Category: Brandpoint Health

2022-11-22T13:01:00

(BPT) – With experts predicting a spike in respiratory viruses like COVID-19 and influenza this season, it’s important to know your testing options. Learn about the types of tests available to diagnose these respiratory infections below and visit go.roche.com/respiratoryseason for more information.

2022-11-22T07:01:00

(BPT) – Provided by Merck.

When Colleen was 35, her life was going exactly as she’d planned. She had a management position in a large company that she loved and was thrilled to be expanding her family with her husband after giving birth to her second child.

But shortly after, she noticed something wasn’t right as she became out of breath after little effort or exercise. When she didn’t feel any better a year later, she went to see her doctor about it. And that’s when her medical journey began.

Her primary care doctor initially diagnosed her with asthma, but Colleen found herself getting worse, not better, as the years went by. After two and a half years of escalating asthma and COPD medications, her primary doctor finally referred her to a cardiologist.

After some tests, the cardiologist shared difficult news. He told Colleen she had pulmonary arterial hypertension (PAH), a rare, progressive (worsening over time) disease that often leads to limited physical activity, heart failure and reduced life expectancy due to the heart’s inability to deliver sufficient blood to the lungs. Most people have no known family history of the disease.

“It took so many years and doctors to figure out why I was so sick. When I finally learned it was PAH, I had no idea what it meant,” said Colleen. “I was only 38 when I read that I had only a few years to live. I’ll never forget that. By that point, my oldest was 7 years old and my youngest was 3 years old so I was so worried for them and my husband. It’s now been 15 years since my diagnosis, and I’ve been able to manage it thanks to excellent care. I’m so grateful to be alive.”

While some people with earlier stages of PAH often do not look outwardly sick to others, Colleen wants others to know that having this condition is not easy. The lives of people with PAH may change dramatically due to the physical burden created by PAH. They may also experience financial burdens, unemployment or social isolation.

“As my disease progressed, I had to make lifestyle changes. I couldn’t make it to the sidelines of a baseball field to watch my son play in a game,” said Colleen. “I was truly relegated to living on the sidelines myself. Eventually I had to leave my career to focus on my survival.”

Leaning on a support system of loved ones helped Colleen cope, in addition to working with her doctor. Since her diagnosis, Colleen has dedicated her life to helping people with PAH and raising awareness of the disease.

“Whatever others can do to lift up the community and spread awareness of this devastating disease is appreciated.”

Copyright © 2022 Merck & Co., Inc., Rahway, NJ USA, and its affiliates. All rights reserved.

2022-11-21T07:01:00

(BPT) – A liver cancer diagnosis can be overwhelming. Navigating this complex and often misunderstood disease can be challenging and, like many others before them, the more than 40,000 Americans who will be diagnosed this year may feel stigmatized, lost and alone. Some people living with liver cancer may even feel discouraged or uncomfortable seeking medical care. Ultimately, it’s more important than ever for anyone impacted by liver cancer to be empowered to take action by understanding more about this disease, finding support, and maintaining a healthy lifestyle.

To help raise awareness about liver cancer and the importance of making simple daily adjustments to support liver health, baseball legend and Latin Grammy-nominated musician Bernie Williams teamed up with Blue Faery, the Global Liver Institute and Eisai Inc. to launch One Liver to Love. Through this initiative, anyone living with liver cancer can find information, educational resources and advocacy support services, as well as a sense of community. Check out this video to hear more from Bernie and learn about the four bases of liver health—nutrition, exercise, sleep and mental health—that are key to maintaining a healthy lifestyle with liver disease and liver cancer.

Just like in baseball, Williams also understands the importance of relying on a team for support. Having many family members impacted by liver disease, he knew it was crucial to provide emotional support and help them to maintain healthy lifestyle choices throughout their care. That’s why he joined the One Liver to Love program to help people living with liver cancer feel seen and inspire them to build their own support team roster.

“Liver disease is personal to me. It has impacted my mom, my uncle and my grandfather, and I’ve seen firsthand the difficulties and feelings that come with it,” said Williams. “Liver disease and liver cancer can disproportionately impact communities of color, so I’m glad to go to bat for the One Liver to Love initiative to encourage everyone to be proactive when it comes to liver health and help those affected by liver cancer feel seen and supported.”

