The promise of progress: Advancing awareness and care for neurofibromatosis type 1

2024-12-03T09:01:00

(BPT) – Every parent prioritizes the health and wellbeing of their child. For most, this means regular checkups and tracking their growth and development. But for some parents like Kim, it’s a different story, filled with hospital visits, multiple surgeries and advocacy for their child living with a rare disease.

When her son Quentin was around nine months old, Kim noticed marks on his torso and back, as well as visible tumors. By 12 months, a larger benign tumor had formed on the right side of his face, wrapping around his facial nerves.

“His cheeks were very full, like if you put two clementines on the side of his mouth and heavy and pulling down his right eye,” said Kim.

At 17 months, Quentin was diagnosed with neurofibromatosis type 1 (NF1), a rare genetic disorder that affects nearly 1 in 3,000 people worldwide. A lifelong and progressive condition, NF1 commonly appears in early childhood and can include spots on the skin, bone issues and other symptoms in the body. Then, at 22 months, Kim learned Quentin had plexiform neurofibromas (PN) — a type of tumor along the nerves of the body that develops in up to 50% of children with NF1. While PN tumors are noncancerous, they can still cause serious problems that impact a child’s quality of life.

“Because the tumor grew and wrapped around his facial nerve, it made it hard for Quentin to chew,” said Kim. “He couldn’t close his eyes, and his baby teeth were trapped inside the PN.”

Finding a management plan

Like many other children with NF1 PN, Quentin’s care was overseen by a team of specialists. For the first couple of years after his diagnosis, Quentin saw 14 physicians between two hospitals. “Our local hospital had a good handle on it, but the tumor was getting bigger, and we felt there was more we could try,” said Kim.

Over the next couple of years, Quentin underwent several surgeries to remove the PN on his face. Surgically removing PNs can be complicated and may not be an option for all patients. One reason is that the PN may be closely intertwined with critical nerves or blood vessels and located near major organs. Further, the PN may not be completely removed by surgery.

For Quentin, the surgeries were unsuccessful in removing the tumor from his face.

“He’s had 10 major surgeries, some that resulted in major complications,” said Kim. “They didn’t work. It was very difficult.”

When Quentin was five years old, one of his doctors determined he was eligible for a clinical trial evaluating a new treatment, selumetinib. His care team discussed with Kim the specific requirements for participation in the trial, including initial testing and continued record-keeping of Quentin’s symptoms, as well as the possible side effects of the treatment.

“Before the clinical trial, Quentin used to have around 20%-30% tumor growth every 3-6 months,” said Kim. “Once he started taking selumetinib, we noticed a significant shrinking of his tumor, and that the growth has since leveled off.”

This investigational treatment was approved by the FDA in April 2020 as KOSELUGO® (selumetinib) which became the first and only prescription medicine for pediatric patients two years of age and older with NF1 who have symptomatic and inoperable PNs. KOSELUGO has been shown to reduce the size of some PNs, advancing care for children like Quentin who have inoperable PNs.

Quentin did experience some side effects, such as diarrhea, eczema and hair loss, but the progress was visible — his tumors were not growing, and Quentin has been taking KOSELUGO ever since.

The challenges and triumphs

Today, Quentin is 17 years old. He is still managing his NF1 PN, but thanks to his care team and support from his family and friends, he is a social and active teenager living an active life. Whether on the volleyball court or the baseball diamond, he is grateful for each opportunity.

“NF1 has shaped our lives positively and negatively,” said Kim. “Before we started therapy, he was in and out of the hospital and was septic at times. But on the positive side, NF1 made us closer, stronger and better communicators. We don’t take anything for granted.”

Quentin has been aware of his condition since he was four years old. Now, he unapologetically tells people he has NF1 PN and that there’s no cure. “Some days you’re swimming in the ocean, and some days asking for a life preserver,” reflected Kim.

For other parents and caregivers navigating their child’s NF1 PN diagnosis, Kim says that education and seeking resources are key.

“I can’t stress enough to advocate for your child and be educated yourself. Ask the questions. Ask, ask, ask,” she said. “Ask about support networks, what’s available in your community, and ask your doctors all the questions. You need to be educated in order to take care of someone else.”

This article is sponsored by Alexion, AstraZeneca Rare Disease.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of Koselugo?

Koselugo may cause serious side effects, including:

  • Heart problems. Koselugo can lower the amount of blood pumped by your heart, which is common and can also be severe. Your healthcare provider will do tests before and during treatment to check how well your heart is working. Tell your healthcare provider right away if you get any of the following signs or symptoms: persistent coughing or wheezing, shortness of breath, swelling of your ankles and feet, tiredness, increased heart rate.
  • Eye problems. Koselugo can cause eye problems that can lead to blindness. Your healthcare provider will check your vision before and during treatment. Tell your healthcare provider right away if you get any of the following signs or symptoms: blurred vision, loss of vision, dark spots in your vision (floaters), other changes to your vision.
  • Severe diarrhea. Diarrhea is common with Koselugo and can also be severe. Tell your healthcare provider right away the first time that you get diarrhea during treatment. Your healthcare provider may give you medicine to help control your diarrhea and may tell you to drink more fluids.
  • Skin rash. Skin rashes are common with Koselugo and can also be severe. Tell your healthcare provider if you get any of the following signs or symptoms: rash that covers a large area of your body, peeling skin, blisters.
  • Muscle problems (rhabdomyolysis). Muscle problems are common with Koselugo and can also be severe. Treatment with Koselugo may increase the level of a muscle enzyme in your blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare provider should do a blood test to check your muscle enzyme levels of CPK before you start taking Koselugo and during treatment. Tell your healthcare provider right away if you get any of the following signs or symptoms: muscle aches or pain; muscle spasms and weakness; dark, reddish urine.

