid using tanning beds or sunlamps. When in the sun, wear protective clothing and use SPF 30+ sunscreen. This is especially important if you have very fair skin or a family history of skin cancer. Tell your healthcare provider if you have ever had any type of cancer.

There is an increased risk of major cardiovascular (CV) events such as heart attack, stroke or death in people 50 years and older who have at least one heart disease (CV) risk factor and are taking a JAK inhibitor, especially for current or past smokers.

Some people taking CIBINQO have had major cardiovascular events.

Get emergency help right away if you develop any symptoms of a heart attack or stroke while taking CIBINQO, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • weakness in one part or on one side of your body
  • slurred speech
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking CIBINQO. This may be life-threatening. Blood clots in the veins of the legs and lungs have happened more often in people 50 years and older, with at least one heart disease (CV) risk factor, taking a JAK inhibitor. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past.

Get medical help right away if you have any signs and symptoms of blood clots including swelling, pain, or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing.

Changes in certain laboratory test results. Your doctor should do blood tests before and during treatment with CIBINQO to check your lymphocyte, neutrophil, red blood cell, and platelet counts. You should not take CIBINQO if these counts are too low. Your healthcare provider may stop treatment for a period of time if there are changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your doctor should do blood tests about 4 weeks after you start treatment and 4 weeks after any increase in dose to check blood cell counts and as often as needed for other laboratory tests.

During the first 3 months of treatment with CIBINQO, do not take medicines that prevent blood clots except low-dose aspirin (≤81 mg daily), if prescribed.

Before taking CIBINQO, tell your healthcare provider if you:

  • have an infection, are being treated for one, or have one that won’t go away or keeps returning
  • have diabetes, chronic lung disease, HIV, or a weak immune system
  • have TB or have been in close contact with someone with TB
  • have had shingles (herpes zoster)
  • have had hepatitis B or hepatitis C
  • live, have lived, or traveled to certain areas (such as Ohio & Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or worsen when taking CIBINQO. Ask your healthcare provider if you’re unsure if you have lived in an area where these infections are common
  • have had any type of cancer
  • have had blood clots in the veins of your legs or lungs
  • are a current or past smoker
  • have had a heart attack, other heart problems, or stroke
  • have kidney or liver problems
  • have abnormal blood tests (low platelet count or white blood cell count)
  • have any eye problems, including cataracts or retinal detachment
  • have recently received or are scheduled to receive any vaccinations. People who take CIBINQO should not receive live vaccines
  • are or plan to become pregnant. It is not known if CIBINQO will harm your unborn baby. Pfizer has a Pregnancy Exposure Registry for pregnant women who take CIBINQO to check your health and the health of your baby. If you are pregnant or become pregnant while taking CIBINQO, ask your healthcare provider how you can join this pregnancy registry or call 1-877-311-3770 to enroll
  • are breastfeeding or plan to breastfeed. It is not known if CIBINQO passes into your breast milk. You should not take CIBINQO while breastfeeding
  • are taking other medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CIBINQO and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take aspirin or any antiplatelet therapies. Ask your healthcare provider if you are unsure

The most common side effects of CIBINQO include common cold, nausea, headache, herpes simplex including cold sores, increased blood level of creatinine phosphokinase, dizziness, urinary tract infection, tiredness, acne, vomiting, mouth and throat pain, flu, stomach flu, bacterial skin infection, high blood pressure, allergic skin rash to something you contacted, stomach pain, shingles, and low platelet count.

CIBINQO may cause fertility problems in females, which may affect the ability of females to get pregnant. Talk to your healthcare provider if you have concerns about fertility.

Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people treated with CIBINQO. Call your healthcare provider right away if you have any sudden changes in your vision.

These are not all of the possible side effects of CIBINQO.

What is CIBINQO (si-BINK-oh)?
CIBINQO (abrocitinib) is a prescription medicine to treat adults with moderate-to-severe eczema (atopic dermatitis) that did not respond to other treatment and is not well controlled with prescription medicines, including biologics, or when they cannot be tolerated.

It is not known if CIBINQO is safe and effective in children.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

CIBINQO is available in 50 mg, 100 mg, and 200 mg pills.

Please click for full Prescribing Information, including BOXED WARNING, and Medication Guide or visit CIBINQO.com

This article is sponsored by Pfizer Inc.

PP-CIB-USA-0235

###


[1] Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis.2007;18(2):82-91.

[2] Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.

[3] Lifschitz C. The impact of atopic dermatitis on quality of life. Ann Nutr Metab. 2015;66(suppl 1):24-40.

[4] Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol. 2006;118(1):226-232.

[5] Anderson RT, Rajagopalan R. Effects of allergic dermatosis on health-related quality of life. Curr Allergy Asthma Rep. 2001;1:309-315.

[6] Kaufman BP, Guttman-Yassky E, Alexis AF. Atopic dermatitis in diverse racial and ethnic groups-Variations in epidemiology, genetics, clinical presentation and treatment. Exp Dermatol. 2018;27:340-357.

[7] Atar-Snir V. Gender and Dermatology. In: Tur E., Maibach H. (eds). Atopic Dermatitis. Springer. 2018;243-248.

[8] Akdis CA, Akdis M, Bieber T, et al. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL consensus report. J Allergy Clin Immunol. 2006;118:115-169.

[9] Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015;32(6):409-420.