“Liver cancer can be thought of as a disease within a disease, because most liver cancers occur in people with an underlying liver condition such as cirrhosis and viral hepatitis,” said Dr. Mark Lewis, MD, director, Gastrointestinal Oncology, Intermountain Healthcare, Salt Lake City, Utah. “The liver is a vital organ, so it’s crucial to focus on overall liver health. People living with liver cancer should turn to their health care team to better understand the disease, ways they can maintain a healthy lifestyle, and find a treatment plan that’s right for them.”

“Life may throw curveballs, but it’s important to remember you’re not alone and that there are steps you can take to be proactive about your liver health,” says Williams. “I hope that by understanding these four bases, turning to family and loved ones, and connecting with the liver cancer community as part of your team, you can feel empowered to cast aside stigma, seek support and hit a ‘home run’ for liver wellness.”

For helpful information, advocacy support and educational resources about liver disease and liver cancer, visit OneLiverToLove.com. You can also join the conversation online by using #OneLiverToLove on social media.

2022-11-18T09:31:00

(BPT) – *Gina is an actual SKYRIZI patient, compensated by AbbVie for sharing her story.

As a Texas native, Gina is no stranger to the scorching temperatures, which for most people means a wardrobe of short-sleeved shirts and shorts. But when Gina experienced a rapid onset of moderate to severe plaque psoriasis—a chronic, inflammatory skin condition that causes itchy, red, flaky and sometimes painful patches known as plaques to appear on the skin—she had no choice but to adjust her wardrobe.

Gina’s psoriasis plaques that covered the majority of her body dictated her style, so she covered them with long pants, boots and shirts that came up to her neck. Working in a high-profile role as a framing superintendent and estimator, where she spent most of her time outside, Gina’s wardrobe was often called into question by her coworkers. “The last thing I wanted was to bring attention to my plaques,” she remembers.

This, combined with the loss of her father, mother and beloved dog all within just over a year’s time, impacted Gina’s life.

“Most days, I would work, come home and sleep,” Gina says. “Especially in the beginning when my plaque psoriasis was getting worse, it was hard to think of much else but the plaques on my skin.”

After nearly a year of receiving advice from her family doctor, Gina knew it was time to see a dermatologist. While initially nervous because of the severity of her symptoms, Gina recalls feeling more comfortable once she met the dermatologist and his team.

“Immediately he was sympathetic and open to talk about everything,” Gina says. “Any question I had, he answered it. He was so open and honest, and always made me feel important and heard.”

Her dermatologist first prescribed topical treatments, but Gina didn’t experience the skin clearance she had hoped. So, she approached her dermatologist hoping to find a treatment plan that would meet her goals. Together, she and her dermatologist decided to try SKYRIZI^® (risankizumab-rzaa), a biologic medicine for moderate to severe plaque psoriasis.

Within a few months, her plaques cleared up almost completely. Gina isn’t the only one who achieved clearer skin with SKYRIZI. In clinical trials, three out of four people achieved 90% clearer skin at four months after just two doses. Of those who achieved 90% clearer skin, nearly 9 out of 10 people sustained 90% clearer skin through one year. Additionally, nearly four out of 10 people achieved 100% clear skin at four months and nearly six out of 10 people achieved it at one year. Individual experiences may vary.

SKYRIZI is administered quarterly with four doses a year after two starter doses.

SKYRIZI may cause serious side effects, including:

• Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any symptoms of a serious allergic reaction.
• Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

Also, tell your doctor if you plan to or recently received a vaccine.

Gina embraced aspects of her life differently by no longer hiding her plaques and letting her condition influence her fashion choices. She even wore a green, ruffle-accented dress that showed off her legs where her plaques used to be and complemented her shoulders to a friend’s wedding.

“I get up and put on what I want to wear,” Gina shares, noting how she felt with people not asking as many uncomfortable questions about her skin. “The plaques on my skin are not the first thing that starts my conversations.”

Looking back, Gina wishes she hadn’t waited so long to see a dermatologist. “For me, seeking a specialist and second opinion was an important part of finding a treatment plan to help me achieve my goals,” she explains.