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

  • have heart problems.
  • have eye problems.
  • have liver problems.
  • are pregnant or plan to become pregnant. Koselugo can harm your unborn baby. Your healthcare provider should verify if you/your partner are pregnant before beginning treatment. Ensure you/your partner use effective birth control (contraception) during treatment and for 1 week after your last dose if there is possibility pregnancy could occur. Tell your healthcare provider right away if you/your partner think you may be pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Koselugo passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you are taking aspirin, blood thinners, or other medicines to treat blood clots. Koselugo contains vitamin E, which may increase risk of bleeding.

What should I avoid while taking Koselugo?

Do not drink grapefruit juice, eat grapefruit, or take supplements with grapefruit or St. John’s Wort during treatment.

Most common side effects include: vomiting, stomach-area pain, nausea, dry skin, muscle and bone pain, feeling of tiredness or lacking energy, fever, sores in your mouth, headache, redness around the fingernails, itching.

These are not all the possible side effects of Koselugo. Call your healthcare provider for medical advice about side effects. Your healthcare provider may change your dose, temporarily stop, or permanently ask you to stop taking Koselugo if you have any of these side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or at https://us-aereporting.astrazeneca.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

What is Koselugo?

Koselugo is a prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age.

Please see Patient Information in the full Prescribing Information for Koselugo (selumetinib).

AstraZeneca and its Rare Disease Unit, Alexion, are committed to raising awareness of the disease and the need for treatment options. Learn more at Alexion.com and Astrazeneca-us.com. You can also visit Koselugo.com.

KOSELUGO is a registered trademark of the AstraZeneca group of companies. ALEXION is a registered trademark of Alexion Pharmaceuticals, Inc. © 2024, Alexion Pharmaceuticals, Inc. All rights reserved. All other trademarks are property of their respective owners.

US/KOS-NF1/0806 V1 07/2024

Recognizing Polymyalgia Rheumatica: An Expert’s Guidance to Early Diagnosis, Treatment Options, and Symptom Management

2024-11-27T08:01:00

(BPT) – As people age, it’s sometimes easy to attribute body aches to daily routines or external factors. However, stiffness and pain in a person’s shoulders, neck or hips could signal something more serious, like polymyalgia rheumatica (PMR).

PMR is a type of inflammatory rheumatic disease that impacts around 1 in 2,000 people aged 50 and above, with women more likely to be affected, and the risk of developing it increases with age.1-2 Many people with PMR report worsening symptoms in the morning or after periods of inactivity, particularly when performing everyday tasks like lifting objects or standing up. Recognizing the early signs of PMR and talking to a doctor are important to figuring out a treatment plan to help manage symptoms.

Dr. Grace Wright, MD, PhD, president of the Association of Women in Rheumatology and a practicing rheumatologist in New York City, explains how doctors can guide their patients through their diagnosis and treatment experience. She explains that by encouraging open communication between patients and doctors, “patients can feel empowered and informed throughout their care journey.”

Consult Your Doctor Early: Addressing PMR Symptoms for Timely Diagnosis and Treatment

  • Patients should consider talking to their doctor about potential PMR symptoms such as muscle and joint pain as soon as they notice any significant changes in their day-to-day life. Dr. Wright urges patients to openly describe how they’re feeling like, “I can’t get up from a chair,” or “I’m having difficulty putting away objects over my head.” If there is a sudden onset of symptoms, it is important to seek medical attention immediately. Even with a more gradual onset of PMR, when aches and stiffness slowly develop over time, patients should still consult with their doctor early.

Effective Communication: Differentiating PMR Symptoms for Accurate Diagnosis

  • Listening closely to patients’ concerns and understanding their full experience can help doctors accurately differentiate PMR symptoms from other conditions. For example, understanding extreme fatigue compared to general malaise can help distinguish PMR from another common inflammatory disease, like arthritis. Dr. Wright encourages patients to focus on the functional changes in their routine when describing symptoms. On top of saying “my muscles feel weak,” they can also be more descriptive by saying, “I can no longer drink out of a coffee mug. I have to use a plastic cup instead.” These types of details can help give doctors clear systemic signs of PMR, demonstrating pain and inflammation, which are important symptom identifiers for a diagnosis.

Managing PMR: Understanding Treatment Options and the Importance of Monitoring Health Conditions

  • In the patients that Dr. Wright has treated, she states that there are ways people can manage their condition, beginning with treatments such as corticosteroids to help reduce inflammation and alleviate pain. However, given patients can initially be prescribed a high dose of corticosteroids, Dr. Wright says physicians should, “closely monitor side effects like high blood pressure and elevated blood sugar.” She says, “For patients who live with health conditions like diabetes or heart disease, it’s important that they inform their doctor, as taking steroids—which can work quickly to provide PMR symptom relief and is tapered off to avoid flares—can potentially also worsen existing health conditions.” Healthy lifestyle changes may also help people living with PMR manage their symptoms. “Incorporating gentle exercise or physical therapy can help maintain muscle tone and mass,” says Dr. Wright. Sometimes PMR symptoms may improve with the help of steroids, but if a patient is not finding relief in their current treatment plan, they should talk with their doctor about other options.

Resources and Support to Stay Informed

  • A PMR diagnosis can be challenging and can make one feel alone. It’s important that people living with PMR tell their family, friends and loved ones how they are feeling and also not be afraid to ask for help. Dr. Wright encourages her patients to stay informed and be proactive about managing their condition. There are organizations to help connect patients with one another and provide educational resources like CreakyJoints (part of the Global Health Living Foundation) and also the Arthritis Foundation. PMRandYou is another online resource where patients can get additional information.

