Updated Treatment Recommendations for Restless Legs Syndrome (RLS)

2024-11-05T07:01:00

(BPT) – Jim, an 81-year-old former lawyer who lives in Sarasota, Florida, was in Aruba on vacation in the late 1970s when he first experienced an uncomfortable feeling in his legs, almost like shocks.

“It was an alarming sensation, and I had no clue what it was at the time,” Jim said.

It took decades for Jim to be diagnosed with Restless Legs Syndrome (RLS), a sleep-related movement disorder characterized by an urge to move one or both legs, which may be relieved by movement and is most prominent at night.i

RLS can cause an irresistible urge to move one’s legs, a feeling of anticipation and often disrupts the ability to get a good night’s sleep. Clinically significant RLS impacts 2-3 percent of adults in the United States.ii

“From my experience treating patients diagnosed with RLS, their complaints are severe sleep disturbance, daytime fatigue, and mood changes, which can dramatically impair quality of life,” states John Winkelman, M.D., Ph.D., chief of the Sleep Disorders Clinical Research Program in the Department of Psychiatry at Massachusetts General Hospital.

Thirty years after his initial symptoms, following countless visits to the doctor’s office, and trying different medications that didn’t work but instead caused bothersome side effects, Jim was diagnosed with RLS by a sleep medicine physician.

Jim tried several treatment regimens before he was prescribed one which included Horizant® (gabapentin enacarbil) that made his symptoms better.* His constant need to get up and move and stretch throughout the night is now behind him.** Gabapentin enacarbil (Horizant®) extended-release tablets are indicated for the treatment of moderate-to-severe primary RLS in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night.iii

American Academy of Sleep Medicine (AASM) updates its Clinical Practice Guidelines for RLS

For the first time since 2012, the American Academy of Sleep Medicine (AASM) issued an update to its Clinical Practice Guidelines for the treatment of RLS, which provide physicians with recommended treatment options based on a review of the latest clinical research. Dopamine agonists (DAs) have been widely used for the treatment of RLS for 20 years. AASM Clinical Practice Guidelines now suggest against the standard use of DAs due to the risk of augmentation (a gradual worsening of RLS symptom intensity and duration) of RLS symptoms.iv

“Increasing clinical research has demonstrated that dopamine agonists are often associated with a long-term overall worsening of RLS symptoms and are no longer recommended,” Winkelman said. “Gabapentin, gabapentin enacarbil, pregabalin and iron treatment are strongly recommended for the treatment of RLS and it’s important that everyone — physicians and patients — are aware of these changes.”

Gabapentin enacarbil (Horizant®) is the only strongly recommended FDA-approved RLS treatment providing clinically significant improvement in all three of these key domains: RLS disease severity, sleep quality, and quality of life.iv

The importance of talking to a physician about treatment options

It’s important for doctors and people diagnosed suffering from RLS to be aware of these updated guidelines for this widely used class of drugs. Those taking dopamine agonists should speak with their doctor about their current treatment plan.

Visit horizant.com to learn more.**

Jim can now sleep soundly without the need to get up and stretch thanks to his current treatment regimen. Those with RLS who are not finding relief from their current regimen should speak with their doctor to discuss their treatment plan.

* The most common adverse reactions for patients with RLS (incidence >10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness.

**Strong recommendation, moderate certainty of evidence; based on 8 randomized controlled trials and 3 observational studies.

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

HORIZANT® (gabapentin enacarbil) is a prescription medicine used to:

  • treat adults with moderate to severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night.
  • manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.

IMPORTANT SAFETY INFORMATION

  • Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities.
  • Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse.
  • HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
    • thoughts or actions about suicide, self-harm, or dying; attempt to commit suicide
    • new or worsening depression or anxiety; or feeling agitated
    • new or worse restlessness or panic attacks
    • new or worse trouble sleeping (insomnia); or irritability
    • acting aggressive, being angry, or violent; acting on dangerous impulses
    • an extreme increase in activity or talking (mania); other unusual changes in mood or behavior
  • Serious breathing problems. Serious breathing problems can occur when HORIZANT is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting HORIZANT or when the dose is increased. Get help right away if breathing problems occur.
  • Do not stop taking HORIZANT without first talking to your healthcare provider. Suicidal thoughts or actions can be caused by things other than medicines. If you have these thoughts or actions, your healthcare provider may check for other causes.
  • HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms: skin rash, hives, fever, swollen glands that do not go away, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, unexpected severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT.
  • HORIZANT is not the same medicine as gabapentin [for example, NEURONTIN® (gabapentin) and GRALISE® (gabapentin)]. HORIZANT should not be used in their place. Do not take these or other gabapentin products while taking HORIZANT.
  • Before taking HORIZANT, tell your healthcare provider if you:
    • have or have had kidney problems or are on hemodialysis
    • have or have had depression, mood problems, or suicidal thoughts or behavior
    • have or have had seizures
    • have a history of drug abuse
    • have any other medical conditions
    • are pregnant or plan to become pregnant. It is not known if HORIZANT will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant while taking HORIZANT. You and your healthcare provider will decide if you should take HORIZANT while you are pregnant
    • are breastfeeding or plan to breastfeed. Your body turns HORIZANT into another drug (gabapentin) that passes into your milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take HORIZANT or breastfeed
    • drink alcohol
  • Do not drink alcohol while taking HORIZANT because it may increase the risk of side effects.
  • Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking HORIZANT with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
  • Do not stop taking HORIZANT without talking to your healthcare provider first. If you stop taking HORIZANT suddenly, you may develop side effects.
  • The most common side effects of HORIZANT include dizziness, sleepiness, and headache. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of HORIZANT. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report side effects of prescription drugs by contacting Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

For more information, ask your healthcare provider or pharmacist, or consult the full Prescribing Information [Horizant.com].