Preparing questions ahead of time, reading online resources and downloading a doctor discussion guide can also help people prepare to have a proactive conversation with their dermatologist. “Feeling heard is an important consideration when choosing a physician,” she adds. “No one deserves to feel alone or suffer in silence.”

Open and honest conversations with a dermatologist who specializes in treating plaque psoriasis may help people find a management plan that fits their lifestyle. Learn more about SKYRIZI here.

USE for SKYRIZI^® (risankizumab-rzaa)
SKYRIZI is a prescription medicine used to treat adults with:

• moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Important Safety Information

What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?

SKYRIZI is a prescription medicine that may cause serious side effects, including:

Serious allergic reactions:

• Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
• fainting, dizziness, feeling lightheaded (low blood pressure)
• swelling of your face, eyelids, lips, mouth, tongue, or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash, hives
• itching

Infections:

SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

• fever, sweats, or chills
• cough
• shortness of breath
• blood in your mucus (phlegm)
• muscle aches
• warm, red, or painful skin or sores on your body different from your psoriasis
• weight loss
• diarrhea or stomach pain
• burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions,
including if you:

• have any of the conditions or symptoms listed in the section “What is the most important information I should know about SKYRIZI?”
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
• are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
• become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

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

What are the possible side effects of SKYRIZI?

SKYRIZI may cause serious side effects. See “What is the most important information I should know about SKYRIZI?”

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

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

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

Please see the Full Prescribing Information, including the Medication Guide, for SKYRIZI.

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.

If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.

Learn more about SKYRIZI at SKYRIZI.com.

Sponsored by AbbVie.

US-SKZD-220506

2022-11-17T11:01:00

(BPT) – A mystery illness. Decades of unexplained pain and fatigue. A mother’s boundless love. This might seem like a description from a movie, but this is reality for Bryan Bosch who credits his mother’s support for helping him finally get answers about the rare disease disrupting many aspects of his life.

A childhood filled with illness

“Ever since I was little, I was always sick,” said Bryan. His childhood was plagued by illnesses, including a prolonged battle with a highly contagious infection and spending time in and out of hospitals searching for an explanation for Bryan’s poor health. For several years, doctors believed hyperthyroidism was the cause. In the meantime, Bryan struggled with things that his peers took for granted, having trouble holding objects and suffering from extreme tiredness.

“My mom is the first person who noticed something was not right,” said Bryan. “I started dropping stuff, and she said, ‘That’s not normal.’” Faced with these mysterious symptoms and desperate to get answers, Bryan’s mom knew she would have to take charge and advocate on behalf of her son to get him the care he needed. She started by watching him closely and writing down everything she noticed, including how his symptoms and behaviors changed.

The next decade was an incredibly difficult one for Bryan and his mom, as Bryan’s health continued to decline. He suffered from extreme pain and tiredness and experienced a range of symptoms that impacted his ability to study, work or fully live life. For some time, Bryan was unable to work because of his severe fatigue and chronic pain. His right eye drooped and he experienced double vision that prevented him from driving. He struggled with basic functions like chewing, swallowing and even breathing properly.

Throughout this time, Bryan was incorrectly diagnosed with a range of diseases that doctors believed might explain his symptoms. First, doctors thought he had multiple sclerosis (MS). Then he was told he had fibromyalgia. Next, he was diagnosed with ALS, also called Lou Gehrig’s disease, and was told to make end-of-life preparations.

“I was told I had ALS, but I didn’t believe it. It just didn’t make sense. My mom encouraged me to keep going back. She said I needed a new opinion. She would encourage me to [go back to] my specialists and primary doctor. She knew there was something missing,” he said.

Through this difficult period, Bryan’s mother was a constant source of support, assistance and courage, no matter how challenging his health became. With Bryan unable to drive himself, his mother took responsibility for getting him to his appointments. Once there, she helped him explain his symptoms and self-advocate to his health care team.

Thanks to the perseverance of his mom, after seeing seven different neurologists over a decade, Bryan finally got the answers he so urgently needed when he was correctly diagnosed with generalized myasthenia gravis (gMG).

“My mom knows me better than I know myself,” said Bryan. “I am so lucky to have her.”

What is generalized myasthenia gravis (gMG)?

