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].

Innovative Treatment Potentially Spares Kidneys in Adult Patients with Low-Grade Upper Tract Urothelial Cancer

2024-10-16T11:01:01

(BPT) – Kathy was only in her sixties when she was diagnosed with low-grade upper tract urothelial cancer (LG-UTUC). It came as a complete surprise given she was young, exercised every day, ate right, and did everything else she could to keep herself healthy.

Cancer came calling anyway, and a rare form at that. Most patients who are diagnosed with urothelial cancers develop tumors in the lower tract, with only 5% to 10% having tumors in the upper tract,1 like Kathy’s. And none of the existing treatment options for LG-UTUC were appealing to Kathy or her family.

Treatment meant either removing her kidney and ureter, the tube connecting the kidney to the bladder, or having a cystoscopy to remove the tumors, along with ongoing tests and scans after the procedure to monitor for a recurrence. After discussing it with her husband, Kathy chose to keep her kidney and endure those procedures. But it wasn’t a durable solution.

“We agreed to keep going back in to check for recurrences,” said Stephen Bennett, MD, the Urology Group in Cincinnati, Ohio, Kathy’s doctor. “The next six or seven times we went back in after a procedure, there was a recurrence. Every single time.”

The cycle of removing the tumors, recurrence, followed by another painful procedure to remove those tumors, went on for years. But Dr. Bennett knew JELMYTO® (mitomycin) for pyelocalyceal solution, a drug not yet approved by the FDA at that time, could potentially be another treatment option for low-grade upper tract urothelial cancer that could benefit Kathy. He encouraged Kathy to continue her current treatment plan and wait a little longer before removing the kidney, in hopes the drug’s approval would come soon. And it did!

JELMYTO: A breakthrough in LG-UTUC treatment

That day came. In 2020 JELMYTO became the first FDA-approved therapy treatment for LG-UTUC in adult patients.2 JELMYTO is instilled in a procedure that spares the kidney.

“After JELMYTO was approved, we signed her up,” Dr. Bennett said.

“I didn’t even have to think about it,” Kathy said. “I was going to do it.”

JELMYTO combines mitomycin (chemo) with sterile hydrogel, a proprietary reverse-thermal technology (RTGel®) that allows the medicine to transform from a chilled liquid at instillation into a gel at body temperature. It is injected directly into the kidney via a catheter or a small port, and delivers treatment exactly where it is needed, not where it isn’t. This completes the primary treatment regimen for patients with low-grade UTUC, even those with endoscopically unreachable tumors, because it delivers chemoblative therapy directly to the upper tract.

JELMYTO stays in a kidney for four to six hours, fighting the tumors. Then, it slowly starts to liquify and naturally leaves your body when you urinate.

A clinical study called OLYMPUS followed adults who were in different stages of their journey with low-grade UTUC. Some were newly diagnosed, and over half had been treated for low-grade UTUC in the past. Some had very hard-to-reach tumors that could not be removed with endoscopic management. The findings showed that three months following initiation of treatment, 58% of participants had their tumors disappear after a once-a-week for six weeks treatment plan with JELMYTO.3 The most common side effects observed in OLYMPUS included urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

She received JELYMTO once a week for six weeks in an outpatient procedure. The results surprised even her doctor.

“After Kathy’s six rounds of treatment we waited six to eight weeks and we did the same cystoscopy and ureteroscopy that we had done many times before,” said Dr. Bennett. Fortunately, in Kathy’s case, Dr. Bennett saw no evidence of recurrence.

Six months later, Kathy went back to Dr. Bennett for a follow-up. No recurrence. Six months after that, still clear.

“It has changed my life as far as doing more things with the family,” Kathy said. “I’m looking forward to seeing my grandchildren grow up, enjoying life. It is a weight off of everybody’s mind. So that was the best part.” This treatment option had a positive impact on her life. To see more of Kathy’s story, visit: https://www.jelmyto.com/hcp/resources/video-library/.

Others with similar stories of frequent recurrence who do not wish to remove their kidney should consult their doctor about all their treatment options, including JELMYTO. For more information about JELMYTO, including access to a dedicated team of support throughout the coordination process, visit https://www.jelmyto.com/patient/ and talk to your doctor.