[i] Allen RP, Picchietti DL, Garcia-Borreguero D, et al. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria–history, rationale, description, and significance. Sleep Med. 2014;15(8):860-73.

[ii] Allen RP, Walters AS, Montplaisir J, et al. Restless Legs Syndrome Prevalence and Impact. Archives of Internal Medicine. 2005;165(11):1286.

[iii] Horizant [package insert] Woburn, MA: Azurity Pharmaceuticals, Inc.; 2022

[iv] Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Published online September 26, 2024. doi:10.5664/jcsm.11390

How this award-winning TV host is setting the stage to help protect her health

2024-11-05T06:01:00

(BPT) – Award-winning TV host, comedian, actress and author Sherri Shepherd is at increased risk for pneumococcal pneumonia and invasive pneumococcal disease (IPD) because she has diabetes. She doesn’t want to let it stop her from taking her shot on — or off — the stage. That’s why Sherri is partnering with Pfizer to share her diabetes story and help raise awareness about the importance of getting vaccinated.

Q: Sherri, there’s no doubt that you’re a superstar in more than one arena. What has helped contribute to your success over the years?

Sherri: I learned early on that you need to run toward the thing that scares you because that’s where you can really thrive. And let me tell you, starting out in comedy and TV can be scary. But I put in the time practicing jokes on the bus, spending time on the road, working late hours behind the scenes, and it all led me to where I was supposed to be. And now, I get to take my shot at doing what I love every day.

Q: I’m sure you faced some challenges to get where you are today. What was one of the biggest you’ve faced?

Sherri: I think the biggest one for me is more of a personal one. I have diabetes, so over the years I’ve had to learn how to keep my health in check. For me, I prioritize eating right, keeping active, talking with my doctor regularly, and getting vaccinated to help prevent pneumococcal pneumonia and IPD. It took a lot to get here so I don’t want to be held back from doing what I love.

Q: Tell me more about pneumococcal pneumonia and IPD. Are they serious?

Sherri: Absolutely. Pneumococcal pneumonia is a potentially serious bacterial lung disease that can disrupt your life for weeks. In more severe cases, it can put you in the hospital and even be life-threatening. The same bacteria that cause pneumococcal pneumonia can also cause invasive pneumococcal disease, or IPD, which includes blood infection and meningitis.

Q: That does sound serious. Who is at greater risk?

Sherri: People like me who are 19 or older with certain underlying medical conditions like diabetes, asthma or COPD. In fact, people 19-64 living with diabetes are at over 5x higher risk for pneumococcal pneumonia and up to 4.8x higher risk for IPD, compared with healthy adults the same age. People 65 or older are also at increased risk, even if they’re healthy.

Q: What advice would you give to people about protecting themselves against pneumococcal pneumonia and IPD?

Sherri: Getting vaccinated is one of the best ways to help protect yourself. And vaccination is available all year round, so I encourage everyone to talk to their doctor or pharmacist to see if a pneumococcal vaccination is right for them. They can also visit VaxAssist.com to book an appointment online today.

Q: Thanks, Sherri. Is there anything else people should know about pneumococcal pneumonia and IPD?

Sherri: People assume you can only get pneumococcal pneumonia and IPD during flu season or in the winter, but you can get it any time of year. And even if you’ve already been vaccinated against pneumococcal pneumonia before, your doctor may still recommend another vaccination for further protection. I love hosting my show and doing comedy, but I don’t joke around when it comes to pneumococcal pneumonia and IPD — and you shouldn’t either. Go talk to your doctor or pharmacist about getting vaccinated, so you can also keep taking your shot at whatever it is you love to do.

Brought to you by Pfizer.

Workplace Wellness: An RD’s Top Five Ways to Maintain Wellness at the Office this Cold and Flu Season

2024-11-04T08:17:00

(BPT) – As the chill of autumn settles in, it brings more with it than just crunchy, colorful leaves and seasonally-inspired drinks. The onset of cold and flu season has officially arrived. Coupled with widespread back-to-office mandates, cold and flu season poses a unique challenge for professionals in office spaces that can quickly become a hotbed for germs and illnesses.

To stay healthy and productive throughout the changing seasons, we spoke with Registered Dietitian Kelly Springer about her top five ways to turn your workspace into a wellness haven to protect yourself and contribute to a healthier, more resilient workplace for all this cold and flu season. To stay at your best, she suggests the following for a holistic approach to workplace wellness:

Wedderspoon  Manuka Honey and lemon and Manuka Honey drops on a kitchen counter top next to lemons and a honeycomb.

Stock Your Desk with Wedderspoon Manuka Honey Throat Drops: Your Secret Weapon

When it comes to maintaining wellness during the cold and flu season, Wedderspoon’s Manuka Honey Throat Drops are a game-changer. These natural lozenges offer soothing relief and are a powerful ally in your wellness routine. Not only do they taste good — coming in a wide variety of flavors including my personal favorite, lemon — but they also feature naturally-occurring wellness ingredients like organic Manuka honey, echinacea and bee propolis to really take it to another level. They provide immediate comfort for scratchy, irritated throats — which is often the first sign of an oncoming illness — while also bolstering your immune system to give you an extra edge against seasonal threats. Rich in antioxidants, they help combat oxidative stress and support overall health. Keeping these in your desk, briefcase or purse is the tastiest way to make sure you’re always prepared should you feel that first tickle in your throat.