Generalized myasthenia gravis (gMG) is a rare, chronic autoimmune disorder characterized by loss of muscle function and muscle weakness. The disease affects approximately 90,000 adults in the U.S., most commonly beginning for women before the age of 40 and for men after the age of 60.

Myasthenia gravis often begins with weakness in the muscles that control movement of the eyes and the eyelids, with droopy eyelids and double vision. These are some of the earliest symptoms patients experience, along with slurred speech and lack of balance. The disease often progresses into gMG, a more severe and generalized form. At this point, the muscle weakness may spread to the rest of the body and can cause more severe symptoms, including impaired swallowing, choking, extreme fatigue and respiratory failure.

Over three decades, Alexion has spearheaded pioneering research demonstrating the role of the complement system in certain rare diseases, including gMG, leading to innovative treatment advances. The complement system is a part of the immune system and is essential to the body’s defense against infection. But when the system is thrown out of balance, a dangerous, uncontrolled series of reactions occurs, where cells and tissues are attacked, resulting in harmful inflammation and the destruction of healthy cells. In gMG, the complement system can inappropriately cause the immune system to attack the neuromuscular junction (NMJ), a connection point between nerve cells and the muscles they control. Clinical studies conducted by Alexion in patients with gMG have shown that inhibiting the complement system can prevent the body’s attack on the NMJ, reducing damage and helping prevent the breakdown in communication between the brain and muscles.

Bryan’s message for others

No matter the ups and downs of his personal health journey, there was one steadfast positive factor for Bryan: his incredible mom. November is National Family Caregivers Month, a time to recognize and honor the important role caregivers play in helping loved ones manage their health. Being a caregiver can be challenging in many ways, including mentally, physically and financially. But their dedication changes lives, and they deserve the utmost gratitude and appreciation.

Correctly diagnosed at age 35, Bryan is grateful to finally have answers for what he’s been experiencing — and he encourages others in similar situations to keep searching for an accurate diagnosis and lean on their loved ones for support.

“My mom continues to help me and make me a better person,” said Bryan. “She’s pushed me to become more social and I’ve joined my local gMG association to help out. Making connections has helped me in so many ways. My mom is amazing, and I don’t know what I’d do without her.”

Brought to you by Alexion Pharmaceuticals, Inc.

2022-11-17T08:01:00

(BPT) – Article is sponsored and developed by Sanofi

Navigating a rare blood disorder is not easy, but for those with cold agglutinin disease (CAD), there is hope to take back control. Hear about Duffy’s comeback from CAD. The information conveyed in this article is not medical advice.

Throughout her entire life, Duffy has remained very active. Whether it was participating in half marathons, volunteering at her local hospital, or baking for her grandchildren, Duffy was always on the move. One day in November 2017, she began walking up a flight of stairs and started to feel breathless – this is when she knew there was something seriously wrong.

Charting Unknown Territory

Based on her blood tests, her physician thought she may have lymphoma or liver cancer and immediately ordered a battery of tests to try and diagnose the problem. Duffy was concerned and afraid. “I thought doctors had all the answers, so it frightened me that we were in the unknown,” she said.

While waiting for blood test results and hopefully answers, Duffy and her family went on vacation to Utah, where the altitude was 11,000 feet above sea level. To her surprise, she was so cold, and couldn’t breathe and was gasping for air, which was terrifying to her.

Understanding Cold Agglutinin Disease (CAD)

Shortly after that trip, she was diagnosed with cold agglutinin disease (CAD), a rare autoimmune disease in which the body attacks and destroys its own red blood cells (the destruction of red blood cells is called hemolysis).^1,2 Initially, Duffy’s reaction to her diagnosis was one of deep fear. At the time there was little information about this condition available online. She quickly learned that in addition to fatigue and irregular heartbeat, CAD can also cause other symptoms including weakness, shortness of breath, light-headedness, chest pain, and a bluish color or discomfort in the hands and feet.^3,4

Given that CAD is a rare disorder,¹ sometimes hematologists and other physicians may not be aware of this disease and how to treat it. After finding a hematologist who specialized in treating people with CAD, Duffy learned about ENJAYMO® (sutimlimab-jome), a breakthrough treatment that has been proven to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD.⁵