Another Option for Treating PMR

  • KEVZARA® (sarilumab), an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker, is used to treat adult patients with PMR after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated. Il-6 is an immune system protein, which can cause the immune system to attack healthy cells if there is too much of it in the body. High levels of IL-6 are believed to play an important role in PMR symptoms. To learn about KEVZARA, practical tips for living with PMR, and to determine if this treatment is suitable for you, visit www.kevzara.com/pmr.

Important Safety Information

KEVZARA® (sarilumab) can cause serious side effects including:

  • SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have had serious infections while using KEVZARA, including 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 KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA.
  • Before starting KEVZARA, tell your healthcare provider if you
    • think you have an infection or have signs or symptoms of an infection, with or without a fever such as sweats or chills, muscle aches, a cough, 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 normal, if you feel very tired, or if you are being treated for an infection, get a lot of infections or have repeated infections.
    • have diabetes, HIV, or a weakened immune system.
    • have TB, or have been in close contact with someone with TB.
    • live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis).
    • have or have had hepatitis.
  • After starting KEVZARA, call your healthcare provider right away if you have any symptoms of an infection.
  • CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your healthcare provider should do blood tests before and after starting KEVZARA to check for low neutrophil (white blood cells that help the body fight off bacterial infections) counts, low platelet (blood cells that help with blood clotting and stop bleeding) counts, and an increase in certain liver function tests. Changes in test results are common with KEVZARA and can be severe. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests 4 to 8 weeks after starting KEVZARA and then every 6 months during treatment to check for an increase in blood cholesterol levels.
  • TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Tell your healthcare provider if you have had a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people using KEVZARA get tears in their stomach or intestines. Some people using KEVZARA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatorydrugs (NSAIDS), corticosteroids, or methotrexate. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.
  • CANCER: KEVZARA may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.
  • SERIOUS ALLERGIC REACTIONS: Serious allergic reactions can happen with KEVZARA. Get medical attention right away if you have any of the following signs: shortness of breath or trouble breathing; feeling dizzy or faint; swelling of your lips, tongue, or face; moderate or severe stomach (abdominal) pain or vomiting; or chest pain.
  • Do not use KEVZARA if you are allergic to sarilumab or any of the ingredients of KEVZARA.
  • Before using KEVZARA, tell your healthcare provider if you
    • have an infection.
    • have liver problems.
    • have had stomach (abdominal) pain or a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines.
    • recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines.
      • All vaccines should be brought up-to-date before starting KEVZARA, unless urgent treatment initiation is required.
    • plan to have surgery or a medical procedure.
    • are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk.
    • take prescription or nonprescription medicines, vitamins, or herbal supplements. It is especially important to tell your healthcare provider if you use:
      • any other medicines to treat your RA or PMR. Using KEVZARA with these medicines may increase your risk of infection.
      • 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.
  • The most common side effects include:
    • injection site redness
    • injection site itching
    • upper respiratory tract infection
    • urinary tract infection
    • nasal congestion, sore throat, and runny nose

These are not all the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

To learn more, talk about KEVZARA with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com or by calling 1-844- KEVZARA.

Please click here to see full Prescribing Information including risk of SERIOUS SIDE EFFECTS and Medication Guide.

References

  1. The Lancet. “Polymyalgia rheumatica.” Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01310-7/abstract
  2. National Library of Medicine. “An update on polymyalgia rheumatica.” Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9796644/

MAT-US-2410843-v1.0-11/2024

Deserving More: Sherly’s Journey to Managing Migraine Attacks

2024-11-26T09:01:00

(BPT) – By Sherly P.

Coming of age in Puerto Rico, life was vibrant. As a family matriarch, I baked, cooked, and cared for 30+ relatives. My house was always the center of our family’s activities. Unseen against the backdrop of family events, tables of food and the paradise that is Puerto Rico was my daily experience of living with migraine disease. I never allowed chronic migraine to slow down my education, career or impact my family, but it wasn’t always easy.

Through my early 30s, my migraine attacks were mild and manageable. I earned two master’s degrees, opened my own bakery, worked as a professional counselor and became a university professor. I also raised two rescue dogs, traveled the world, and maintained a busy social life.

Everything came to a crushing halt, and my migraine began to spiral out of control, after a serious injury in October 2012. I opened my eyes after an eight-hour surgery, but I didn’t register the back pain because I was in the throes of the most excruciating migraine attack of my life. Immediately after surgery, my migraine symptoms intensified to include sensitivity to daylight, certain foods, and smells. Light sensitivity was impacting me so severely that I shifted to a nocturnal schedule to avoid daylight, making me feel like a vampire.

This rapid change started years of cycling through neurologists and various treatments in my desperate attempt to regain some control: acupuncture, vitamins, infrared light, yoga and even Himalayan sea salt in my coffee. Nothing worked for me.

Migraine pain became my new normal, robbing me of my health and happiness, and before long, the impact of my migraine disease was too much to bear. I lost my job, abandoned my studies, and retreated from family functions and socializing. The emotional low point came when my own loved ones accused me of exaggerating or faking my symptoms. The severity of it all led to self-isolation, anxiety, and depression. Medical professionals implied my suffering was just “in my head.” I decided that I deserved more out of my migraine treatment plan and a neurologist who listened, believed, and validated the severity and impact of my migraine disease over my whole health. Finally, a recommendation led to a new neurologist who was both a migraine specialist and living with migraine herself. Finding her was my turning point as she combined migraine expertise with human empathy.

When I first visited her six years ago, she helped me understand the impact migraine was having on my life, and she was the first person in five years to validate the severity of my condition. I told her my migraine treatment plan wasn’t working, and I needed to make a change. We developed an action plan to get a clearer picture of possible triggers for my migraine attacks. Armed with this information, we set out in search of a different treatment plan that would help address the severity of my disease and limitations. While I was in the waiting room for a follow-up appointment, I came across a brochure for VYEPTI® (eptinezumab-jjmr), a prescription medicine used for the preventive treatment of migraine in adults. What jumped out at me with VYEPTI is that it’s administered by a healthcare provider four times a year (every three months) via intravenous (IV) infusion. I brought the brochure to my neurologist to discuss it during our appointment. Together we discussed the potential benefits and risks of VYEPTI, and we decided to give it a try. After starting treatment with VYEPTI, I noticed my overall migraine symptoms were becoming less severe.