Bowl of fruit and nuts including: Apricots, cashues, cranberries, pecan and walnuts.

Build an Immune-Boosting Snack Arsenal

Your immune system is your body’s first line of defense against seasonal illnesses. Fueling it with the right nutrients can make all the difference, which can be hard to do during long and busy work days. Keeping a personal stash of a variety of immune-boosting snacks can be a great way to combat this and also keep your defenses strong throughout the day. Reach for things like:

  • Mixed nuts, which are rich in vitamin E and healthy fats to provide sustained energy throughout the day.
  • Dried fruits, like cranberries, apricots and goji berries, that are packed with vitamin C and help combat free radicals in the body.
  • Pumpkin seeds, a fun, seasonal treat high in zinc for increased immune function.
  • Warm green tea, which is rich in antioxidants and provides comforting relief to irritated throats.
Mini humidifier sitting by a laptop on a desk at home.

Create a Happy Environment

When it comes to fortifying your workspace against cold weather and flu season, creating a clean, comfortable environment with air you can breathe easily is paramount. A must-have in your workplace wellness arsenal is a humidifier, which combats dry indoor air that can irritate your respiratory system, make you more susceptible to illness and lead to chapped, cracked skin. Today, there are so many portable options perfect for an office space to maintain your personal optimal humidity levels to show your lungs, sinuses and skin some love without being overwhelming.

It goes without saying, but regularly cleaning your workspace is essential for maintaining a germ-free environment. To prevent a buildup of germs that can compromise your immune system, make it a habit to sanitize high-touch surfaces in your office like your mouse, keyboard, phone and desktop with natural, non-toxic cleaning products that are powerful against seasonal threats but avoid harsh chemicals.

Together, these routines help create a healthier, happier space that supports your well-being throughout the winter months.

Jelly jar cups with cucumber and lemon water in a tray on a counter top.

Hydrate, Hydrate, Hydrate

Proper hydration is key to maintaining overall health, but is especially important during cold and flu season. When you’re well-hydrated, your body can efficiently flush out toxins and keep your immune system functioning optimally. To make sure you’re getting your ounces in during the day, turn your desk into a hydration station. I find that a large, reusable water bottle with time markers helps me turn my hydration into a game that encourages me to drink at least 64 ounces of water daily. If plain water is just not your jam, you can also take this a step further by having natural flavor enhancers on hand. Lemon or orange slices, cucumber rounds and fresh mint leaves are some of my favorite ways to make drinking water more enjoyable, and they each have their own added benefits and nutrients.

Woman in exercise clothes on a treadmill.

Get Creative About Getting In Your Daily Movement

Regular movement boosts circulation and supports overall health and immune function, but it can be hard to find the motivation to get outside for exercise after a long day at the office — especially as the days grow shorter. When it comes to maintaining your health and wellness during the colder months, a walking pad can be a real game-changer for your office setup. It combats the sedentary desk-work lifestyle, offers the flexibility to multitask throughout your day and helps you to stay active, ensuring you get those steps in without having to brave the early sunset or dreary weather.

By creating a daily office routine focused on these elements, you’ll be implementing a robust defense against cold and flu season. This year, if you look around and everyone seems to be coming down with something, try creating an office space that takes a holistic approach to maintaining your health and wellness.

Nationwide Epilepsy Clinical Trial Investigates Potential New Treatment

2024-11-04T04:01:00

(BPT) – There is a new study evaluating a promising potential new treatment for epilepsy called Rise. Clinics across the nation are currently seeking to enroll participants in this study between the ages of 18-75 who have been diagnosed with focal (partial) onset epilepsy and have experienced resistance to existing treatments.

Epilepsy is a chronic brain disorder that affects over 50 million people worldwide.1 It is characterized by recurrent, unprovoked seizures, which can vary in intensity and frequency.1 Despite numerous treatment options, about 40% of people with epilepsy do not achieve seizure control with current medications.2 During National Epilepsy Awareness Month this November, we are highlighting the urgent need for new effective treatments.

Challenges of Living with Epilepsy

Living with epilepsy can be incredibly challenging. The unpredictable nature of seizures can make daily activities, such as driving, working, or even socializing, difficult and stressful.3 For many, the fear of a sudden seizure looms, impacting their quality of life. In addition to physical challenges, epilepsy can also bring about emotional and psychological burdens, such as anxiety, depression, and social isolation.1

Hope on the Horizon

“Hearing about new clinical trials makes me feel hopeful. The epilepsy community needs a treatment option that helps control seizures with a favorable safety profile,” said Ilene Asuncion, who has been managing epilepsy for years. “A new treatment option would feel like a light at the end of a long tunnel, and I’m optimistic that this research could make a real difference in our lives.”

Enrollment Information

The clinical trial is currently enrolling patients at sites across the United States. If you or someone you know is struggling with epilepsy and is interested in participating in the trial, please visit epilepsyresearchstudy.com for more information. Eligibility criteria for participating in the trial include individuals who:

  • Are between the ages of 18 to 75
  • Have been diagnosed with focal (partial) onset epilepsy for at least one year
  • Have been unsuccessful with at least two anti-seizure medications (ASMs) and are currently on a stable dose of one to three ASMs
  • Have at least four or more observable focal seizures every 28 days

The Rise clinical trial represents a significant step forward in the search for more effective epilepsy treatments. By participating, patients not only have the potential to possibly benefit from a new investigational therapy but also contribute to crucial research that could improve the lives of countless others in the future.