[10] Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992

[11] Ellis C, Luger T, Abeck D, et al. International consensus conference on atopic dermatitis II (ICCAD II*): clinical update and current treatment strategies. Br J Dermatol. 2003;148(Suppl. 63):3-10.

[12] Boguniewicz M, Fonacier L, Guttman-Yassky E, Ong PY, Silverberg J, Farrar JR. Atopic dermatitis yardstick: practical recommendations for an evolving therapeutic landscape. Ann Allergy Asthma Immunol. 2018;120(1):10-22.

[13] CIBINQO (abrocitinib). Full Prescribing Information. January 2022.

Reaching personal goals: Partnering with a doctor to help manage a chronic inflammatory condition

2022-11-09T06:01:00

(BPT) – Content sponsored and provided by Pfizer. Jason partnered with Pfizer to share his experience living with moderate to severe ulcerative colitis (UC).

When Jason retired from his sales job in California, he looked forward to his personal goal of staying active in the next stage of his life. He enjoyed traveling, going on cruises with his girlfriend and outdoor activities like biking and playing racquetball with friends. However, his plans changed when he was diagnosed with a chronic inflammatory condition after his first colonoscopy.

Following the colonoscopy, Jason’s doctor referred him to a gastroenterologist for further testing. He was diagnosed with moderate to severe ulcerative colitis (UC), a chronic inflammatory disease of the large intestine (also called the colon) that affects the lining and causes sores or ulcers to form. Medicines can help manage UC symptoms, but do not cure UC.[i]

Having never heard of UC before his diagnosis, Jason began reading online about the disease and prescription treatment options. Over time, Jason began to experience recurring symptoms such as using the restroom up to 20 times a day. He was dealing with his UC symptoms and prioritizing being close to a bathroom.

“My UC diagnosis really began to affect me,” he says. “I felt like my symptoms were out of my control.”

Jason began working with his gastroenterologist on a treatment plan to help manage his symptoms of moderate to severe UC. He tried several medications, including a tumor necrosis factor (TNF) blocker that eventually stopped working well enough to help manage his UC symptoms. He continued to experience UC symptoms.

At that point, Jason saw an advertisement for XELJANZ® (tofacitinib), an oral medication for adults with moderate to severe UC who have used 1 or more medicines called TNF blockers that did not work well or could not be tolerated. He decided to speak with his gastroenterologist about whether XELJANZ could be a treatment option for him.

Jason’s gastroenterologist reviewed the benefits and possible serious side effects of XELJANZ with him and explained that it has a BOXED WARNING. They also discussed the type of monitoring and lab work that would be needed before and during treatment.

XELJANZ or XELJANZ XR can cause serious side effects and can lower your ability to fight infections; don’t start XELJANZ if you have an infection. Before and during treatment, your doctor should check for infections like tuberculosis, and do blood tests. Serious, sometimes fatal infections, cancers including lymphoma, and lung cancer, blood clots and serious heart-related events have happened. People 50 or older with heart disease risk factors had an increased risk of death. Tell your doctor if you had a heart attack, other heart problems, stroke or a history of blood clots.

Read more Important Safety Information and Indication below.

After Jason was prescribed XELJANZ, he called XELSOURCE, which helped him learn about the potential options to save on his prescription costs depending on his eligibility. “The XELSOURCE representatives have always been very helpful,” he says. “I appreciate being able to speak to someone on the phone about potential assistance for paying for my treatment.”

At his one-month follow-up appointment, Jason was happy to share with his gastroenterologist that he had experienced a reduction in his UC symptoms, including fewer bowel movements a day, since starting XELJANZ. He appreciates that XELJANZ is a pill and uses a 7-day pill box to keep track of his medication and remind himself to take XELJANZ every day as prescribed.

“I look forward to going out and doing the activities I love,” Jason said.

Through open communication and partnering with his doctor to find a treatment plan that works for him, Jason has been able to manage his UC symptoms and looks forward to staying active.

“I want to tell those newly diagnosed with moderate to severe UC that it’s important to speak up about their symptoms and have open and honest conversations with their doctor about their disease management plan if something isn’t working well for them.”

To learn more about XELJANZ, visit XELJANZ.com/UC.

IMPORTANT SAFETY INFORMATION AND INDICATION

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.

Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have symptoms of an infection, including:

  • fever, sweating, or chills
  • cough
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • burning when you urinate
  • urinating more often than normal
  • muscle aches
  • shortness of breath
  • weight loss
  • diarrhea or stomach pain
  • feeling very tired

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.

Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with ulcerative colitis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune system problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Are a current or past smoker
  • Have had any type of cancer
  • Have had a heart attack, other heart problems or stroke
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • ixekizumab (Taltz®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

What are other possible side effects of XELJANZ/XELJANZ XR?

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in people with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.


[i] Crohn’s & Colitis Foundation. What is Ulcerative Colitis? https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/overview

PP-XUC-USA-2028 August 2022

National Family Caregivers Month: The Impact of OFF Time for People With Parkinson’s Disease and Their Care Partners

2022-11-07T07:01:00

(BPT) – This article was sponsored and developed by Neurocrine Biosciences, Inc.

Approximately 43.5 million caregivers have provided unpaid care to an adult or child in the last 12 months. With November being National Family Caregivers Month, it’s a time to recognize care partners and celebrate the contributions that care partners make in supporting a loved one who may also be managing a health condition.