The doctor told Duffy that the most common side effects of ENJAYMO are respiratory tract infection, viral infection, diarrhea, indigestion, cough, joint pain, joint inflammation (arthritis), and swelling of the lower legs, ankles, and feet.⁵ The doctor also explained that she would need at least two hours of monitoring after her first infusion and then at least one hour for subsequent treatments, and that vaccinations against infections caused by certain types of bacteria may be needed before beginning treatment.⁵

At first, Duffy was hesitant to begin the treatment, but after discussing options with her doctor and family members, she realized that for her, the benefits outweighed the cost by trying ENJAYMO. It seemed to her like a viable option that showed real promise. ENJAYMO works by targeting C1s, a component of the first protein in the classical complement pathway, where Duffy’s immune system was going haywire from this disease, and it has shown improvement in hemoglobin levels in clinical trials for some people living with CAD.⁵ Duffy and her doctor filled out an enrollment form to be connected to ENJAYMO Patient Solutions, to access education and support for patients. Her case manager helped her navigate the necessary insurance approvals so she could start taking ENJAYMO.

ENJAYMO’s Role in a CAD Comeback

The CARDINAL clinical study evaluated the safety and efficacy of ENJAYMO in 24 patients with CAD with a history of transfusion during the 6 months prior to starting the study. 54% of the patients taking ENJAYMO (13/24) met all three of the following criteria: increases in levels of hemoglobin (the protein in red blood cells that carries oxygen) from the start of the study (an increase of ≥ 2 g/dL or hemoglobin ≥ 12 g/dL at treatment assessment, from a baseline hemoglobin level of 8.6g/dL), did not receive transfusions from Week 5 until the end of the 6-month study (Average transfusions at baseline: 2 within the last 6 months; 2 within the last 12 months), and had no additional treatment for CAD beyond what was permitted in the study from Week 5 until the end of the study. Of the 54% of patients who met all three criteria, looking at each criteria separately, 63% of patients (15/24) had increases in hemoglobin levels from the start of the study (an increase of ≥ 2 g/dL or hemoglobin ≥ 12 g/dL at treatment assessment), 71% (17/24) did not receive transfusions from Week 5 until the end of the 6-month study, and 92% (22/24) had no additional treatment for CAD beyond what was permitted in the study. Patient experiences on ENJAYMO may vary so please talk to your doctor when making treatment decisions. To learn more about ENJAYMO and clinical trial data results, please visit ENJAYMO.com.

Charting Duffy’s CAD Comeback

Duffy considers the day she made the decision to begin ENJAYMO as one of great celebration and the beginning of her comeback from CAD. She started receiving ENJAYMO infusions at her doctor’s office, and now Duffy is able to receive infusions at home from a visiting nurse to make her treatment more convenient.

With ongoing ENJAYMO treatment every two weeks, she is now able to continue being active with her hemolysis better managed.⁵ Since starting ENJAYMO, Duffy’s hemoglobin numbers increased within a few weeks,⁵ which has positively impacted her anemia. She can focus more on her family, volunteering, and hobbies she had previously paused due to her diagnosis. She is now an advocate for the CAD patient community and encourages others to be their own advocates when it comes to managing CAD.

INDICATION

ENJAYMO is a prescription medicine used to decrease the need for red blood cell transfusion due to the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD).

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

IMPORTANT SAFETY INFORMATION

Do not receive ENJAYMO if you are allergic to sutimlimab-jome or any of the ingredients in ENJAYMO.

ENJAYMO can cause serious side effects, including:

• Serious Infections: ENJAYMO is a prescription medicine that affects a part of your immune system. ENJAYMO can lower the ability of your immune system to fight infections. People who take ENJAYMO may have an increased risk of getting infections caused by certain kinds of bacteria such as Neisseria meningitides, Streptococcus pneumoniae, and Haemophilus influenzae. These infections may be serious or life-threatening. Some infections may quickly become life-threatening or cause death if not recognized and treated early.
• You need to receive vaccinations against infections caused by certain kinds of bacteria at least 2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during treatment
• If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
• Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call your healthcare provider or get medical help right away if you get any new signs and symptoms of an infection, including:
• fever
• severe headache with stiff
  neck or back
• pain during urination or urinating
  more often than usual
• cough or difficulty breathing
• flu-like symptoms
• pain, redness or
  swelling of the skin
• Infusion-related reactions: Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction, and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including:
• shortness of breath
• rapid heartbeat
• nausea
• flushing
• headache
• Risk of autoimmune disease: ENJAYMO may increase your risk for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including:
• joint pain or swelling
• rash on the cheeks and nose
• unexplained fever
• If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you closely for return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD to return. Symptoms or problems that can happen due to red blood cell breakdown include:
• tiredness
• shortness of breath
• rapid heart rate
• blood in your urine or dark urine