References:

  1. World Health Organization. Epilepsy. Available at https://www.who.int/news-room/fact-sheets/detail/epilepsy. Accessed August 6, 2024.
  2. Ioannou P, Foster DL, Sander JW, et al. The burden of epilepsy and unmet need in people with focal seizures. Brain Behav. 2022;12(9):e2589. doi:10.1002/brb3.2589.
  3. Epilepsy Foundation. Social Concerns. Available https://www.epilepsy.com/complications-risks/social-concerns#:~:text=Having%20seizures%20may%20make%20it,problems%20for%20so%20many%20people!. Accessed August 6, 2024.

Help protect yourself against pneumococcal pneumonia and invasive pneumococcal disease this National Diabetes Month

2024-11-02T06:01:00

(BPT) – In the United States alone, about 38.4 million people have diabetes. That’s about 11.6% of the population. November is National Diabetes Month, which serves as an important reminder to not only rally around those affected by this disease, but also take steps in our own lives to help manage it. It’s the perfect time to provide extra support to loved ones who have this disease and, if you have diabetes yourself, implement healthy lifestyle habits to stay on track of your health goals.

Here are our top tips:

  • Eat balanced meals: Understanding which foods affect your blood sugar levels can help you properly plan your meals.
  • Exercise: Moving your body can help lower your blood sugar levels, so work with your doctor to come up with an exercise routine that works for you.
  • Prevent illness: Being sick can raise your blood sugar levels. That’s why it’s important to avoid illness if possible and create a plan with your doctor for what to do if you do get sick.
  • Get vaccinated against pneumococcal pneumonia and invasive pneumococcal disease (IPD): Know your risk and help protect yourself.

It’s important to know that having diabetes can put you at increased risk for illnesses like pneumococcal pneumonia and IPD. Pneumococcal pneumonia is a potentially serious bacterial lung disease that can disrupt your life for weeks, put you in the hospital and even be life-threatening. The same bacteria that cause pneumococcal pneumonia are also responsible for invasive pneumococcal disease, or IPD, which includes blood infection and meningitis.

How do you know if you’re at risk? If you’re 19 or older with certain underlying medical conditions like diabetes, asthma, chronic heart disease and COPD, you’re at increased risk for both of these diseases. In fact, people aged 19-64 living with diabetes are at over 5x higher risk for pneumococcal pneumonia and up to 4.8x higher risk for IPD, compared with healthy adults the same age. Adults 65 or older are also at increased risk, even if they’re healthy.

If you fit in any of these groups, getting vaccinated is one of the best ways to help protect yourself.

There’s a misconception that you can only get pneumococcal pneumonia and IPD during flu season or in the winter, but you can get it any time of year. Vaccination is available all year round, so now is a great time to assess if pneumococcal vaccination is right for you.

Even if you’ve already been vaccinated against pneumococcal pneumonia previously, your healthcare provider may recommend another vaccination for additional protection.

If you have diabetes, take the time this month to assess how you’re managing it and make sure you’re helping protect yourself. Not sure where to start? Talk to your doctor or pharmacist about pneumococcal vaccination and visit VaxAssist.com to schedule a vaccination appointment today.

Brought to you by Pfizer.

Tara’s journey: Navigating life as a young adult living with narcolepsy

2024-11-01T08:15:00

(BPT) – When she was a full-time college student, Tara was also pretty busy with two part-time jobs working in healthcare, being a dog mom, and spending time with her two nephews and her niece. Her schedule was jam-packed. Tara described feeling like she was “tired all the time” and just wanted to sleep. “It would be so hard to get up and go to work and stay awake at work,” she shared. Tara didn’t know at the time, but she was experiencing a symptom of narcolepsy called excessive daytime sleepiness (EDS).

Narcolepsy is a rare neurological disorder that affects approximately 170,000 people living in the United States. All people living with narcolepsy have EDS, which is defined as the inability to stay awake and alert during the day or the persistent feeling of tiredness. Tara’s relationships with friends and family, daily life, and work were all impacted by EDS. “There’s unfortunately a societal misconception that people living with narcolepsy lack motivation to do things, are lazy, or are depressed,” noted Ellen Wermter, FNP-BC, a sleep medicine specialist at Restorative Sleep Medicine in Charlottesville, VA. For Tara, she shared, “Simple things like cooking, showering, hanging out with friends—they were all impacted by the excessive daytime sleepiness. I dreaded doing almost anything. I just wanted to sleep.”

In addition to excessive daytime sleepiness, Tara would often drop things or randomly fall. She dismissed these signs, thinking she was just being clumsy, but she was actually experiencing another narcolepsy symptom called cataplexy. Cataplexy is defined as the sudden onset of weak or paralyzed muscles, usually brought on by strong emotions or certain situations. It can cause the person’s knees to buckle or collapse completely; but more often it affects specific areas of the body such as the hands or eyelids. Wermter noted, “In my experience, many people may not realize that what they are experiencing is cataplexy and that it is related to their narcolepsy.”

When Tara first received her diagnosis of narcolepsy with cataplexy, part of her was relieved knowing it “actually was something and wasn’t just in [her] head.” With that sense of relief, Tara also felt a little nervous not knowing what was next.

Searching for a treatment

Smiling Tara wearing a coat and hugging her dog while standing in a field.


Tara first learned about WAKIX® (pitolisant) after someone mentioned it in an online support group, and she also saw it on social media. What interested Tara most about WAKIX was that it wasn’t a controlled substance.