APPROVED USE FOR JELMYTO

JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

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

  • are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
  • Tell your healthcare provider if you take water pills (diuretic).

How will I receive JELMYTO?

  • Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
  • You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
  • JELMYTO is given to your kidney through a tube called a catheter.
  • During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.

After receiving JELMYTO:

  • JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
  • To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
  • Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.

JELMYTO may cause serious side effects, including:

  • Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
  • Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
  • The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

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 may also report side effects to UroGen Pharma at 1-855-987-6436.

Please visit www.jelmyto.com and see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.


1 Evmorfopoulos K, Mitrakas L, Karathanasis A, Zachos I, Tzortzis V, Vlachostergios PJ. Upper Tract Urothelial Carcinoma: A Rare Malignancy with Distinct Immuno-Genomic Features in the Era of Precision-Based Therapies. Biomedicines. 2023 Jun 21;11(7):1775.

2 Commissioner, Office of the. “FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer.” U.S. Food and Drug Administration, 14 Apr. 2020, www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treatment-low-grade-upper-tract-urothelial-cancer.

3 JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2022.

US-JEL-00927 09/24

5 tips for healthy hearing. Hint: Pickleball can help

2024-10-16T05:01:00

(BPT) – Pickleball is the fastest-growing sport in the country, with many seniors roaring onto pickleball courts nationwide. But whether it’s a friendly game or an intramural matchup, all senses must be engaged for the best play — especially our hearing.

Think about the last time you had your hearing tested. Was it recently? If it wasn’t and you find yourself turning up the television or straining to hear conversations in crowded rooms, it’s time to have an audiologist or hearing instrument specialist check your hearing.

According to the National Council on Aging (NCOA), hearing loss affects more than 60 million Americans ages 12 and older. By the time people reach age 65, more than 30% experience hearing loss, and that percentage only goes up as people age. The NCOA also reports nearly 30 million Americans could significantly benefit from wearing a hearing aid.

HearingLife + USA Pickleball

That’s why HearingLife, a global leader in hearing care, has become USA Pickleball’s official hearing care partner to raise awareness about the importance of hearing health and the dangers of hearing loss. HearingLife knows that participating in an active lifestyle — like a pickleball match — encourages an all-around healthy routine, including hearing care.

At select USA Pickleball events throughout the year, HearingLife is offering complimentary hearing assessments to attendees and players.

“Hearing loss can prevent people from doing activities they love, like pickleball,” said Dr. Leslie Soiles, HearingLife’s chief audiologist. “And it’s ironic because these types of activities and exercises can actually help slow hearing loss. That’s why getting your hearing checked is so important. It’s a gateway to a more active, fulfilling life.”

In addition to offering on-site services such as free screenings, HearingLife’s presence will include educational resources on how hearing loss can impact not only athletic performance, but also overall quality of life. Visitors can also learn about the latest advancements in hearing aid technology, including devices that are designed to enhance clarity in noisy environments — perfect for sporting activities like pickleball.

The risk of untreated hearing loss

Many people brush off hearing loss and don’t think about hearing as essential to health and longevity. Untreated hearing loss can lead to social isolation, loneliness, social withdrawal and even problems at work if you miss instructions or don’t understand coworkers. Worse, it can cause cognitive decline, memory problems and even increased risk of falls.

Caring for your hearing

You care for your teeth by brushing twice each day and for your body by eating right and exercising. What about your ears? Here are some ways to care for your hearing, from the pros at HearingLife.

1. Mind your exposure to loud noises. Loved those packed concerts in your youth? We did, too. For the reunion tour, it’s wise to wear earplugs. That also goes for exposure to construction sites or loud machinery.

2. Monitor how long you wear headphones or earbuds. Turn down the volume of your favorite podcast or playlist, and don’t wear the ear devices for an extended period of time.

3. Get regular checkups. Visit your hearing care professional on a regular basis, especially if you notice worsening hearing loss or other symptoms such as ringing in your ears.

4. Manage chronic conditions. High blood pressure, diabetes and smoking can contribute to hearing loss. Managing those conditions and quitting smoking helps keep your ears healthy.