Finally, I started being able to go back out on my balcony and enjoy the sunshine. Before long, I was experiencing intervals where I would go three or four days without a migraine attack — a huge improvement.

In patients with 4 or more migraine days a month, VYEPTI has been proven to reduce monthly migraine days over months 1-3 compared to placebo. However, individual results may vary and you should not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. See additional Important Safety Information for VYEPTI below.

With more migraine-free days, my house is once again the home to my family. I’m finally making plans! I’m even going to a concert soon, since it seems I can enjoy music again. I also plan to go back to school to get my Ph.D. in naturopathy. Migraine disease taught me the importance of putting myself first because I deserved more. With my migraine attacks less frequent and severe, I feel like my mental and physical health has improved. The biggest reward were the words from my therapist of 20 years, “finally, I see you again!”

Check out the doctor discussion guide on vyepti.com to get started today.

APPROVED USE
VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Do not receive VYEPTI if you have a known allergy to eptinezumab-jjmr or its ingredients.

VYEPTI may cause allergic reactions. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction: rash; swelling of your face, lips, tongue, or throat; if you have trouble breathing; hives; or redness in your face.

Before starting VYEPTI, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant, or you are breastfeeding or plan to breastfeed.

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

The most common side effects of VYEPTI include stuffy nose and scratchy throat, and allergic reactions.

These are not all the possible side effects of VYEPTI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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.

For more information, please see the Prescribing Information and Patient Information or go to vyepti.com.

© 2024 Lundbeck. All rights reserved. VYEPTI is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-101669

How to Help Families and Friends Prevent Respiratory Illnesses This Holiday Season

2024-11-20T11:01:00

(BPT) – By Sanofi

The holiday season is upon us — along with the many in-person gatherings that come along with it. This time of year, it’s important to know how to help keep your family protected from illnesses like the flu, respiratory syncytial virus (RSV) and whooping cough.

In the winter months, we often see a rise in cases of the flu and RSV.[1] But there are several preventive actions we can take to help avoid getting sick this holiday season. Avoiding gatherings when you are not feeling well, covering your mouth when you cough, and washing your hands can help stop the spread of germs and prevent respiratory illnesses.[2] Immunizations can also be key to helping avoid serious complications from respiratory illness. Some immunizations can help to keep your family and friends protected.[3]

“As we enter the holiday season, it’s critical to ensure that all eligible members of your family are up to date on their immunizations, particularly as illnesses can spread through close contact during holiday gatherings,” said Dr. Sean X. Leng, geriatric medicine and infectious disease expert.

According to the Centers for Disease Control and Prevention (CDC), maintaining a routine immunization schedule is one of the best ways to help protect against certain respiratory illnesses.[4] If you are headed to your healthcare provider or pharmacy for an annual flu vaccine, it can be a good time to ensure eligible members of your family are also up to date on other immunizations.

The Risk of Complications of the Flu in Vulnerable Populations

Flu vaccinations can help reduce the burden of illness and hospitalization — especially for people who are at higher risk of developing serious complications, such as older adults or people with chronic conditions like lung or heart disease.[5]

Anyone can catch the flu, but people 65 years and older bear the greatest burden of severe illness and flu-related hospitalizations.[6] The CDC estimates that 70% to 85% of seasonal flu-related deaths occur in people of this age group, making them a high priority for receiving vaccination.[6]

Several vaccines are available for more vulnerable, older adult populations including Sanofi’s Fluzone® High-Dose (Influenza Vaccine) and Flublok® (Influenza Vaccine).[7],[8] Flublok and Fluzone High-Dose are vaccines indicated for the prevention of disease caused by influenza A and B strains contained in (or in the case of Flublok represented by antigens contained in) the vaccine.[7],[8] Flublok is given to people 18 years of age and older.[8] Fluzone High-Dose is given to people 65 years of age and older.[7] Flublok or Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including egg or egg products for Fluzone High-Dose).[7],[8] In addition, Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.[7] See below for additional Important Safety Information about Flublok and Fluzone High-Dose.

Helping to Protect Babies from Serious Lung Infection Caused by RSV

Healthcare worker wearing rubber gloves placing a bandage on a baby's leg after having given her a vaccination.

It is equally important to help provide protection for babies who are at risk of developing a serious lung infection caused by RSV.[9],[10] The holiday season can bring an increase in cases, as RSV can be spread from a kiss or touching a shared toy.[11]

“RSV is a highly contagious virus that can progress from mild cold-like symptoms to hospitalization in less than a week.[12] While hospitalization is uncommon, it is the most common cause of hospitalization in babies, with a staggering two out of three getting RSV by age 1,”[9] said Dr. Kerry-Anne Perkins, Board-Certified Obstetrician-Gynecologist (OB-GYN).

There is an immunization to help prevent serious lung infection caused by RSV.[13] Beyfortus® (nirsevimab-alip) 50mg and 100mg Injection is a preventative antibody that helps provide an extra layer of protection against serious RSV lung infections for babies under 1 born during or entering their first RSV season, and certain kids up to 24 months.[13] Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus. Beyfortus may not protect all children.[13] See below for additional Important Safety Information about Beyfortus.