“WAKIX is FDA approved to treat excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and to treat EDS in children 6 years of age and older with narcolepsy,” explained Wermter. “It is also the first and only FDA-approved treatment for people with narcolepsy that is not a controlled substance,” she added. A controlled substance is defined as a drug or chemical that is regulated by the government based on its potential for abuse and dependence. “In a clinical study in adults, WAKIX did not show potential for abuse, similar to placebo, which is also known as a sugar pill,” Wermter further explained.

Tara asked her healthcare provider about WAKIX, and they had discussions that led to her starting WAKIX in 2020.

Partnering with your healthcare provider

When Tara began discussions with her healthcare provider about starting WAKIX, he mentioned that there would be a titration period where they start out with a lower dose and then work up to find the dose that was right for her. They also discussed expectations from treatment and possible side effects with WAKIX.

When starting a new medication, it’s important to talk with your healthcare provider so they can help you understand what to expect. “When I start a new patient on WAKIX, I tell them it‘s important to be in communication and be honest about how they’re feeling. I explain that we’ll start at a lower dose and then will increase the dose for the next two to three weeks until we find the dose that is right for them,” Wermter explained. “I want my patients to understand that everyone responds to medications differently, and for some patients it may take up to 8 weeks to achieve a clinical response. As such, it’s important they give WAKIX a chance to work.”

Tara started to notice that WAKIX was working when her friends and family noticed that she had more wakefulness. “They were excited for me,” she shared. “To have that kind of support around me felt reassuring that I wasn’t all alone.”

Finding support is important

Tara at kitchen table with friends using laptop computers.

An important aspect of navigating life with narcolepsy is the support from others. Tara found this through online support groups with others living with narcolepsy and felt that this is something that helped her in navigating through day-to-day life with narcolepsy. Since her diagnosis, Tara has been an active advocate in the narcolepsy community. “It’s important to me to be an advocate in the narcolepsy community and share my personal story because I want to help others know that they’re not alone and helpful resources are available,” Tara explained.

If you or someone you know is living with narcolepsy, speak with a healthcare provider to see if WAKIX could be an option. Read more about WAKIX below. To see videos about the experiences of Tara and others living with narcolepsy who are taking WAKIX, visit WAKIX Personal Stories.

Indications and Usage

WAKIX is a prescription medicine used to treat:
• excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
• excessive daytime sleepiness (EDS) in children 6 years of age and older with narcolepsy.

Important Safety Information

Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease.

WAKIX can cause a change in the electrical activity of the heart known as QT prolongation. This is a heart rhythm problem that can lead to an abnormal heartbeat. You have a higher chance of getting QT prolongation if you have certain heart or other medical conditions, or if you take WAKIX with certain medicines. Tell your healthcare provider right away if you have a change in your heartbeat or if you feel dizzy or faint while taking WAKIX.

Tell your healthcare provider about all your medical conditions, including if you have any heart, liver, or kidney problems, or problems with blood levels of your electrolytes, such as potassium or magnesium.

Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking WAKIX with certain medicines may cause side effects or affect the way each other works.

Hormonal birth control methods may not work while taking WAKIX. Use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after stopping WAKIX.

Tell your healthcare provider if you are pregnant or planning to become pregnant. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. The registry collects information about the health of you and your baby. To enroll or obtain information from the registry, call 1-800-833-7460.

The most common side effects of WAKIX in adults include insomnia, nausea, and anxiety. The most common side effects of WAKIX in children include headache and insomnia. These are not all the possible side effects of WAKIX. Call your healthcare provider for medical advice about side effects.

It is not known if WAKIX is safe and effective to treat excessive daytime sleepiness in children under 6 years of age with narcolepsy or to treat cataplexy in people under 18 years of age with narcolepsy.

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. You can also report negative side effects to Harmony Biosciences at 1-800-833-7460.

Please see accompanying Full Prescribing Information.

WAKIX is a registered trademark of Bioprojet Europe, Ltd.
Harmony Biosciences name and logo are registered trademarks.
© 2024 Harmony Biosciences. All rights reserved.
US-WAK-2400684/Oct 2024

Debunking myths and misinformation during flu season

2024-10-31T08:59:00

(BPT) – Respiratory illness season has officially begun. As the holidays approach and many spend more time indoors with loved ones, the risk of contracting common respiratory illnesses like flu, COVID-19, pneumonia and RSV will rise.

But germs aren’t the only things spreading this fall and winter; many vaccine-related myths and misinformation are also circulating and posing a risk to the health and safety of communities. Here are four common myths to look out for this season:

  • Myth #1: I’m healthy, so I don’t need to get vaccinated. This is false. Vaccines are a safe and dependable way to help build immunity even in healthy individuals. Vaccines are the number one way to protect against respiratory illnesses and reduce the severity of symptoms if you do get sick. This time of year can be busy, but it’s critical that everyone takes the time to get their annual flu shot, updated COVID-19 vaccine, and other CDC-recommended immunizations, like RSV and pneumonia (pneumococcal). Getting vaccinated also reduces the chances that you’ll spread respiratory illnesses to people who are at higher risk of developing severe complications.
  • Myth #2: It’s too late to get vaccinated. If you haven’t gotten the flu, COVID-19 or RSV vaccine, it’s not too late. However, you should get your recommended vaccines as soon as possible, especially before you travel or gather this holiday season to allow time for immunity to fully develop and increase your protection. Walgreens makes it simple to get all the recommended vaccines you need in one visit. To schedule a vaccination appointment in English or Spanish, use the Walgreens app, visit Walgreens.com/ScheduleVaccine or call 1-800-WALGREENS. We offer flexible openings, including nights and weekends, and walk-ins are welcome.
  • Myth #3: I won’t be able to afford my vaccinations. The flu shot and other recommended vaccines are covered by most insurance plans, and for those who are uninsured, Walgreens offers 200,000 flu shot vouchers annually to provide free flu immunizations for medically underserved populations that need them most. Vouchers are available in-store and at clinics operated by Walgreens off-site, while supplies last. Talk to your local pharmacist about voucher availability in your area. This voucher program is part of a broader effort by Walgreens to help ensure underserved and at-risk communities stay safe from respiratory illnesses while improving awareness, access and equity to vaccines.
  • Myth #4: I have mild symptoms, so I don’t need to get tested for flu or COVID-19. Flu and COVID-19 have similar symptoms to the common cold or other respiratory illnesses. Individuals who are experiencing a runny nose, cough or other respiratory symptoms should consider getting tested to know with greater confidence which virus they may have and before traveling or gathering with loved ones. This ensures individuals can quickly take the necessary steps toward recovery and avoid spreading illnesses to people at higher risk for complications. Walgreens offers a variety of convenient, low-cost options for flu and COVID-19 testing, including an easy combination test for COVID-19 and influenza A/B with results in 30 minutes or less, for $24.99. At-home tests, along with over-the-counter medicine cabinet essentials, are available for delivery in as little as 1 hour. And, if you are sick or just looking for affordable, convenient home delivery, Walgreens offers Same Day Prescription Delivery for $5.99 at more than 8,000 Walgreens with no membership required.

Walgreens: Your partner in health

Walgreens is your one-stop resource for all your immunization, testing and treatment needs this holiday season. If you have any questions, our expert pharmacists are here to help navigate the latest vaccination guidance and what is recommended for you and your loved ones.

Schedule your vaccine now at Walgreens.com/ScheduleVaccine.

Seizure Reduction Starts with Epilepsy Awareness

2024-10-28T07:01:00

(BPT) – This article is sponsored by SK Life Science, Inc.

Epilepsy is a neurological disorder that affects over 3 million Americans, and remains misunderstood by many. Characterized by unpredictable seizures, it can have a profound impact on a person’s day-to-day activities, relationships, and mental health. Yet, with increased awareness, education, and access to proper treatment, those living with epilepsy can work toward a life with fewer seizures.

This November, as the nation observes National Epilepsy Awareness Month, it’s an important opportunity to shed light on this often-misunderstood condition and advocate for better care and support for the epilepsy community.

Why Epilepsy Awareness Matters

Despite its prevalence, many misconceptions about epilepsy persist. Seizures, which vary widely in type and severity, are not always easy to identify, and the causes of epilepsy can be complex, ranging from genetics to brain injury. Public awareness campaigns during National Epilepsy Awareness Month aim to dispel myths, highlight the realities of living with epilepsy, and encourage people to learn more about seizure first aid.

Educating the public is crucial, not only to improve the lives of those with epilepsy but also to foster an understanding community. When those around them—family, friends, coworkers—know how to respond to a seizure, it can lead to faster intervention and a stronger support system for the person experiencing the seizure.

Striving for Better Outcomes

While living with epilepsy presents challenges, many people are unaware of the progress in seizure management and treatment options. Seizure control has come a long way in recent years, with advances in medications and individualized treatment plans offering hope to many who may have felt they had few options.

One key step for patients is working closely with a doctor, often an epileptologist or neurologist, to find the right treatment plan for their specific condition. Epileptologists are experts in managing epilepsy and can help patients explore the latest therapies designed to target uncontrolled seizures, empowering them to regain control of their lives.

The Path to Seizure Reduction

National Epilepsy Awareness Month highlights the important goal shared by many patients and doctors: reducing the frequency and impact of seizures. While eliminating seizures entirely may not always be possible, today’s treatments offer promising outcomes. It’s essential for individuals with epilepsy to consult regularly with their healthcare providers to evaluate and adjust their treatment plans to achieve the best possible seizure reduction.

One such treatment option is XCOPRI® (cenobamate tablets) CV, a prescription medication approved for the treatment of partial-onset seizures in adults 18 and older, which has been shown to reduce the frequency of seizures in some patients. If you or a loved one struggles with uncontrolled seizures, consider discussing treatment options like XCOPRI with your doctor.

Like any medication, XCOPRI has risks and benefits. Do not take XCOPRI if you are allergic to it or have a genetic problem (called familial short QT syndrome) that affects the electrical system of the heart. XCOPRI can have serious side effects including serious allergic reaction which may affect organs and other parts of your body like the liver or blood cells. XCOPRI may cause problems with the electrical system of the heart (QT shortening). Antiseizure drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your doctor right away if you have suicidal thoughts or actions, or new or worsening depression, anxiety, or irritability. XCOPRI may cause problems that affect your nervous system, including dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

These are not all of XCOPRI’s side effects. We encourage you to read the Important Safety Information included at the end of this article. Before considering XCOPRI®, it is vital to consult with your healthcare provider to determine if it is suitable for your specific needs. For more information, please visit www.xcopri.com.

How You Can Help

Whether you live with epilepsy or want to support someone who does, there are many ways to get involved during National Epilepsy Awareness Month. Take time to learn about seizure first aid, advocate for increased research funding, or raise awareness in your community or online. Every action brings us closer to a world where individuals living with epilepsy can experience better seizure management and thrive with greater confidence and support.

IMPORTANT SAFETY INFORMATION and INDICATION for XCOPRI® (cenobamate tablets) CV

DO NOT TAKE XCOPRI IF YOU:

  • Are allergic to cenobamate or any of the other ingredients in XCOPRI.
  • Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart.

XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider.

QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting.

Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood.

Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you.

Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider.