5. Keep active. The improved blood flow you get from exercise is great for your ears. Walking, cycling, canoeing, working out at the gym, all contribute to good hearing health. Why not take up pickleball?

HearingLife is making it easy to get started. The company is sponsoring a giveaway to the USA Pickleball National Championships! One lucky winner and a plus-one can enter for a chance to win a three-night trip to Mesa, AZ, for the USA Pickleball tournament taking place Nov. 9-17. It’s free and easy to enter: just visit https://www.hearinglife.com/pickleball-sweepstakes and submit your email. The winner will be notified on Oct. 23.

Preparing for eating, traveling and socializing during the holidays

2024-10-14T08:01:00

(BPT) – The holiday season is a joyful but sometimes challenging time, especially for people living with diabetes who may be watching their sugar intake. Between treat-filled parties and meals and travel that could get in the way of healthy eating, it can be tough to manage glucose levels during this time of year.

To help you make the most of the holiday festivities, here are tips to help you feel your best and enjoy your time without compromising your health.

Smart food strategies

When hosting, you have control over the menu, so you can select foods that help you feel your best. For example, the Centers for Disease Control and Prevention advises people living with diabetes to choose whole foods over highly processed foods, plus non-starchy veggies like spinach, broccoli and green beans. They also recommend limiting added sugars and refined grains (pasta, white bread and rice). Combining certain foods can help maintain glucose levels as well.

“Combining carbs in meals with protein, fat or fiber can help keep your glucose steady,” said Sara Thomas, a registered dietitian and research scientist with a Ph.D. in nutrition science and expertise in diabetes and obesity. “For example, you can serve whole grains, like brown rice, alongside lean protein, a salad and/or roasted veggies to help balance your glucose.”

When you’re not the host, it can be stressful being unsure what food and drinks will be served. If you’re attending a party, offer to bring a dish that works well with your glucose management, like:

Find more meal ideas to help keep you on track on the American Diabetes Association website.

Snacks, the key to instant happiness — and balanced glucose!

Just like not showing up empty-handed to a holiday party or family gathering, you shouldn’t show up hungry, either. Having a snack prior to the get-together can help with minimizing glucose highs or lows.

“You might think waiting until a party to eat means you’re saving up calories, but if you show up hungry you might overeat and make not-as-healthy choices,” added Thomas. “Have a healthy snack first that pairs carbs with fats or proteins, like an apple with peanut butter.”

Additionally, if you choose to drink alcohol, remember alcohol affects people in different ways. It’s best not to drink on an empty stomach, and it’s recommended to stick to one serving of alcohol for women and two servings for men. It’s also a good idea to drink water before and after drinking alcohol.

When you’re living with diabetes, utilizing a continuous glucose monitor like Abbott’s FreeStyle Libre 3 Plus sensor can show you your glucose numbers in real-time and help you easily see glucose patterns, empowering you to make more informed decisions*,1 around what to eat and drink during the holidays, without the need for fingersticks^.

Navigating social interactions

If you’re living with diabetes or shared with your family and friends that you’re monitoring your glucose, they may comment on what you’re eating or drinking when you’re at a gathering. While most likely well-intentioned, these comments can add additional stress beyond just watching what you’re eating, which can also negatively impact your glucose levels.

One way to manage this is to respond with something like, “I appreciate your questions and concerns. This is what works best for me.” If you feel comfortable, you could show them insights from your continuous glucose monitor and explain how it has helped with improving your glucose control.

Explore more, worry less: Savvy traveling tips

In addition to thinking through what you’re eating and drinking during the holidays, travel can add even more stress that can impact your glucose levels. Like preparing for holiday gatherings, you can prepare for travel, too. For example, you can pre-package balanced snacks to pack alongside your medicines and diabetes supplies if you’re living with diabetes. Here are additional ideas to reduce holiday travel stress:

  • Pack snacks like nuts, dried fruits, cheese and high-protein/high-fiber bars.
  • Allow extra time to get through security to reduce stress.
  • Choose flights with at least one-hour layovers (for connected flights) to prevent rush and worry.
  • Pack diabetes medications and extra supplies in carry-on bags, not checked luggage (which could be lost or delayed).