The most common side effects of ENJAYMO include:

• respiratory tract infection
• viral infection
• diarrhea
• indigestion
• cough
• joint pain
• joint inflammation (arthritis)
• swelling of the lower legs, ankles, and feet

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

Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:

• have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
• are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ENJAYMO passes into your breast milk.

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

Please see Full Prescribing Information, including Medication Guide.

References

1. Collie J C. Cold agglutinin disease. Practice Essentials, Pathophysiology, Etiology. Medscape. February 7, 2022. Accessed September 20, 2022. https://emedicine.medscape.com/article/135327-overview
2. Mullins M, Jiang X, Bylsma LC, et al. Cold agglutinin disease burden: a longitudinal analysis of anemia, medications, transfusions, and health care utilization. Blood Adv. 2017;1(13):839-848. Published 2017 May 19. doi:10.1182/bloodadvances.2017004390
3. Badireddy M, Baradhi KM. Chronic Anemia. StatPearls. StatPearls Publishing; 2022.
4. Das S, Maiti A. Acrocyanosis: an overview. Indian J Dermatol. 2013;58(6):417-420. doi:10.4103/0019-5154.119946
5. Enjamyo (sutimlimab-jome) [package insert]. Sanofi; 2022.

MAT-US-2207482-v1.0-10/2022

© 2022 Genzyme Corporation. All rights reserved.

ENJAYMO and Sanofi are trademarks of Sanofi or an affiliate.

2022-11-16T08:01:00

(BPT) – Did you know coughing is one of the most common reasons to visit a doctor? For those who have a persistent cough, including the estimated 12 million adults in the U.S. who live with chronic cough (a cough lasting longer than eight weeks), it can be difficult to explain to your health care provider how often you cough and how it may affect your daily life. Fortunately, there is an app powered by artificial intelligence (AI) to help people monitor their cough trends.

Merck has partnered with Hyfe, the global leader in AI-powered cough detection, to launch CoughTracker as part of The Cough Chronicles, an educational resource for people living with chronic cough sponsored by Merck in collaboration with the American Lung Association, the Asthma and Allergy Foundation of America and the Allergy & Asthma Network.

CoughTracker is a free, easy-to-use, healthy living app that can help track and visualize the number of times you cough over a certain time period. When used daily, it can provide you with details about your cough patterns and help uncover triggers of your cough that you might not have noticed before. You can use this information to talk with your health care provider about how often you cough or how it’s affecting your life.

“We often hear from people with a persistent cough that it can be challenging to manage their condition on their own. We are excited that CoughTracker may help provide information about one’s cough frequency and facilitate a conversation between patients and their health care providers,” said Bev Stewart, National Senior Director of Health Promotions at the American Lung Association.

Using CoughTracker is easy. You can choose when the app listens for your cough, capturing the sound of each cough and allowing you to review them. CoughTracker identifies the sounds that might be coughs. These sounds are then analyzed and once confirmed as coughs through AI technology, they are recorded on your own dashboard. You can see how many times you cough and when your cough is occurring.

When the app is running, every time there is a cough-like sound the app records a very short sample — only half a second to determine if the sound is a cough. You can pause or stop CoughTracker from recording your cough at any time. CoughTracker also allows you to set a reminder to turn the app on at certain times of the day, like at your usual bedtime, so you can track your cough while sleeping.

If you have a persistent cough, download CoughTracker by visiting TheCoughChronicles.com, so you can start collecting more information about your cough. CoughTracker, powered by Hyfe with funding and support by Merck & Co., Inc., should not be used to diagnose or treat any health conditions.