Jim and Hettie have been married for over 50 years and enjoy doing a variety of activities together, such as involvement in church activities, doing projects around the house, and Jim’s favorite hobby—bass fishing. When Jim, a veteran and retired accountant, began experiencing tremors in 2007 and noticed that his handwriting was getting progressively worse, he went to his doctor for help. Jim’s doctor told him that nothing could be done at the time. In 2012, Jim went to a neurologist for a second opinion and was diagnosed with Parkinson’s disease (PD).

PD, a chronic, progressive neurological and movement disorder, affects approximately 1 million people in the U.S. and 10 million people worldwide. Symptoms generally develop slowly over years. The progression of symptoms is unique to each individual. People with PD may experience tremors, slowness of movement, limb rigidity or stiffness, and gait or balance problems. While there is no cure for PD, medication can help improve daily symptoms.

After receiving his PD diagnosis, Hettie worked to help Jim adapt to his PD symptoms so that he could continue doing the things he loves. As Jim’s wife and care partner, Hettie keeps a log of Jim’s symptoms based on her observations, attends doctors’ appointments, and supports Jim in every way she can. Together, Jim and Hettie manage a PD support group and enjoy getting to know group members on a personal level. When Jim started to have challenges backing the couple’s boat down ramps to access the lake, putting his beloved pastime of fishing at risk, Hettie suggested they find a lake house to make Jim’s passion more accessible. The two found a small fixer-upper and have spent the past six years working side by side to improve the house and travel to it several times each week.

After Jim’s diagnosis, he began taking levodopa/carbidopa to treat his PD. Nearly nine years after being diagnosed in 2012, Jim began experiencing OFF time—a period of time between regular doses when medication “wears off” and symptoms return. He felt extremely sluggish in the mornings and noticed that his tremors would return after a long day, especially when he was overly fatigued. Like many people with PD and their care partners, Jim and Hettie weren’t familiar with OFF time—until they mentioned Jim’s symptoms to his doctor. A recent survey showed that 86 percent of people with PD experience OFF time, and most people with PD and their care partners say OFF time has a significant impact on their daily activities.

To help manage Jim’s OFF time symptoms, his doctor prescribed ONGENTYS® (opicapone) capsules, a prescription medicine used with levodopa/carbidopa in people with PD who are having OFF episodes. It is not known if ONGENTYS is safe and effective in children. The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

Please see full Important Safety Information below and Prescribing Information.

Hettie saw improvements in Jim’s symptoms after taking ONGENTYS. “With less OFF time, the spark is back in the man I married 54 years ago,” said Hettie. Jim also notices improvement and gets up and moves at a quicker pace each morning since taking ONGENTYS.

By sharing their story during National Family Caregivers Month, Jim and Hettie hope their personal journey encourages people with PD to share their experiences or concerns regarding symptoms with their loved ones and to speak with a healthcare provider about treatment options. They also remind people that each person has a different PD experience, and treatment varies from one person to another, which is why it is important to speak with a healthcare professional to determine the appropriate treatment approach.

To learn more about ONGENTYS, talk to your doctor or visit ongentys.com for more safety information.

See Important Safety Information Below

IMPORTANT INFORMATION

Approved Use

ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson’s disease (PD) who are having “OFF” episodes.

It is not known if ONGENTYS is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take ONGENTYS if you:

  • take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor.
  • have a tumor that secretes hormones known as catecholamines.

Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:

  • have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help you sleep or that makes you feel sleepy.
  • have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping.
  • have a history of uncontrolled sudden movements (dyskinesia).
  • have had hallucinations or psychosis.
  • have liver or kidney problems.
  • are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).

ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.

What should I avoid while taking ONGENTYS?

  • Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.

What are the possible side effects of ONGENTYS?

ONGENTYS may cause serious side effects, including:

  • Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson’s disease, without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while taking ONGENTYS are higher if you take other medicines that cause drowsiness.
  • Low blood pressure or dizziness, light headedness, or fainting.
  • Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often.
  • Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior.
  • Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.

The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.

These are not all of the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see ONGENTYS full Product Information.

This article was sponsored and developed by Neurocrine Biosciences, Inc. Jim and Hettie were compensated by Neurocrine Biosciences, Inc. to share their story.

©2022 Neurocrine Biosciences, Inc. All Rights Reserved. CP-OPC-US-0658 11/2022

Setting goals: How to manage a chronic inflammatory disease

2022-11-07T06:01:00

(BPT) – Content sponsored and provided by Pfizer. Ashley partnered with Pfizer to share her experience living with moderate to severe rheumatoid arthritis (RA).

Growing up, Ashley was active, played sports, and exercised regularly. So, when she began feeling joint pain, she attributed it to typical sports injuries or soreness. However, as time passed, she was concerned about the ongoing joint pain and swelling she was experiencing.

After discussing her symptoms with her aunt who was a nurse, Ashley sought help from a rheumatologist. Following multiple tests and exams, her rheumatologist diagnosed Ashley with moderate to severe rheumatoid arthritis (RA), a chronic inflammatory disease of the joints.

At first, it was difficult for Ashley to understand the permanence of her RA diagnosis and how it would impact her. “I don’t think I initially grasped the fact that I would be navigating this disease for the rest of my life,” says Ashley. As she processed her diagnosis, she continued with her usual activities, supplemented by physical therapy sessions when necessary.

However, as Ashley’s symptoms continued to progress she realized that she needed to re-prioritize her disease management and self-care. Working with her doctor, she became more aware of setting realistic exercise goals and finding activities that are more manageable with her RA.