Continuing the Conversation About Immunizations

And while respiratory illnesses are top of mind, it’s a good time to ensure that eligible members of the family are up to date with a Tdap vaccine, such as Adacel® (Tdap vaccine), to help combat the risk of whooping cough (pertussis). In addition to whooping cough, Tdap vaccines help prevent diphtheria and tetanus.[14] Adacel is indicated for:

  • active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.[14]
  • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.[14]

You should not take Adacel if you’ve had severe allergic reaction (e.g., anaphylaxis) to any component of Adacel or any other diphtheria toxoid, tetanus toxoid and pertussis antigen-containing vaccine.[14] See below for additional Important Safety Information about Adacel.

Whooping cough also poses a serious risk for babies and young children.[15] The bacterial infection, also known as pertussis, can cause uncontrollable and violent coughing.[15] It can be extremely serious and even deadly for babies and young children.[15]

While infection rates had been falling in previous years, the United States is beginning to return to pre-pandemic patterns.[16]

Be a Health Advocate This Season

Immunizations are a great tool to help protect eligible members of your family during times of peak illness and throughout the year.[1],[3] Talk to your healthcare provider to learn more about options that may be right for you or your loved ones this holiday season.

IMPORTANT SAFETY INFORMATION FOR FLUBLOK® (INFLUENZA VACCINE) AND FLUZONE® HIGH-DOSE (INFLUENZA VACCINE)

Flublok or Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including egg or egg products for Fluzone High-Dose). In addition, Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.

If Flublok or Fluzone High-Dose are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination with Flublok or Fluzone High-Dose may not protect all people who receive the vaccine.

Fainting has occurred following vaccination with Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

For Flublok, in adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older the most common side effects were pain where you got the shot, tiredness and headache.

For Fluzone High-Dose, in adults 65 years of age and older, the most common side effects were pain where you got the shot, muscle pain, tiredness, and headache.

For Flublok and Fluzone High-Dose, other side effects may occur.

Before administration, please see the full Prescribing Information for Flublok, or Fluzone High-Dose. Also, please see complete Patient Information for Fluzone High-Dose.

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BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection INDICATION

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:

  • Newborns and babies under 1 year of age born during or entering their first RSV season.
  • Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

IMPORTANT SAFETY INFORMATION

Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus.

Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:

  • has ever had a reaction to Beyfortus.
  • has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received Beyfortus in the same RSV season.

Serious allergic reactions have happened with Beyfortus. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:

  • swelling of the face, mouth, or tongue
  • difficulty swallowing or breathing
  • unresponsiveness
  • bluish color of skin, lips, or under fingernails
  • muscle weakness
  • severe rash, hives, or itching

The most common side effects of Beyfortus include rash and pain, swelling, or hardness at the site of your child’s injection. These are not all the possible side effects of Beyfortus. Call your healthcare provider if you have questions about side effects.

Please see full Prescribing Information, including Patient Information, for more details.

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ADACEL (Tdap vaccine) INDICATION

Adacel is a vaccine indicated for:

  • active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
  • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

IMPORTANT SAFETY INFORMATION

Adacel is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any other tetanus toxoid, diphtheria toxoid, or pertussis containing vaccine, or to any component of Adacel; or encephalopathy within 7 days of a previous dose of a pertussis containing vaccine with no other identifiable cause.

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

If Guillain-Barré syndrome or brachial neuritis has occurred within 6 weeks following previous vaccination with a tetanus toxoid or if progressive or unstable neurologic disorders exist, the decision to give Adacel should be based on careful consideration of the potential benefits and risks.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine.

Some individuals with altered immunocompetence, including receiving immunosuppressant therapy, may have reduced immune responses to Adacel.

Syncope can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions.

After the first and second dose of Adacel, the most frequently reported solicited reactions were pain, swelling, and erythema at the injection site; headache, body ache or muscle weakness, tiredness, myalgia, and malaise.

Other adverse reactions may occur. Vaccination with Adacel may not protect all individuals.

Please click to see full Prescribing Information.

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[1] Centers for Disease Control and Prevention. Flu Season. Available at: https://www.cdc.gov/flu/about/season.html. Accessed October 2024.

[2] Centers for Disease Control and Prevention. Preventing the Flu: Good Health Habits Can Help Stop Germs. Available at: https://www.cdc.gov/flu/protect/habits/index.htm. Accessing October 2024.

[3] Centers for Disease Control and Prevention. Immunizations for Respiratory Viruses Prevention. Available at: https://www.cdc.gov/respiratory-viruses/prevention/immunizations.html. Accessed October 2024.

[4] Centers for Disease Control and Prevention. Vaccine Schedules for You and Your Family. Available at: https://www.cdc.gov/vaccines/imz-schedules/index.html. Accessed October 2024.

[5] Centers for Disease Control and Prevention. Benefits of the Flu Vaccine. Available at: https://www.cdc.gov/flu-vaccines-work/benefits/index.html. Accessed October 2024.

[6] Centers for Disease Control and Prevention. Flu and People 65 Years and Older. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Accessed October 2024.

[7] Fluzone High Dose [Prescribing Information]. Swiftwater, PA: Sanofi.

[8] Flublok [Prescribing Information]. Swiftwater, PA: Sanofi.

[9] Centers for Disease Control and Prevention. RSV in infants and young children. Available at: https://www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed October 2024.

[10] Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-546.

[11] Centers for Disease Control and Prevention. How RSV Spreads. Available at: https://www.cdc.gov/rsv/causes/index.html. Accessed October 2024.

[12] Centers for Disease Control and Prevention. About RSV. Available at: https://www.cdc.gov/rsv/about/index.html. Accessed October 2024.

[13] Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi.

[14] Adacel. [Prescribing Information]. Sanofi.

[15] Centers for Disease Control and Prevention. Symptoms of Whooping Cough. Available at: https://www.cdc.gov/pertussis/signs-symptoms/index.html. Accessed October 2024.