2022-11-15T08:01:00

(BPT) – Narcolepsy is often dismissed as a minor sleep issue, but in reality, it’s a serious, chronic sleep disorder that can negatively impact overall health and increases odds of having heart disease, diabetes, obesity, high blood pressure and a stroke. What’s more, a study that compared 9,312 adults with narcolepsy to 46,559 similar adults who do not live with the sleep disorder showed that people with narcolepsy have 1.6x greater odds of having a heart attack.

Since studies show narcolepsy is associated with higher rates of heart diseases, people with narcolepsy should work with their doctor to establish an overall health plan, which may include strategies to limit the impact of cardiovascular risk factors.

“Making heart-healthy choices is critical for people with narcolepsy due to their increased risk for cardiovascular problems,” said Rick Bogan, MD, FCCP, FAASM, founder of Bogan Sleep Consultants and associate clinical professor at University of South Carolina School of Medicine. “Lifestyle adjustments like watching salt intake, not smoking and exercising can play an important role in helping people with narcolepsy better manage their cardiovascular health.”

Narcolepsy is a debilitating neurological disorder characterized by the inability to regulate sleep-wake cycles normally, affecting an estimated one in 2,000 people in the U.S. Everyone with narcolepsy has excessive daytime sleepiness symptoms, meaning they are overly tired during the day, regardless of how much they slept the night before. Of those affected by narcolepsy, about 70% are believed to have cataplexy, which is a sudden, brief loss of muscle control triggered by strong emotions like embarrassment, laughter, surprise or anger.

When it comes to risk factors for cardiovascular issues among patients with narcolepsy, Dr. Bogan emphasizes the importance of lifestyle changes, such as watching salt consumption. Many people know that sodium intake is important but may not be aware of its connection to heart health. For the general population, the American Heart Association recommends an ideal limit of 1,500 mg of sodium a day for most adults, but a study from the Centers for Disease Control and Prevention found Americans 2 and older consume an average of 3,409 mg of sodium a day. For most adults, lowering sodium intake by 1,000 mg per day can help reduce the risk for high blood pressure, heart disease and stroke. For patients with narcolepsy, healthy eating and food preparation can help them consume less salt, but many patients don’t realize that some medications may also contain significant amounts of sodium.

Xyrem (sodium oxybate) oral solution is approved to treat people 7 years or older with narcolepsy who have excessive daytime sleepiness and cataplexy; however, this high-sodium oxybate can contain more than the recommended daily amount of sodium. This high-sodium oxybate can contain as much as 1,640 mg of sodium per day at the maximum recommended nightly dose of 9 grams. At the recommended maximum dose, that’s more sodium than four orders of large fries (based on an average of 380 mg of sodium per one large serving), which can contain approximately 1,520 mg of sodium according to a 2012 USDA analysis of three fast food chains.

With 92% less sodium than high-sodium oxybate, XYWAV (calcium, magnesium, potassium, and sodium oxybates) oral solution is the first and only lower-sodium oxybate treatment approved by the U.S. Food and Drug Administration for people seven years or older to treat excessive daytime sleepiness and cataplexy in narcolepsy. Collaborate with your doctor to determine a customized plan to help manage your narcolepsy symptoms and overall health.

XYWAV may cause serious side effects including Central Nervous System (CNS) depression, abuse and misuse, breathing problems, mental health problems and sleepwalking. Because of the risk of CNS depression, abuse and misuse, XYWAV is available only by prescription, and filled through the central pharmacy in the XYWAV and XYREM REMS. Please see below for more Important Safety Information on XYWAV.

To learn more about XYWAV, a lower-sodium oxybate, as a treatment for narcolepsy symptoms of excessive daytime sleepiness and cataplexy, visit XYWAV.com/narcolepsy.

About Xywav^® (calcium, magnesium, potassium, and sodium oxybates) oral solution
Xywav is a lower-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. FDA recognized seven years of Orphan Drug Exclusivity for Xywav in June 2021 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at FDA found Xywav to be clinically superior to Xyrem by means of greater cardiovascular safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. According to FDA, these differences in sodium content will be clinically meaningful in reducing cardiovascular disease for many people with narcolepsy who suffer from EDS and/or cataplexy. There are no head-to-head data for Xywav and Xyrem. Xywav is comprised of a unique composition of cations resulting in 92% less sodium. At the recommended dosage range of 6 to 9 grams, that is a reduction of approximately 1,000 to 1,500 mg of sodium per night. While the exact mechanism of action of Xywav is unknown, it is hypothesized that the therapeutic effects of Xywav on cataplexy and excessive daytime sleepiness are thought to work during sleep to help with symptoms during the day. Because of the risks of CNS depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.