When Ashley met Mike, her now-husband, she opened up to him about her RA on their first date. “I felt like it was important to be open about my RA with Mike because when you live with a chronic illness, it doesn’t just impact you. It impacts your significant other, your family members, and friends,” says Ashley.

“If you would have asked me what RA was before I met Ashley, I would have had no idea. Ashley was very upfront and honest about the challenges that she deals with, and over time I got to see firsthand how RA impacted her,” says Mike.

Throughout their marriage and Ashley’s journey with RA, Mike has been supportive of Ashley’s disease management goals and treatment plan. “He’s given me so much confidence to try different things that I would have never tried before, like traveling solo,” says Ashley. “He also has even given me the confidence to approach my doctor to find a treatment plan that works for me.”

During the course of her journey, Ashley has gone through a lot of trial and error with different types of prescription treatment plans for her RA. She tried multiple tumor necrosis factor (TNF) blockers, but these medicines did not work well enough for Ashley. As a result, she did some research online and read about XELJANZ® (tofacitinib), an oral medication for moderately to severely active rheumatoid arthritis when one or more medicines called TNF blockers have been used and did not work well or wasn’t tolerated. XELJANZ appealed to Ashley and she liked that it was an oral option. She brought it up with her rheumatologist after getting encouragement from her husband.

Ashley’s rheumatologist reviewed the benefits and possible serious side effects of XELJANZ with her. They also discussed the type of laboratory monitoring that would be needed before and during treatment. Her rheumatologist also explained that XELJANZ has a BOXED WARNING.

XELJANZ can cause serious side effects and can lower your ability to fight infections; don’t start XELJANZ if you have an infection. Before and during treatment, your doctor should check for infections like tuberculosis (TB), and do blood tests. Serious, sometimes fatal infections, cancers including lymphoma, and lung cancer, blood clots and serious heart-related events have happened. People 50 or older with heart disease risk factors had an increased risk of death. Tell your doctor if you had a heart attack, other heart problems, stroke, or a history of blood clots.

Read more Important Safety Information and Indication below.

After starting XELJANZ, Ashley noticed that she was experiencing less joint pain, swelling, and stiffness, and was feeling less fatigued. Ashley was also able to partake in some of the activities that she enjoyed before she was diagnosed with RA, such as hiking and bird watching.

What is Ashley’s advice for others living with RA?

“I always tell people to focus on what you can do instead of dwelling on what you can’t. Focus on the good things in your life because RA doesn’t define you. It’s a part of who you are, but it’s not all of who you are, and it doesn’t mean that you can’t have a productive, fulfilling, and happy life.”

To learn more about XELJANZ, visit XELJANZ.com/RA.

IMPORTANT SAFETY INFORMATION AND INDICATION

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.

Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have symptoms of an infection, including:

  • fever, sweating, or chills
  • cough
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • burning when you urinate
  • urinating more often than normal
  • muscle aches
  • shortness of breath
  • weight loss
  • diarrhea or stomach pain
  • feeling very tired

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.

Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with ulcerative colitis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune system problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Are a current or past smoker
  • Have had any type of cancer
  • Have had a heart attack, other heart problems or stroke
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • ixekizumab (Taltz®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

What are other possible side effects of XELJANZ/XELJANZ XR?

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in people with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular course juvenile arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
  • Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated.
  • Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have used, and did not work well or cannot be tolerated
  • Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

August 2022; PP-XEL-USA-7762

Four safety tips to help prepare your home for storms

2022-11-04T16:25:07

(BPT) – Natural disasters such as hurricanes, tornadoes, floods and snowstorms can occur at any time, so preparing ahead is key. However, a study by the Federal Emergency Management Agency found that only 44% of Americans are prepared for an unexpected natural disaster.

“Unfortunately, severe weather can occur throughout the year, so it is important to always be prepared,” said Ashley Gocken, a home safety expert with First Alert residential fire safety company, now part of Resideo Technologies, Inc. “Implementing new safety measures or strengthening the ones that you and your family have in place can help save yourself from unnecessary stress should an emergency arise.”

Follow these home safety tips to help ensure your family is prepared during storm season:

1) Equip for emergencies. Being prepared for inclement weather includes having an emergency kit ready. In addition to necessities such as a first aid kit, flashlight, water and medical supplies, make sure your safety kit includes a multi-tool, portable phone charger, fire extinguisher, carbon monoxide (CO) alarm, batteries, blankets and non-perishable food.

2) Know about CO. An invisible and odorless gas, carbon monoxide (CO) is the leading cause of accidental poisoning in the U.S., leading to more than 430 deaths each year, according to the Centers for Disease Control and Prevention. CO incidents can spike during storm season, due to the misuse of portable generators, stoves or grills as alternative heating sources during power outages.

In the case of a power outage, run generators in a well-ventilated, outdoor area to avoid CO build up in your home. Don’t operate them in the garage, even if you intend to keep the garage door open and be sure to keep it at least 20 feet away from any door, window or vent opening for extra safety precautions.

3) Install home safety tools. Because CO is impossible to detect without an alarm — and its symptoms like headache, nausea, dizziness, weakness and vomiting can easily be confused with the common cold — proper alarm placement, regular maintenance and alarm replacement are essential parts of your home safety plan. According to guidelines from the National Fire Protection Association, carbon monoxide and smoke alarms should be installed in or near every sleeping area and on every level of the home, including the basement. Equip your home with 10-year alarms or alarms with battery backup for protection during power outages. The First Alert Carbon Monoxide Plug-In Alarm with Battery Backup alerts residents to dangerous CO levels and, thanks to its battery backup, allows for continuous monitoring during a power outage.