[16] Centers for Disease Control and Prevention. About Whooping Cough Outbreaks. Available at: https://www.cdc.gov/pertussis/outbreaks/index.html. Accessed October 2024.

MAT-US-2410270-v1.0-10/2024

Need affordable vision care? How Medicare Advantage can help

2024-11-20T06:01:00

(BPT) – The end of the Medicare Open Enrollment Period (OEP) is fast approaching. By Dec. 7, it’s important that eligible adults choose a plan that fits their needs, especially when it comes to vision care benefits.

Not all Medicare plans provide vision care. Some require beneficiaries to pay 100% of the cost for routine eye exams, eyeglasses or contacts. To ensure you can afford vision care in 2025, it’s crucial that you carefully review your plan’s benefits.

Why vision care matters

Vision difficulties are common among Medicare beneficiaries. According to the Kaiser Family Foundation (KFF), 35% of beneficiaries reported difficulty seeing in 2019.

Seeing clearly isn’t the only reason older adults need vision care. Routine eye exams can also help detect signs of over 270 health conditions, including diabetes, high blood pressure, autoimmune diseases and cancers.

Does Medicare Advantage cover vision?

Original Medicare does not cover vision. You’ll be on the hook for the full price of a routine eye exam, which can range from $75-$200 for patients without vision insurance.

Luckily, Medicare Advantage (or Medicare Part C) plans often do, which can significantly reduce out-of-pocket costs for seniors. In fact, KFF found that beneficiaries enrolled in Medicare Advantage plans spent less out-of-pocket on vision care than beneficiaries in traditional Medicare in 2018.

Because Medicare Advantage plans are offered by Medicare-approved private insurance companies, vision care benefits may vary. If you qualify for Medicare Advantage but have not signed up, consider doing so this year.

If you’re on a Medicare Advantage plan, make sure to review your vision care benefits in case of changes. It’s also a good idea to compare Medicare Advantage plans to make sure you’re getting vision care that you can afford and that meets your vision needs.

You have options

If your Medicare plan doesn’t cover all your vision needs, you still have options for vision care benefits. Separate vision insurance, like a plan through VSP® Individual Vision Plans, can help complete your coverage at an affordable price.

VSP vision insurance offers coverage for routine eye exams, glasses and lens enhancements, which are not covered by Original Medicare. Because VSP doesn’t have open enrollment or waiting periods, you can purchase and use your vision insurance plan at any time. You’ll also have access to a large doctor network, so you don’t need to stress about finding an eye doctor near you.

Benefits include 20% off additional glasses or sunglasses, including lens enhancements, from a VSP network doctor within 12 months of your last exam.

Whether you have Medicare Advantage or not, you can make sure you have access to vision care you can afford with the benefits you need to keep your vision healthy.

Visit VSPDirect.com to find the best vision plan for you. While you’re there, you can also compare insurance plans and see which one meets your needs.

5 tips for breathing easier during cold and flu season

2024-11-12T09:01:00

(BPT) – Did you ever wonder why it may be harder to breathe during cold and flu season? Cold air, for one thing. Cold air can irritate airways and make them narrower, increasing mucus production. What else makes you feel stuffy? Spending more time indoors during cold weather may expose you to poor air quality from closed doors, sealed windows and stale air from heating systems which may leave you feeling congested. And, sometimes your nose is blocked due to inflammation and mucus buildup caused by an actual cold or flu virus.

When you’re feeling stuffy, here are five tips for clearing your nasal passages to help you breathe easier:

Take a hot shower: The steam created in a hot shower can open your sinuses and help loosen mucus. If a shower isn’t available, you can lean over a bowl of hot water. Covering your head with a towel or other cloth can keep the steam in.

Use a humidifier: Adding moisture to the air with a humidifier can prevent your nasal passages from drying out. Be mindful to keep your humidifier clean.

Stay hydrated: Fluids — from chicken soup to cups of your favorite tea — will help loosen the goo in your nose and lungs. Research shows your body needs more fluid for quick relief and to fight off infection.

Flush out the mucus: Nasal irrigation is a safe and easy way to clean your nose when you’re stuffed up during cold and flu season. An excellent option is Navage Nasal Care, the #1 doctor recommended drug-free nasal irrigation device according to an independent study of 300 Ear, Nose and Throat specialists. Navage uses gentle, powered suction and a Saltpod® containing saline concentrate that is combined with distilled, boiled or bottled water to flush out mucus, help with postnasal drip and relieve sinus congestion and sinus headaches. Naväge works fast to flush, moisturize and cleanse the nasal cavity. Find Naväge online at www.navage.com and in many national retailers.

Add a few pillows when you sleep: Elevating your head during sleep can help with mucus drainage and reduce congestion.

Data show that nose breathing not only makes you feel better, it is also good for your heart with positive effects including decreasing blood pressure and heart rate.

“A stuffy nose is one of the most commonly experienced and annoying symptoms during cold and flu season,” said Howard L. Levine MD, listed as one of The Best Doctors in America and Top Doctors in Cleveland, world-renowned expert in nasal and sinus disorders, and consultant to Naväge. “Breathing easier — and especially through your nose — provides real relief.”

Sleep First to Help Prevent Drowsy Driving

2024-11-07T07:01:00

(BPT) – Drowsy driving is risky and dangerously common. Many drivers are either unaware or don’t prioritize getting enough sleep as an important part of safe driving. Even though drowsy driving is high risk — the cause of nearly one in five deadly car crashes — many people continue to drive when they’re not fully alert.

Did you know that getting only 3-4 hours of sleep is similar to having a few drinks? It’s time to start thinking about drowsy driving more like drunk driving. New data from the National Sleep Foundation’s (NSF) 2024 Drowsy Driving survey show only four in 10 adults are likely to find alternatives to driving when they haven’t gotten enough sleep, whereas nearly seven in 10 adults are likely to find alternatives to driving after a few drinks.