You’ll enjoy the holidays a lot more if you plan ahead, so you can better cope with potential stressors that impact your mental and physical health. A little preparation makes festive meals, socializing and travel less likely to disrupt your glucose levels.

For more tips to help you live with diabetes and to see if you qualify for a free sensor, visit MyFreeStyle.com.

* Study was performed with the outside US version of the FreeStyle Libre 14 day system. Data is applicable to the FreeStyle Libre 2 system and FreeStyle Libre 3 system, as feature sets are similar as FreeStyle Libre 14 day system, excluding alarms.

^ Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first twelve hours.

1. Fokkert, Marion, et al. “Improved Well-Being and Decreased Disease Burden After 1-Year Use of Flash Glucose Monitoring (FLARE-NL4).” BMJ Open Diabetes Research & Care 7, no. 1 (2019): e000809. https://doi.org/10.1136/bmjdrc-2019-000809.

The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app.

Important Safety Information:
FreeStyle Libre 3 Plus is prescription only, for important safety information, please visit https://www.freestyle.abbott/us-en/safety-information.html.

The holiday season is a joyful but sometimes challenging time, especially for people living with diabetes who may be watching their sugar intake. Between treat-filled parties and meals and travel that could get in the way of healthy eating, it can be tough to manage glucose levels during this time of year.

Managing COVID-19 This Season: What You Need to Know and How to Stay Informed

2024-10-10T14:35:00

(BPT) – COVID-19 can affect anyone, so it’s important to stay informed as we approach another respiratory virus season. This infographic offers key insights on COVID-19 vaccinations, transmission, increased risk factors, Long COVID risks, and the benefits of getting your flu shot at the same time. It also explains when and how to get your updated vaccine for the year. Always talk to your doctor if you have any questions or concerns about vaccinations this season. To find your local vaccine availability and COVID-19 resources, please visit: https://www.ForYouAndThem.com/.

Infographic

Living with CIDP and Pathways to Innovative Treatment

2024-10-10T14:01:00

(BPT) – “At first I was kind of like, what is that? What is CIDP? I’ve never heard of that. But then, the relief set in more than confusion … because at least there was a name to what I had.”

Jamilah’s days were once filled with vibrant activities like dance classes, crocheting, and running a photography business. Her life was active — a true reflection of her passion and creativity. But in September 2021, everything changed. Jamilah began to have trouble standing up and moving around. She experienced numbness and tingling sensations in her hands, and within weeks, these symptoms rapidly progressed, spreading to other parts of her body. Soon, she found herself confined to a wheelchair. Only later was she diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). Today, her life has changed dramatically from those days filled with vibrant activities, with most of her time spent at home. Her CIDP care requires monthly visits to an infusion center, and she is forced to rely on a wheelchair to get around. Hoping to deepen awareness and understanding of CIDP, Jamilah is an advocate, sharing her story to highlight that recovery is not linear, but reclaiming joy in one’s life.

Understanding CIDP

Chronic inflammatory demyelinating polyneuropathy, or CIDP, is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. This condition can lead to significant reductions in arm and leg function, frequent falls, and in severe cases, dependence on a wheelchair, rendering many individuals unable to work.

“CIDP can be debilitating and have a significant impact on quality of life. Many patients with CIDP require treatments that may be burdensome,” says Lisa Butler, Executive Director of the GBS|CIDP Foundation. The effects of CIDP extend beyond physical limitations, impacting daily life at home, work, and school. A cross-sectional study assessing limitations in activities among 147 patients with CIDP found that 85% reported difficulty running, 80% reported difficulty standing for longer periods of time, and 75% reported difficulty dancing. Additionally, more than 75% of patients reported sensory deficits.

In the United States alone, approximately 24,000 people are currently being treated for CIDP, yet there remains a considerable unmet need for effective and manageable therapies. “Existing therapies have traditionally been limited to corticosteroids and plasma-derived treatments, which, while effective for many, present challenges for some patients,” says Jeffrey Allen, M.D., Professor, Department of Neurology, University of Minnesota. Studies have shown an estimated 85% of patients require ongoing treatment with potentially time-consuming therapies and 88% of treated patients report residual neurological symptoms.