For ultimate protection against the threats of smoke, fire and CO, install combination alarms such as the First Alert 10-Year Sealed Battery Smoke and CO Alarm to eliminate the need to replace batteries for a decade. Make sure alarms are installed at least 15 feet away from CO sources to reduce the chance of false alarms, but if one does sound, leave the home immediately and call 911. Be sure to test all alarms regularly, and for those without a 10-year battery, replace batteries at least every six months.

4) Safely store valuables. In case of an emergency, make sure important documents such as birth certificates, passports and insurance papers are stored in waterproof or fire-resistant safes or security chests, and create password-protected digital copies for preservation. Move valuables, including family heirlooms and prized possessions, to higher levels of the home or to the same safes for maximum security.

“Putting the proper protections in place can better enable families to be well-prepared when a severe storm arises, and all year round,” said Gocken.

For more information, visit www.firstalert.com.

World champion skier Lindsey Vonn on insomnia and scoring better sleep

2022-11-04T12:01:00

(BPT) – Lindsey Vonn has been tackling challenges all her life as a professional skier. However, one of her biggest challenges didn’t happen on her skis, but rather, in her own bed. A knee injury took her off the slopes to recoup in 2013. Around this time, she began having trouble falling and staying sleep, also known as insomnia, and even after recovering, she couldn’t shake it off. When she officially retired from the sport in 2019, her sleep problems only intensified.

She is not alone. More than 25 million Americans suffer from insomnia every year and experience firsthand the toll that it can take on their nights and days.[i], [ii] For Lindsey, not sleeping at night meant that she couldn’t be her best self during the day as an entrepreneur, author, philanthropist and investor.

Lindsey’s journey with QUVIVIQ® (daridorexant) CIV

After years of trying out various sleep hygiene practices, common over-the-counter supplements and even prescription sleep medicines, Lindsey still struggled with her sleep. She decided to talk to her doctor about available treatment options, and to understand the benefits and risks of each. Based on her needs and preferences, once-nightly QUVIVIQ was the best option for her — because in clinical studies QUVIVIQ has been shown to help adults with insomnia fall asleep faster and stay asleep longer with improvements measured at one month and which continued over a period of three months.

QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).[iii] As an athlete, Lindsey is incredibly mindful of what she puts in her body, which is why she talked to her doctor about the risks and benefits of treatment options to find the best one for her. Lindsey’s doctor told her that QUVIVIQ may cause headache or sleepiness during the day and to be cautious about driving or doing other activities until she feels fully awake. She feels good about taking QUVIVIQ because of its safety profile and because clinical studies show a lack of withdrawal symptoms after stopping usage, which suggests no physical dependence. QUVIVIQ is a federally controlled substance because it can be abused or cause dependence.

“I didn’t just decide to be a championship skier. I worked at it, and that’s how I approach my sleep,” said Lindsey. “It’s a journey, which is why I talked to my doctor about QUVIVIQ.”

Taking QUVIVIQ helps her fall asleep faster and stay asleep longer and getting more sleep at night may mean feeling less tired during the day. This is Lindsey’s experience with QUVIVIQ and individual results may vary. Review the additional important safety information and talk with your healthcare provider to see if QUVIVIQ may be right for you.

Lindsey’s advice for others struggling with insomnia

  • 1. Talk about it. It’s common for sleep issues to isolate people or cause them to cope in silence, as problems sleeping can be misconstrued as a “personal” issue. Therefore, Lindsey’s biggest piece of advice for others struggling with sleep like her is to start a conversation with their doctor to discuss the sleep challenges they’re having and to find out what treatment options are out there.
  • 2. Be patient. Lindsey recognizes her issues with sleep didn’t happen overnight, so she knew improving her sleep would take some time to get right. She recommends others be consistent and patient when working through treatment solutions and give them time to work. “Insomnia can impact both my days and my nights. That’s why I take QUVIVIQ nightly, and I feel that my sleep has improved,” she said.
  • 3. Seek support. Paying for treatments can be a concern for many. Those interested in QUVIVIQ should check out QUVIVIQ.com to download or screen shot a QSavings Card. Eligible patients pay as little as $0* for the first month of treatment and receive refills for as little as $25*.

If you’re like Lindsey and struggle with falling asleep or staying asleep, start a conversation with your doctor today and see if QUVIVIQ is right for you. To learn more, visit QUVIVIQ.com.

*For eligible commercially insured patients. Terms and conditions apply. Please read the full terms and conditions.

Sponsored by Idorsia U.S.

What is QUVIVIQ?

QUVIVIQ (daridorexant) 25 mg, 50 mg tablets is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).

Important Safety Information
Do not take QUVIVIQ if you fall asleep often at unexpected times (narcolepsy).

QUVIVIQ may cause serious side effects, including:

  • Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
    • Do not take more QUVIVIQ than prescribed.
    • Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
    • Take QUVIVIQ at night within 30 minutes before going to bed.

QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence.
Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
  • Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.

What should I avoid while taking QUVIVIQ?

  • Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
  • Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.

QUVIVIQ may cause other serious side effects, including:

  • Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
  • Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
  • Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.

The most common side effects of QUVIVIQ are headache and sleepiness.

These are not all of the possible side effects of QUVIVIQ. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide.



[i] Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153.

[ii] Ogunwole S, Rabe M, Roberts A, et al. United States Census Bureau. Population under age 18 declined last decade. https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html. Accessed May 12, 2022.