DISCONTINUATION:

Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

DRUG INTERACTIONS:

XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

PREGNANCY AND LACTATION:

XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use.

Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org.

Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI.

COMMON SIDE EFFECTS:

The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired.

These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

DRUG ABUSE:

XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law.

INDICATION:

XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older.

It is not known if XCOPRI is safe and effective in children under 18 years of age.

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

Please see full Prescribing Information and Medication Guide.

PM-US-XCOP-1495 10/24

Seniors: Prevent falls with these 3 easy moves

2024-10-23T16:25:00

(BPT) – If you’re an American over age 65, or have a senior loved one, you know how big of a risk falls can be in daily life. As people age, their balance becomes less steady, which can lead to an increase in stumbles and tumbles. But it can mean more than the inconvenience of a turned ankle. The Centers for Disease Control and Prevention (CDC) reports falls are the leading cause of injury and death from injury among people 65 and older. About three million seniors visit the emergency room due to falls every year.

The good news? There are simple steps you can take to reduce your risk of falling. It’s about increasing balance and stability.

“While the risk of falls increases as we age, it’s not inevitable,” said Dina Sexton, a national trainer for SilverSneakers, the nation’s leading fitness and well-being improvement program for seniors. “There are many simple, customizable exercises that can reduce the risk of falls. A steady sense of balance is the key.”

For those 65+, the right health plan can provide benefits to improve balance and prevent falls. According to a recent study by Tivity Health, a leading provider of health and wellness solutions, including SilverSneakers, 22% of Medicare Advantage beneficiaries report having fallen in the past year compared to 26% in traditional Medicare. Those who participate in SilverSneakers report the fewest falls at 14%. SilverSneakers members are also less likely to feel unsteady when standing or walking and are less worried about falling.

Almost all physical activity helps lower the risk of falls. Movement of any kind improves body awareness, helps build bone density and even increases muscle mass. Falls happen most often while you’re doing something mundane — going down a flight of stairs, changing a lightbulb, or walking on a slippery floor. That’s why it’s important to focus on “functional training,” which helps strengthen your body for everyday activities, said Sexton.

What’s functional training? It’s an exercise designed to mimic the types of movements you do in everyday life, like squatting, lifting, stepping up and down, balancing, walking, reaching above your head and more.

These types of moves require multiple muscle groups to work together, boosting coordination and allowing you to move in different planes of motion — from side to side and back and forth. Doing this helps improve joint health, and it gives you a better understanding of the way you move in general. Put another way, it gives people the strength and stability needed to avoid falls and ultimately to live independently.

Here are a few exercises you can do at home to help avoid falls. But before you do, consult a doctor for their advice and recommendations.

Sit-to-stand

Difficulty getting up and down from things like a dining room chair or a toilet seat can cause you to feel unsteady, which contributes to falls.

  • Sit on a sturdy chair of standard height. Have a support in front of you, like the kitchen table or a countertop, to use if you feel unsteady.
  • Lean forward and squeeze your gluteal muscles to stand up. The goal is to not use your hands.
  • Repeat 10 times.

Balance exercises

Balance is the key to stability. Practice your balance this way:

  • Stand by your kitchen counter or in a corner, so you’ll have something to reach out to if you lose your balance.
  • Move your feet apart, shoulder width. Hold that pose steady, without swaying, for 10 seconds with your eyes open. Work your way up to 30 seconds.
  • When you can hold that pose for 30 seconds without swaying, do the same with your feet together.
  • When you feel confident with your feet together, do the same on one foot, then the other.
  • When you’re confident with those poses, do them all with your eyes closed.

Heel raise

Heel raises can strengthen your calf and thigh muscles, improving balance and flexibility.

  • Stand in front of your kitchen counter or by a sturdy kitchen chair with your feet flat on the floor, shoulder-width apart.
  • Lift both heels off the floor, so you’re standing on the balls of your feet.
  • Lower your heels so your feet are flat.
  • Repeat 10-15 times.

The key to these exercises, said Sexton, is to do them consistently. A few minutes a day will make a big difference in your balance, flexibility and strength.

Tivity Health, through its flagship brand SilverSneakers, is the nation’s leading community fitness and well-being improvement program that helps eligible Medicare Advantage members stay physically active, socially engaged and mentally sharp. The program includes a fitness center membership and virtual classes that foster social interaction among members and encourage them to live healthy, active lifestyles. The program is available to more than 19 million Americans through many Medicare Advantage plans, Medicare Supplement carriers and group retiree plans.

With the right Medicare Advantage plan, joining a senior fitness program is easy. And, with over 30 years of experience serving the senior population and offering classes for every fitness level, it’s an excellent way to get fit, stay engaged, reduce falls and be healthy. If you aren’t currently on an MA plan, the annual Medicare Enrollment Period between Oct. 15 and Dec. 7 is a perfect time to review plans and find one that includes SilverSneakers. Visit silversneakers.com to learn more.

One Patient’s Journey with Relapsed Diffuse Large B-Cell Lymphoma and What He Wants You to Know

2024-10-22T11:01:00

(BPT) – The word “cancer” can immediately turn someone’s world upside down. The six-letter word has the power to bring a flood of emotions with it – fear, anxiety and confusion. But learning about common symptoms to watch for and the impact of different types of cancer can help bring understanding and preparedness. That’s why Michael, an Ohio native living with an aggressive blood cancer known as diffuse large B-cell lymphoma (DLBCL), wants to share his story.