A New Era in CIDP Treatment

As new, targeted treatment options become available, patients stand to benefit from having an expanded arsenal of medications.

For Jamilah, her hope is to find a solution that could turn her dreams into reality — reviving her crochet business and launching a dance studio that welcomes both wheelchair users and differently abled dancers, giving them a place and community to express their creativity and passion for dance.

The potential of offering new innovative treatment options for patients like Jamilah and others living with autoimmune diseases is what motivates companies like argenx to continue innovating. “Every day, we are turning science into real solutions for patients suffering from severe autoimmunity,” says Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

To learn more about CIDP and advancements being made in autoimmune diseases, visit https://www.argenx.com/. If you are interested in learning more about CIDP treatments, please speak with a healthcare provider.

The Impact of Primary Biliary Cholangitis (PBC): A Rare Autoimmune Disease

2024-10-09T07:01:00

(BPT) – Imagine waking up every day feeling utterly exhausted, no matter how much sleep you get. Now, add an unbearable itch that just won’t go away, dry eyes and mouth, and stomach pain. This is the reality for some people living with primary biliary cholangitis (PBC).

A Closer Look at Primary Biliary Cholangitis

Primary biliary cholangitis is a rare autoimmune disease in which the immune system mistakenly attacks and slowly destroys the bile ducts in the liver. Over time, this can lead to inflammation of the bile duct and scarring of the liver and may cause serious complications.1

The symptoms of PBC can at first be mild and get worse over time, and it may take 5 to 20 years to develop.1 Common signs are chronic itch (pruritus) and extreme fatigue, both of which may impact daily life.1,2 Some patients may have no symptoms, therefore the disease is oftentimes only discovered through routine liver blood tests.3

The Challenges of Getting a PBC Diagnosis

“The symptoms aren’t always obvious,” shares Naveen, a patient with PBC. “There haven’t been many treatments available for me in the past, which can be disheartening, especially with the intense symptoms that really affect my life on a daily basis.”

For many, the journey to diagnosis may involve numerous tests and procedures.4 The experience can be emotionally and physically exhausting, especially given the impact that untreated PBC can have on a person’s health.2

A Disease That Disproportionately Affects Women

PBC is more common in women, particularly those who are over 40 years old, with approximately 1 in 1000 women in this age group affected and 65 out of every 100,000 women in the US diagnosed with the condition.3,5 Although the disease is more prevalent in women, an increasing number of men are now being diagnosed. On average, women receive a diagnosis within 12 months, while for men, the process can take up to three years.6

If left untreated, PBC can lead to permanent liver damage, and even severe cases of liver failure.1 Early diagnosis and proactive management of the disease can play an important role in reducing the risk of complications and may help in improving the health of those affected.7,8

Living With PBC: The Daily Reality

Living with PBC means more than just managing the physical symptoms; it’s also about coping with the emotional and psychological toll that the disease can take. This could be incessant itching, debilitating fatigue, or other symptoms that can make it difficult to maintain a normal lifestyle, impacting work, social relationships, and overall well-being.2

For those with PBC, connecting with patient advocacy groups and support communities may offer both practical advice and emotional comfort, helping to navigate the complexities of living with this chronic condition.9,10

Moving Forward

While the challenges of living with PBC can be significant, advancements in understanding the disease and ongoing research into new treatment options offer hope.11 For people living with PBC, some treatment goals include improving or normalizing alkaline phosphatase (ALP) levels and managing symptoms of the disease, such as pruritus.2,12,13 A treatment plan that helps sustain ALP levels and more effectively fights debilitating symptoms may help improve disease outcomes.2,12,13

If you or someone you know is experiencing symptoms that might suggest PBC, it’s important to seek medical advice. Early detection and proactive management may help make a difference in the course of the disease and the outcomes of those affected.7,8