Even if you’ve had some sleep, it may not be enough. The survey found just 50% of adults are likely to avoid driving when they haven’t gotten the sleep they need, but almost 90% of adults are likely to avoid driving when they’ve had a few drinks. More people have urged someone not to drive because of drinking than for being too sleepy or tired. However, if you haven’t had enough quality sleep to drive alert, it’s not safe for you to be behind the wheel.

Drowsy driving is impaired driving. As part of its continued commitment to educate the public about the importance of sleep for health and well-being, NSF produces Drowsy Driving Prevention Week® every year to encourage everyone to Sleep First. Drive Alert.® Here’s a short list of things you can do before you get behind the wheel.

Prioritize Sleep Ahead of Your Drive

It is important to get the recommended amount of sleep the night before your trip. While the feeling of a good night’s sleep varies from person to person, NSF recommends seven to nine hours of sleep per night for adults and eight to 10 hours for teens.

Woman peacefully sleeping in bed.

Bring a Buddy: Plan to Have a Companion for Your Longer Trips

A companion passenger can not only help look for early warning signs of driver fatigue or sleepiness but can also help with driving when needed. A good driving co-pilot is someone who stays awake to talk to you and will be aware of your alertness. They can be particularly helpful on long trips. As you plan your next adventure, consider inviting along a driving buddy or two to make your trip safer and more memorable.

Couple on a road trip taking turns driving.

Proper Planning: Schedule Regular Stops for Your Trip

Plan a stop every 100 miles or two hours during your driving trip. Stops help you stay alert by giving you a chance to check your alertness, stretch, or rest a bit if you need to. Schedule some stops that are meaningful to you in addition to your necessary breaks. For instance, you could stop by a park for a quick stretch or walk along a scenic path before hitting the road again.

Group of three friends leaning on a car figuring out their trip using a map.

Look Out for the Signals of Drowsy Driving

Be aware of the warning signs that come with drowsy driving. Frequent blinking and yawning or having difficulty with lane and speed control are common signs that you may be too tired to drive. A companion driver can help keep an eye on the warning signs of drowsy driving, too. Remember: a drowsy driving crash can happen in just seconds. If you notice these warning signs, take action — pull over to a safe place and take a quick nap.

Woman covering a yawn while driving in a car.

NSF has more science-backed recommendations to help anyone and everyone be their Best Slept Self®. It’s the place to start and can make a big difference to help avoid drowsy driving. There are simple things you can do every day and night to help you get enough of the quality sleep you need.

During the day, things like spending time in bright, natural light, getting regular exercise and eating meals at consistent times can help your body prepare for sleep. At night, NSF recommends avoiding things like heavy meals, caffeine and alcohol, keeping a wind-down routine, and sleeping in a place that’s cool, dark, and quiet — which also means putting your screen devices away an hour before bed.

Visit theNSF.org for more key tips while you make your own plan to prevent drowsy driving, plus get NSF’s expert resources to help you be your Best Slept Self®.

The National Sleep Foundation (NSF) is an independent 501(c)3 nonprofit organization dedicated to improving health and well-being through sleep education and advocacy. Founded in 1990, the NSF is committed to advancing excellence in sleep health theory, research and practice.

NSF thanks its Drowsy Driving Prevention Week® 2024 sponsors, GM, Schneider National and Waymo for their support and commitment to helping the public stay safe on the road.

3 Apple-Inspired Activities to Enjoy this Fall

2024-11-07T12:01:00

(BPT) – Sponsored by Bare Snacks

Fall is such a beautiful time of year — crunching through the leaves, pulling out the cozy sweaters, and best of all, enjoying popular seasonal flavors! Fall’s favorite fruit, apples, start to ripen for fall so it only makes sense to give apples the spotlight they deserve for their nutritious benefits and delicious, crisp taste.

There are so many ways to experience the simple joys of apples with fall-inspired activities. Here are three ways to enjoy and appreciate the bounty of the season while making precious memories with loved ones before the season shifts once again.

1. Go Apple Picking

Fall is a great time to visit one of many apple orchards bursting with apples of all varieties ready for picking. Seasonal outings provide a great bonding moment with friends and family to make memories and enjoy apples with a new appreciation for how they are grown and harvested. How to enjoy all those apples once they’ve been picked from the tree? Along with classics like apple pies or apple cider donuts, try an even simpler recipe such as Cinnamon Baked Apples, which pairs freshly picked apples with some extra crunch from Bare® Apple Chips.

Cinnamon Baked Apples Recipe

Makes 8 servings

Ingredients

  • 1/4 cup Bare® Apple Chips
  • 1/2 cup old fashioned oats
  • 2 tablespoons coconut sugar
  • 1/2 teaspoon ground cinnamon
  • 1/4 teaspoon ground cloves
  • 1/4 teaspoon ground nutmeg
  • Pinch of salt
  • 1 teaspoon vanilla extract
  • 4 Granny Smith, Fuji or Honeycrisp apples
  • 1 cup water
  • 2 tablespoons coconut oil

Instructions

Preheat oven to 375°F. In a small bowl, mix together oats, sugar, cinnamon, cloves, nutmeg, salt, Bare® Apple Chips, and vanilla extract, then set aside. Use an apple core utensil to remove cores from apples. Place in a square baking dish. Tightly pack filling into each apple core. Pour one cup of water into the bottom of the dish. Loosely cover dish with foil and bake at 375°F for 20 minutes. Remove foil and add 1/2 tablespoon coconut oil to the top of each apple. Bake for another 25 minutes until apples are soft, and filling is bubbling. Serve while warm with coconut cream if desired.