Important Safety Information

WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you or your child has any of these serious side effects.

Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child’s prescription for XYWAV filled.

Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.

Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.

XYWAV can cause serious side effects, including the following:

• Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
• Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
• Sleepwalking. Sleepwalking can cause injuries. Call your doctor if this occurs.

The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleep walking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.

The most common side effects of XYREM (which also contains oxybate like XYWAV) in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.

XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.

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 full Prescribing Information, including BOXED Warning, and Medication Guide here: https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf.

2022-11-15T08:01:00

(BPT) – The holidays are fast approaching. From Thanksgiving turkey to other holiday comfort foods, this time of year is synonymous with eating, which can present challenges for some children living with chronic GI issues. While festive treats can upset all tummies, children with conditions such as celiac disease, gastroesophageal reflux disease, eosinophilic esophagitis (EoE), and food allergies may be particularly vulnerable. Not to mention, the stress and changes to a routine during the holidays can sometimes make GI symptoms much worse. At-risk children and young adults may also be due for their routine endoscopic monitoring at this time of year, which can add to their worry, as well as their parents’.

What can parents do to help their children’s GI issues during the holiday season?

This is the time of year when you most want your child’s GI system healthy, so there are steps you can take to enjoy a fun and comfortable holiday season.

• Be aware of trigger foods – Certain foods can exacerbate GI issues, and it’s no secret that the holidays tend to focus on particularly rich, high-fat foods that can make symptoms worse for children with GI issues. Do your best to keep your kids away from the worst offenders: the foods that you know have made them sick in the past. You can also think about ways of making your children’s favorite foods more gut-friendly. For example, if your child is living with celiac disease, look up a few gluten-free recipes that incorporate cinnamon, peppermint, and nutmeg, so your child can continue to taste the flavors of the season.
• Fiber, fiber, fiber – Holiday cookies and cakes lack fiber and are high in sugar and fats. Fiber is an essential nutrient to keep your child’s gut healthy and their system regular. While you can’t expect kids to eat bran flakes in place of desserts, it’s important to make sure they get enough fiber throughout the day in anticipation of holiday gatherings. Pancakes made from ingredients like buckwheat and muffins that contain bran are great options. Even sprinkling their favorite granola over yogurt and fruit can help them add more fiber to their diet. Remember to increase your child’s water intake when you increase fiber to avoid constipation.
• Encourage children to pace themselves – Eating fast can slow down digestion and lead to constipation and stomach pain. Try to encourage your kids to pace themselves; tell them to try to set their forks down in between bites and courses at the holiday table. This will also help them with portion control.
• Talk to your provider about the option of endoscopy of the upper GI tract without sedation – For children with chronic GI issues, more frequent endoscopies may be the standard of care to monitor specific conditions. If your child has a chronic GI condition that requires routine monitoring via endoscopy, you know it is often inconvenient and stressful. Moreover, anesthesia for children may be associated with additional fear and potential risks. It is important for parents to talk to their child’s healthcare team because there are other options.

Some providers now have the option to offer the use of the EvoEndo Single-Use Endoscopy System as an alternative for patients five and older to undergo a transnasal endoscopy (TNE) upper gastrointestinal exam with biopsies. TNE avoids the need for any needles, sedation, or anesthesia, and the provider may choose to offer virtual reality distraction to enhance the patient experience. This may be more convenient and less stressful during this hectic time of year. Compared to traditional endoscopy, studies have shown children prefer TNE over their prior sedated endoscopy (Scherer et al.). Further, unsedated TNE of the upper gastrointestinal tract is associated with less time in the hospital and shorter recovery time (Nguyen et al.). Without general anesthesia or sedation, patients can return to school, work, or other fun holiday activities on the same day as their unsedated TNE.

To learn more about how to manage your children’s GI issues during the holidays and all year round, remember to speak with their healthcare providers. To learn more about the EvoEndo System, visit https://www.evoendo.com/patients. US: RX only. For use by trained physicians only.