References

  1. Mayo Clinic. Primary biliary cholangitis. Accessed August 29, 2024. Available at: https://www.mayoclinic.org/diseases-conditions/primary-biliary-cholangitis/symptoms-causes/syc-20376874
  2. Sivakumar T, Kowdley KV. Anxiety and depression in patients with primary biliary cholangitis: current insights and impact on quality of life. Hepat Med. 2021;13:83-92. doi:10.2147/HMER.S256692
  3. American Liver Foundation. Primary biliary cholangitis. Accessed August 29, 2024. Available at: https://liverfoundation.org/liver-diseases/autoimmune-liver-diseases/primary-biliary-cholangitis-pbc/
  4. Mayo Clinic. Primary biliary cholangitis diagnosis. Accessed September 17, 2024. Available at: https://www.mayoclinic.org/diseases-conditions/primary-biliary-cholangitis/diagnosis-treatment/drc-20376880
  5. Hohenester S, Oude-Elferink RP, Beuers U. Primary biliary cirrhosis. Semin Immunopathol. 2009;31(3):283-307. doi:10.1007/s00281-009-0164-5
  6. Abdulkarim M, Zenouzi R, Sebode M, et al. Sex differences in clinical presentation and prognosis in patients with primary biliary cholangitis. Scand J Gastroenterol. 2019;54(11):1391-1396. doi:10.1080/00365521.2019.1683226
  7. Martini F, Balducci D, Mancinelli M, et al. Risk stratification in primary biliary cholangitis. J Clin Med. 2023;12(17):5713. doi:10.3390/jcm12175713
  8. Cleveland Clinic. Primary biliary cholangitis (PBC): living with this chronic disease. Accessed August 29, 2024. Available at: https://health.clevelandclinic.org/living-with-pbc
  9. National Organization for Rare Disorders. Primary biliary cholangitis organization. Accessed September 17, 2024. Available at: https://rarediseases.org/organizations/primary-biliary-cholangitis-organization/
  10. Global Liver Institute. Primary biliary cholangitis (PBC) externally-led patient-focused drug development (EL-PFDD). Accessed September 17, 2024. Available at: https://globalliver.org/wp-content/uploads/2023/02/PBC-EL-PFDD.pdf
  11. Bernal RB, Castro CM, Ferrigno B, et al. Management of primary biliary cholangitis: current treatment and future perspectives. Turk J Gastroenterol. 2023;34(2):89-100. doi:10.5152/tjg.2023.22239
  12. Murillo Perez CF, Harms MH, Lindor KD, et al. Goals of treatment for improved survival in primary biliary cholangitis: treatment target should be bilirubin within the normal range and normalization of alkaline phosphatase. Am J Gastroenterol. 2020;115(7):1066-1074. doi:10.14309/ajg.0000000000000557
  13. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394-419. doi:10.1002/hep.30145

GILEAD and the GILEAD Logo are trademarks of Gilead Sciences, Inc.

© 2024 Gilead Sciences, Inc. All rights reserved. US-UNBC-2497 09/24

Navigating Mental Illness and Tardive Dyskinesia: One Woman’s Story of Resilience

2024-10-08T15:57:00

(BPT) – This article was sponsored and developed by Neurocrine Biosciences, Inc. Allison was compensated by Neurocrine Biosciences to share her story.

The first week of October is recognized as Mental Illness Awareness Week, an essential time to support and advocate for the one in five adults in the United States living with a mental illness. As advocates work to raise awareness for these individuals and their care partners, it’s important to remember that those taking antipsychotic medication to treat mental illnesses, such as bipolar disorder, major depressive disorder, schizophrenia and schizoaffective disorder, may also have tardive dyskinesia (TD).* TD is a persistent, involuntary movement disorder associated with use of antipsychotic medication that affects approximately 600,000 or more people in the U.S.

Allison grew up in San Diego and has been participating in performance arts since she was a kid, including theater, acting and writing. While working at her first night shift radio job at the age of 28, she began losing sleep and started behaving erratically. Shortly after, she was diagnosed with bipolar disorder and prescribed both an antipsychotic and antidepressant. Allison’s doctor discontinued the antipsychotic after only three days, but she continued taking the antidepressant and a mood stabilizer. She later moved to Florida for a fresh start but saw her bipolar disorder symptoms increase after her antidepressant suddenly stopped working. She was again prescribed an antipsychotic medication and worked with her doctors over the next few years to find the best treatment to manage her symptoms and regain mental stability in her life.