[iii] QUVIVIQ® (daridorexant) [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals U.S. Inc; 2022.

Finding my routine: Managing my daily life while living with a chronic inflammatory disease

2022-11-04T06:01:00

(BPT) – Content sponsored and provided by Pfizer. Michael partnered with Pfizer to share his experience living with moderate to severe rheumatoid arthritis (RA).

Michael retired from being a professional figure skater to pursue his dream of becoming a fashion designer. He was enrolled as a student in design school when he started having signs of joint inflammation. He originally attributed his joint pain to figure skating.

After thorough testing by his rheumatologist, Michael was diagnosed with moderate to severe rheumatoid arthritis (RA), a chronic inflammatory disease of the joints. At the time, he thought only older people could get the disease, so he was surprised when his doctor told him that he had RA.

At first, it was difficult for Michael to come to terms that he’d be living with RA while he struggled with his ongoing joint pain. “At times, I was in so much pain from my RA that I didn’t want to get out of bed.”

Over time, Michael started to accept his diagnosis and began a daily routine. “I could see that getting into a routine helped me stay motivated and be more positive — I was walking, being as active as possible, eating well and drinking lots of water. Those simple tasks turned into a regular routine for me and is still part of what I do today.”

“You have to know to listen to your body. Doing this has been both the hardest thing and the best thing for me.”

Michael also learned that part of listening to your body is knowing when a treatment plan isn’t working well enough to help manage his symptoms. Michael tried multiple tumor necrosis factor (TNF) blockers, which did not work well enough for him and he continued to experience RA symptoms. As a result, Michael worked with his rheumatologist to find a treatment plan that was right for him.

Michael’s rheumatologist suggested XELJANZ® (tofacitinib), an oral medication for moderately to severely active rheumatoid arthritis when one or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or wasn’t tolerated.

His rheumatologist reviewed the benefits and possible serious side effects of XELJANZ, and discussed the type of laboratory monitoring that would be needed before and during treatment. His rheumatologist also explained that XELJANZ has a BOXED WARNING.

XELJANZ can cause serious side effects and can lower your ability to fight infections; don’t start XELJANZ if you have an infection. Before and during treatment, your doctor should check for infections like tuberculosis (TB), and do blood tests. Serious, sometimes fatal infections, cancers including lymphoma, and lung cancer, blood clots and serious heart-related events have happened. People 50 or older with heart disease risk factors had an increased risk of death. Tell your doctor if you had a heart attack, other heart problems, stroke, or a history of blood clots.

Read more Important Safety Information and Indication below.

Within a few months, Michael could see XELJANZ was a good fit for him. After starting the treatment, he began to notice that he was experiencing less joint pain and swelling.

Michael likes that XELJANZ is an oral option. Through careful discussions with his rheumatologist, Michael was able to find a treatment option that works for him, and now Michael looks forward to getting up and doing activities he enjoys, like spending time with his dog, traveling and designing clothes.

Today, Michael serves as a patient advocate in the community to help others on their RA journey.

Michael’s advice to those starting their own journey with managing RA is to make a list of questions about the symptoms they are experiencing, partner closely with their doctor, and seek resources that are available from the RA community, which includes patient advocacy groups and trusted rheumatological organizations.

“I try to stay positive as much as I can. When I was trying to navigate my RA journey at the beginning, I wanted to find someone in similar shoes as me who has a positive outlook that I could relate to, and now I want to be that person for someone else with RA,” says Michael.

To learn more about XELJANZ, visit XELJANZ.com/RA.

IMPORTANT SAFETY INFORMATION AND INDICATION

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.

Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have symptoms of an infection, including:

  • fever, sweating, or chills
  • cough
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • burning when you urinate
  • urinating more often than normal
  • muscle aches
  • shortness of breath
  • weight loss
  • diarrhea or stomach pain
  • feeling very tired

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.

Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with ulcerative colitis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune system problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

  • Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Are a current or past smoker
  • Have had any type of cancer
  • Have had a heart attack, other heart problems or stroke
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • ixekizumab (Taltz®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drugs
  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

What are other possible side effects of XELJANZ/XELJANZ XR?

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in adults with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in adults with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular course juvenile arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
  • Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

August 2022; PP-XEL-USA-7763

How do you know blood donations are safe?

2022-11-03T11:01:00

(BPT) – Every two seconds, someone in the United States (U.S.) needs blood. A single donation can save lives. However, only 3% of eligible Americans give blood each year.

“When you give blood, you’re giving the gift of life,” said Simone Glynn, M.D., chief of the National Heart, Lung, and Blood Institute’s (NHLBI) Blood Epidemiology and Clinical Therapeutics Branch. “You aren’t just helping patients in critical care, but also those dealing with blood disorders.”

For the person doing the giving, you can be assured that you are doing a great thing, Glynn said. But if you’re the person receiving, can you trust that the blood you’re getting is safe?

Glynn said it’s a very important question. For 30 years, NHLBI has funded programs and research aimed at keeping the nation’s blood supply safe. One of these programs is NHLBI’s Recipient Epidemiology and Donor Evaluation Study, or REDS program. The REDS program conducts research to evaluate and improve the safety of the nation’s blood supply and the safety and effectiveness of transfusion therapies in children and adults. REDS is the largest research program of its kind in the U.S. It addresses potential emerging threats to the blood supply and serves as a resource for ongoing transfusion research. Because of programs like REDS, patients can have confidence that the blood they are receiving is safe.