What to Know About This Type of Lymphoma

DLBCL is a type of aggressive, fast-growing non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell.[1],[2] DLBCL is the most common subtype of NHL, with more than 18,000 people being diagnosed with this type of cancer each year in the U.S.[3] While DLBCL can occur at various ages, it is most frequently diagnosed among people aged 65-74.[4] The symptoms associated with DLBCL often resemble those of more common conditions, such as: enlarged lymph nodes, painless swelling in the neck, underarms or groin; unexplained weight loss; fatigue and/or lack of energy; and chills, fever and/or excessive sweating, often at night.[5],[6]

Despite being labeled as an “aggressive” cancer, DLBCL is curable for some.[7] However, about 30-40% of people with DLBCL develop relapsed or refractory (R/R) disease,[8] which means their cancer returns after initial treatments and/or their cancer stops responding to treatment.

People with R/R DLBCL experience significant treatment challenges, with outcomes worsening with each line of treatment.[9] The heartbreaking reality is that 1 in 3 patients will not survive 5 years after receiving a DLBCL diagnosis.[10]

How Michael Still Lives Life on His Own Terms

Michael, a 66-year-old, received the devastating diagnosis of DLBCL in 2016. He had coached softball and football for 32 years and loved being involved in his community, which had to be put on pause. Living with DLBCL can be difficult, especially for those who enjoy outdoor activities, as the disease can cause fatigue and/or lack of energy.

Adjusting to life with DLBCL can be hard, but thinking about how this would affect his children was even harder. “Not knowing if you have a tomorrow is a very unpleasant thing, and not knowing if you’ll be there for your family is even worse,” Michael shared. But he was able to push forward and finish treatment, driven by the desire to be there for his family and community. For five years, Michael was in remission.

In 2021, Michael’s cancer returned. He had gone through various treatments for his initial diagnosis already, including chemotherapy and radiation. But this time was different, and Michael would try several additional treatment options such as chemoimmunotherapy, CAR T therapy and a clinical trial.

Michael was also remarried now and had Kimberly in his life. Michael and Kimberly connected in 2018 after Kimberly came to watch her granddaughter’s soccer game that Michael was coaching. They fell in love and got married 6 months later. Kimberly became Michael’s Care Partner – a term used to refer to a “caregiver” who provides someone with physical and emotional support – and has been by his side for all aspects of his cancer treatment.

“Kimberly is a true blessing,” Michael said. “She is an absolute rock.” Kimberly acknowledged that Michael’s life with DLBCL had been challenging, but that they had many reasons to maintain hope. Her advice to others is to “think of treatments like water stations in a marathon: something may not be working, or may not work long term, but there can be something else ahead. Your health is not a sprint. It’s a marathon.” As it turned out, Michael was arriving at his next water station. He and his physician decided to try a bispecific antibody treatment known as EPKINLY® (epcoritamab-bysp) following his relapse.

Michael began treatment with EPKINLY in May 2023, and has been on it since. EPKINLY is the first and only subcutaneous bispecific antibody approved by the U.S. Food and Drug Administration to treat adults with certain types of DLBCL and high-grade B-cell lymphoma that has come back or that did not respond to previous treatment after receiving two or more treatments.[11] Treatment options are expanding, and EPKINLY offers a subcutaneous (just under the skin) injection option for patients living with this type of cancer.

Michael, along with his clinicians, noticed that he was responding to treatment well and said he is now in “a good place.” He enjoys every day he is able to spend time with Kimberly, his six daughters, and 10 grandchildren. Although Michael is still living with DLBCL, he shared that EPKINLY is helping to keep it under control – his bloodwork is normal, and his disease is stable. Michael’s physician also advised him to look out for certain signs and symptoms of infection during his treatment.

Michael’s journey with relapsed DLBCL has been ongoing for almost a decade, but with his support system and continued treatment with EPKINLY, Michael’s marathon continues.

What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Important Warnings—EPKINLY can cause serious side effects, including:

  • Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. Your first full dose of EPKINLY will be given on day 15 of your first cycle of treatment and you should be hospitalized for 24 hours after due to the risk of CRS and neurologic problems. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
  • Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.

EPKINLY can cause other serious side effects, including:

  • Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
  • Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.

These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).

Please see Medication Guide, including Important Warnings.

Please click to see Important Facts about EPKINLY, including Important Warnings for cytokine release syndrome and neurologic problems.

If you or someone you know has R/R DLBCL, speak with your doctor about potential therapies, including EPKINLY.

For more information, please visit epkinly.com.

COM-US-EPK-0001012


[1] Lymphoma Coalition. https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 2024.

[2] Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.

[3] Lymphoma Research Foundation. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/. Accessed April 2024.

[4] National Cancer Institute SEER. https://seer.cancer.gov/statfacts/html/dlbcl.html. Accessed April 2024.

[5] About Lymphoma and Lymphoma Subtypes. Lymphoma Research Foundation. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/. Accessed February 2024.

[6] Signs & Symptoms. Lymphoma Coalition. https://lymphomacoalition.org/signs-symptoms/. Accessed February 2024.

[7] Lymphoma Research Foundation. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/. Accessed April 2024.

[8] Cassandra Duarte et al., Management Considerations for Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma. Am Soc Clin Oncol Educ Book 43, e390802(2023).

[9] Ekberg, S., Crowther, M., Harrysson, S. et al. Patient trajectories after diagnosis of diffuse large B-cell lymphoma—a multistate modelling approach to estimate the chance of lasting remission. Br J Cancer 127, 1642–1649 (2022). https://doi.org/10.1038/s41416-022-01931-2

[10] National Cancer Institute SEER. https://seer.cancer.gov/statfacts/html/dlbcl.html. Accessed May 2024.

[11] EPKINLY [package insert].