However, eight years after beginning antipsychotic treatment, Allison began to experience uncontrollable movements, including a twisting torso, jerky legs, mouth movements and rapid blinking. “When I tried to sleep, my legs and arms flailed and I would kick my husband, like my whole spine was jumping. I became self-conscious and started sleeping on the couch,” she said. “My frame was rattling violently, like a car driving through potholes with bad shock absorbers. It was really scary.” After visiting several neurologists over the course of many years and wondering if she would ever receive answers, Allison was diagnosed with TD.

Mild, moderate or severe TD movements can occur in different parts of the body and can negatively impact people physically, socially and emotionally. People living with TD may also feel judged and ashamed, adding to a sense of worry, isolation and stigma. Even mild uncontrollable body movements from TD can have emotional and social consequences. “My symptoms were affecting my ability to sleep, work and live my life as I wanted to,” Allison said.

It’s important that people who are taking antipsychotic medication be monitored and screened by a healthcare provider for drug-induced movement disorders, such as TD, as part of their routine appointments. Proactive recognition and treatment of TD can make a positive impact in the lives of many people experiencing mental illness. While TD is unlikely to get better on its own, it is a treatable condition.

After researching potential treatment options and discussing the benefits and risks with her healthcare provider, Allison was prescribed INGREZZA® (valbenazine) capsules. INGREZZA is a one-capsule, once-daily medication that’s proven to reduce TD in adults and is the #1 most prescribed vesicular monoamine transporter 2 (VMAT2) inhibitor. VMAT2 inhibitors are recommended by the American Psychiatric Association as first-line treatment for patients experiencing TD. In a clinical study, INGREZZA was proven to reduce TD in adults at six weeks, and most people saw results in just two weeks.†‡ The most common side effects of INGREZZA in people with TD are sleepiness and tiredness.

IMPORTANT SAFETY INFORMATION

INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.

Do not take INGREZZA or INGREZZA SPRINKLE if you are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.

Please see full Important Safety Information, including Boxed Warning, below and full Prescribing Information and Medication Guide.

Smiling Allison wearing a light colored blouse with jacket and necklaces.

After a few weeks of taking INGREZZA, Allison experienced fewer uncontrollable movements. “Now that I have been on INGREZZA and experience fewer movements, I’m not as consumed with embarrassment and discomfort over my TD symptoms,” she said. “I’m glad I never gave up and advocated for myself because now my husband can fall asleep in the same bed as me again due to the decrease in my movements.” Individual results may vary.

This Mental Illness Awareness Week, Allison wants to share her mental health journey to encourage others to support those living with mental illnesses and people experiencing uncontrollable movements to persevere and discuss symptoms and treatment options, such as INGREZZA, with their healthcare provider.

“It’s important to acknowledge Mental Illness Awareness Week because not everyone is equipped to advocate for themselves,” said Allison. “Our efforts to raise awareness of TD should not stop simply because there are available treatment options, such as INGREZZA, we must come together and support each other.”

If you or a loved one is experiencing persistent, uncontrollable movements and have been treated with antipsychotic medication, visit INGREZZA.com for more information.

Important Information

Approved Uses

INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with:

  • movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
  • involuntary movements (chorea) of Huntington’s disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.

Do not take INGREZZA or INGREZZA SPRINKLE if you:

  • are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE.

INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including:

  • Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema.
  • Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE.
  • Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint.
  • Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat.
  • Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls.

Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.

The most common side effect of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness.

The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington’s disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep.

These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules.

Please see full Prescribing Information, including Boxed Warning, and Medication Guide.

* Certain prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders may also cause TD.

† INGREZZA was studied in a 6-week clinical trial. A total of 234 people participated in the study. Results were based on 79 people taking the recommended dose of 80 mg.

‡ In a 6-week clinical study. Post-clinical study evaluation of 149 patients who took 40 mg and/or 80 mg during the first 2 weeks; 64% had at least a 1-point reduction on an uncontrollable movement severity scale.

This article was sponsored and developed by Neurocrine Biosciences, Inc. Allison was compensated by Neurocrine Biosciences to share her story.

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