Another major reason the blood supply is safe and trustworthy, Dr. Kamille West-Mitchell of the National Institute of Health Clinical Center Blood Bank noted, “are the donor screening requirements that blood donation sites have in place to ensure the safety of both donors and blood recipients.” On the day a person shows up to give blood, some of the requirements they must meet are to:

  • Be in good health — meaning that you feel well and can perform normal activities
  • Have a healthy pulse and blood pressure
  • Register a normal temperature — not a fever
  • Meet their state’s minimum age requirement
  • Not have a low hemoglobin level
  • Not have HIV, hepatitis, or risk factors for these infections and other blood transmissible infections
  • Not have donated blood in the last 56 days

Once the person’s blood leaves the donation site, it is carefully tested and screened for major known transfusion-transmissible agents such as HIV and hepatitis B and C to ensure it is safe, then stored at the right temperature before it is shipped where needed.

“Blood is always in demand because it’s perishable. But the good news is most people can donate blood,” West-Mitchell said. Finding a place to donate is simple, as there are blood donation sites in nearly every community. For more information about blood donation and safety, visit the NHLBI’s Blood Diseases & Disorders Education Program at www.nhlbi.nih.gov/education/blood/donation.

Considering goals: Partnering with your doctor to help manage a chronic inflammatory disease

2022-11-02T06:01:00

(BPT) – Dr. Sharma and Ashley were compensated for their participation.

Content sponsored and provided by Pfizer. Ashley and Allegheny Health Network (AHN) rheumatologist Dr. Tarun Sharma partnered with Pfizer to share their different experiences with moderate to severe rheumatoid arthritis (RA).

Note: The image is not the actual patient and physician

Ashley grew up watching her grandmother struggle with rheumatoid arthritis (RA), a chronic inflammatory disease of the joints, and saw first-hand the effects RA could have on a person. When she was diagnosed with moderate to severe RA as an adult, managing her condition became a priority.

“I had concerns about the impacts of living with RA, and I knew that I needed to find a way to help manage my condition,” Ashley explains.

Ashley sought the opinion of several rheumatologists to help manage her RA before establishing an ongoing relationship with Tarun Sharma, MD, a rheumatologist at Pittsburgh-based Allegheny Health Network (AHN). When she met Dr. Sharma, she felt that his approach to care fit her needs and that he listened to her concerns and partnered with her to find a treatment that worked best for her.

Patients with RA, like Ashley, may find it difficult at first to establish a trusting relationship and discuss treatment goals with their rheumatologist. It can sometimes be challenging for patients to articulate the RA symptoms that they are experiencing to their doctor.

Dr. Sharma says he finds that patients may not initially share everything about their RA experiences with their physician but may open up once asked specific questions about how RA impacts their daily activities. “It is important for the patient to feel comfortable being honest about their condition, during an appointment,” says Dr. Sharma. “This helps physicians conduct a comprehensive evaluation and treat the patient’s RA.”

To that end, Dr. Sharma and Ashley work together to manage Ashley’s RA symptoms through ongoing communication. Ashley is now proactive about asking Dr. Sharma questions and is comfortable communicating clearly with him about her RA symptoms. She works closely with Dr. Sharma when making a treatment plan decision or change to her care with the goal of finding a plan suitable for her.

Throughout her disease management journey, Ashley has gone through a lot of trial and error with different treatments for her RA, including trying medicines called tumor necrosis factor (TNF) blockers, but none worked well enough for her. As a result, she did some research online and learned about XELJANZ® (tofacitinib), an oral medication for moderately to severely active rheumatoid arthritis when one or more TNF blockers have been used and did not work well or cannot be tolerated.

Ashley asked Dr. Sharma about XELJANZ. Dr. Sharma reviewed the potential serious side effects of the medication with her and discussed the type of laboratory monitoring that would be needed before and during treatment. Dr. Sharma also explained that XELJANZ has a BOXED WARNING.

XELJANZ can cause serious side effects and can lower your ability to fight infections; don’t start XELJANZ if you have an infection. Before and during treatment, your doctor should check for infections like tuberculosis (TB), and do blood tests. Serious, sometimes fatal infections, cancers including lymphoma, and lung cancer, blood clots and serious heart-related events have happened. People 50 or older with heart disease risk factors had an increased risk of death. Tell your doctor if you had a heart attack, other heart problems, stroke, or a history of blood clots.

Read more Important Safety Information and Indication below.

When Dr. Sharma and Ashley identified XELJANZ as a potential treatment option, they had an open conversation about Ashley’s treatment history and how her symptoms were impacting her at the time, which allowed Dr. Sharma to gather the appropriate data needed. According to Dr. Sharma, “It is important for rheumatologists to have a candid discussion about a patient’s disease management goals to help find a treatment plan that works best for them.”

From a patient perspective, Ashley’s advice to those navigating their own journey with RA is to focus on how you communicate with your doctor and look for ways to enhance active listening and two-way communication. For example, make a list of items you’d like to discuss with your rheumatologist in advance of your appointment and take notes during the conversation so you can refer to them in the future.

“You can’t be afraid to speak up when communicating with your doctor. Your rheumatologist is not going to know what’s going on with your RA symptoms or what your specific concerns are unless you address them directly. If something is on your mind related to your RA management, don’t be shy about addressing it with your doctor,” says Ashley.