2. Visit an Apple Festival

Many communities host seasonal events like apple festivals for even more hands-on opportunities to engage with fall’s bounty. Taste it for yourself with creamy apple butter, crispy apple fritters, warming apple cider and more, or participate in activities like bobbing for apples and making apple art. Festival hopping is a great way to get together with friends and neighbors while enjoying a glorious, crisp fall day. End the day with a cozy bonfire with a mug of hot apple cider to warm up your hands or extend the fun by preparing a delicious apple-inspired brunch the following morning using the recipe below.

Apple Sheet Pan Pancakes Recipe

Makes 12 servings

sheet pan pancake with apple chips

Ingredients

  • Baking spray
  • 2 cups Bare® Apple Chips
  • 1 1/2 cups oat flour
  • 1 1/2 cups all-purpose flour
  • 4 tablespoons sugar
  • 2 tablespoons baking powder
  • 1 teaspoon ground cinnamon
  • Pinch of salt
  • 2 1/2 cups 1% milk
  • 4 tablespoons canola oil
  • 2 large eggs
  • Syrup and bananas (optional)

Instructions

Preheat oven to 400°F. Spray a 16- x 12-inch baking sheet with baking spray. Whisk together flour, sugar, baking powder, cinnamon, and salt in a medium bowl; add milk, oil, and eggs, whisking until combined. Pour pancake batter into prepared pan, spreading evenly and arrange Bare® Apple Chips evenly over batter. Bake in preheated oven until golden brown, 12 to 15 minutes. Let stand 5 minutes. Cut into squares. Top with syrup and sliced bananas, if desired.

3. Take a Nature Walk

There’s nothing quite as awe-inspiring as the colorful foliage once the leaves begin changing colors. Throw on a comfy sweater and hit the trail to enjoy all that leaf peeping has to offer. These jaunts can range in difficulty, from a casual walk around the neighborhood to climbing new heights where fall foliage can be enjoyed from a unique vantage point. No matter where you go, don’t forget the snacks to enjoy on breaks while you soak in the scenery. Try Bare® Apple Chips, which are baked crunchy, a good source of fiber, and available in several apple flavors, including a cozy Cinnamon Apple flavor. Bare® Apple Chips are an easy, packable option and can be enjoyed on their own or incorporated into an easy, seasonal trail mix!

Open bag of Bare apple chips on a white background.

As the seasons change, embrace the everyday moments during apple season! No matter how you enjoy them, we hope you’ll feel inspired to enjoy apples all season long.

Dedication over the past decade

2024-11-05T10:01:00

(BPT) – For adults who are diagnosed with a lung disease called idiopathic pulmonary fibrosis, long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress), or systemic sclerosis-associated interstitial lung disease, a diagnosis can be life-altering. Marked by scarring of the lungs, these diseases can progressively worsen.

Challenges in Diagnosis

It can take several years for patients to receive a diagnosis of interstitial lung disease (ILD). Symptoms are vague and may lead patients to overlook them or incorrectly attribute them to factors like fitness level or aging. Sylvia Ann, who was diagnosed with a rare form of chronic ILD with lung fibrosis, assumed her symptoms were a result of her lifestyle. “I thought that I just needed to start eating breakfast. I also thought it might be because I was overweight,” she recalls.

Initially misdiagnosed with asthma and sleep apnea, Sylvia Ann’s struggle to pinpoint the cause of her symptoms was frustrating. It took several appointments with her primary care doctor and a series of specialists before she was diagnosed with lymphocytic interstitial pneumonia, a chronic fibrosing ILD with worsening fibrosis.

Tana experienced a similar journey. Around the time of her 60th birthday, she began experiencing symptoms like body aches and cold hands. She initially brushed off her symptoms, and so did her rheumatologist, who diagnosed her with mild osteoarthritis and attributed the disease to aging. But when Tana began experiencing joint stiffness and coughing, she knew it was time to revisit her diagnosis. Her primary care doctor referred her to a pulmonologist, who diagnosed her with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

In 2014, the U.S. Food and Drug Administration (FDA) approved OFEV® (nintedanib) capsules to treat adults with idiopathic pulmonary fibrosis. Since then, OFEV has also received approval to treat adults with long lasting (chronic) interstitial lung disease in which lung fibrosis continue to worsen (progress), and to slow the rate of decline in lung function in adults with SSc-ILD, also known as scleroderma-associated interstitial lung disease. It is not known if OFEV is safe and effective in children.

While a diagnosis can be devastating, both Sylvia Ann and Tana worked with their healthcare providers to develop their treatment plans.

“Despite my current care, my disease was still progressing. So based on my pulmonologist’s assessment of my chronic ILD with lung fibrosis that continued to worsen, he introduced me to OFEV. It’s been a relief for me and my family to have a treatment option for my disease,” says Sylvia Ann.

In addition to their treatment with OFEV, both Sylvia Ann and Tana credit the availability of patient support programs to support them on their journey.

“All of the information that the OPEN DOORS® Patient Support Program provided, coupled with my own research, made me feel empowered,” says Sylvia Ann.

Important Safety Information and Use

What is the most important information I should know about OFEV?

OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.

What should I tell my doctor before using OFEV?

Before you take OFEV, tell your doctor about all of your medical conditions, including if you have:

  • liver problems.
  • heart problems.
  • a history of blood clots.
  • a bleeding problem or a family history of a bleeding problem.
  • had recent surgery in your stomach (abdominal) area.

Tell your doctor if you:

  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
  • are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.

What are the possible side effects of OFEV?

OFEV may cause serious side effects.

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

  • Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.
  • Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
  • Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.
  • Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
  • Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
  • Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
  • Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. 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.

What is OFEV?

OFEV is a prescription medication used:

  • to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
  • to treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  • to slow the rate of decline in lung function with adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).

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

Please click here for full Prescribing Information, including Patient Information.

To learn more about OFEV as a treatment option and patient support services, visit www.OFEV.com.