Dr. Sharma agrees with Ashley’s tips and emphasizes the importance of proactively communicating developments related to your health and RA treatment plan. “If you have questions or concerns, it’s okay to reach out to your doctor in between visits. Your doctors are there for you, which sometimes requires an additional office visit or conversation,” says Dr. Sharma.

“In my experience, I’ve learned that managing my RA is about finding a balance — between me as an empowered patient and my doctor as the expert guiding me through my medical journey,” says Ashley. “My relationship with Dr. Sharma is an ongoing partnership, with the common goal of ensuring the best care for my RA.”

To learn more about XELJANZ, visit XELJANZ.com/RA.

IMPORTANT SAFETY INFORMATION AND INDICATION

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.

Before and after starting XELJANZ, tell your doctor if you are being treated for an infection,

have infections that keep coming back, or have symptoms of an infection, including:

  • fever, sweating, or chills
  • cough
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • burning when you urinate
  • urinating more often than normal
  • muscle aches
  • shortness of breath
  • weight loss
  • diarrhea or stomach pain
  • feeling very tired

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.

Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with rheumatoid arthritis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune system problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people with rheumatoid arthritis. Some people have died from these blood clots.

  • Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

Before you use XELJANZ, tell your healthcare provider if you:

  • Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
  • Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
  • Have or have had Hepatitis B or C
  • Are a current or past smoker
  • Have had any type of cancer
  • Have had a heart attack, other heart problems or stroke
  • Have had blood clots
  • Have liver or kidney problems
  • Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. You should not take XELJANZ and breastfeed
  • Have had a reaction to tofacitinib or any of the ingredients
  • Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
    • tocilizumab (Actemra®)
    • etanercept (Enbrel®)
    • adalimumab (Humira®)
    • infliximab (Remicade®)
    • rituximab (Rituxan®)
    • abatacept (Orencia®)
    • anakinra (Kineret®)
    • certolizumab (Cimzia®)
    • golimumab (Simponi®)
    • ustekinumab (Stelara®)
    • secukinumab (Cosentyx®)
    • vedolizumab (Entyvio®)
    • ixekizumab (Taltz®)
    • sarilumab (Kevzara®)
    • azathioprine, cyclosporine, or other immunosuppressive drug
  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

What are other possible side effects of XELJANZ/XELJANZ XR?

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in people with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

Common side effects in children (2 & older) with polyarticular course juvenile arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-877-311-8972 to enroll.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
  • Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have bene used, and did not work well or cannot be tolerated

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/XELJANZ XR/XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if XELJANZ XR is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

August 2022; PP-XEL-USA-7764

Can you save $3,000 in 2023? See what’s new for Medicare insurance plans

2022-11-02T16:01:00

(BPT) – The countdown is on! The Medicare Annual Enrollment Period ends Dec. 7, and it’s that time of year when you can change your Medicare plan (that is if you want to!). Now is the time to evaluate your current plan and see if it’s still a good fit.

This year, the top carriers have added several new benefits, making 2023 a good year to find a new Medicare Advantage plan. Here are just a few highlights from the nation’s top insurance carriers.

United HealthCare

  • National rollout of their UCard, which combines customers’ membership cards with their shopping benefit into one integrated card
  • Up to $3,600 to spend on over-the-counter items, groceries, even utilities
  • Enhanced dental benefits on 96% of their Medicare Advantage plans, which covers all non-cosmetic dental care including dentures and implants, and no out-of-pocket costs up to the annual coverage limit on most plans
  • $0 co-pays when visiting your primary care doctor

Cigna

  • Cigna Healthy Today flex card will be available to all plans. The card combines additional benefits and incentives to earn money, up to $200, for wellness activities
  • 25% more plans have the Part B premium rebate benefit, with up to $130 added back to a Medicare customer’s Social Security check every month
  • At least one $0 monthly premium Medicare Advantage plan in every market

Humana

  • Health Option Allowance of up to $3,300 per year will be available for most Dual Medicare Advantage members to spend on things like rent, groceries, utilities, over-the-counter items and more
  • 73% more plans that offer Part B premium giveback
  • Comprehensive dental benefits on some plans with a yearly allowance of $500 or more
  • 78% of new plans have $0 monthly premiums

WellCare

  • $0 monthly premiums, $0 or low co-pays for primary care physicians, and $0 lab and X-ray services on most MA plans
  • Up to $1,000 Flex spending cards are available on many plans for dental, vision, and hearing benefits on some MA plans
  • All Part D plans will include $0 tier 1 (most generic) drugs when filled at preferred pharmacies
  • Amazon is now a preferred pharmacy provider

Aetna

  • Aetna Medicare Extra Benefits Card is a prepaid debit card for over-the-counter items, groceries, utilities and transportation
  • 95% of MA plans will include dental benefits, which include preventive and comprehensive dental services and allows the member to choose any licensed dentist, in or out of network
  • Healthy Rewards Program encourages plan members to improve their health and well-being by rewarding them with $150 or more on personalized activities

With so many new benefits for 2023, it may be overwhelming to choose which plan is right for you. The caring, licensed agents at ClearMatchTM Medicare are patient and helpful, and will check to see if plans with these new benefits are available in your area. And, if they find you are already in a great plan, they’ll tell you so. If you’d like help, call 1-888-921-1286 (TTY:711) for a free Medicare review, Monday-Friday, 9 a.m.-9 p.m., Saturday, 9 a.m.-6 p.m. (ET) or visit ClearMatchMedicare.com, open 24-7.