Category: Brandpoint Health

2024-12-11T16:19:00

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

Cerebral palsy (CP) is a neurodevelopmental disorder affecting movement and posture that begins in early childhood development. It is the most common cause of motor disability in children, affecting about one in 345 children in the United States.^1-2 It may happen as a result of lack of oxygen during or around birth, stroke, infection, a problem with metabolism or other problems that cause injury or affect the development of parts of the brain involved in movement control in the first few years of life.³ CP is a permanent condition, affecting a person for their entire life.

People living with CP typically have motor problems, which may include spasticity (abnormal muscle tightness), dyskinesia (uncontrolled movements) or ataxia (poor muscle control), and many people have a mix of these motor disorders.⁴ Dyskinesia due to CP (DCP) is one of the most disabling forms of CP and impacts approximately 10% to 20% of people living with CP.^5-6

According to the Cerebral Palsy Foundation (CPF), the combination of irregular and unpredictable movements (chorea) and twisting and repeating movements (dystonia) often disrupt activities and cause significant functional impairment, including the ability to maintain balance, walk or fine motor control.⁷ Heather Riordan, M.D., Neurologist and Movement Disorders Specialist, Director of the Phelps Center for Cerebral Palsy at the Kennedy Krieger Institute, discusses the symptoms of chorea and impact on patients in a video shared on the CPF website here.

About 30% of people with DCP are affected mostly by these involuntary and irregular movements (chorea), while dystonia is the predominant motor finding in the remaining 70%.⁸ However, it is common for both chorea and dystonia movements to be present together.⁶

For people living with DCP, these movements can occur in any region of the body, including the arms and legs, torso and face and may vary in severity. They are often triggered or made worse by stimulation or stress. Because dyskinesia can occur at rest and/or when actively using the body, the problems with movement are very burdensome in day-to-day living, with discomfort and pain affecting the quality of life for people and their caregivers.⁹

Jen Lyman, mom to a son with DCP, highlights how dyskinesia makes communicating more difficult. “The most difficult thing about dyskinesia is watching my son struggle to do things that he wants to do, but the extra movements get in the way…special things, such as using a touch screen to video chat with his grandmother, are nearly impossible despite his best efforts to use his hands and fingers. Something so simple, yet so special for him should be effortless.”

DCP has a wide-ranging impact on the individual, including lifelong challenges with movement, a higher risk of other medical issues, a higher rate of mental health challenges and difficulties with communication.^10-12

“Those of us who have the privilege to serve patients with dyskinetic, hyperkinetic or mixed cerebral palsy see the functional impact of this very challenging type of tone every day,” said Susan Biffl, M.D., Rehabilitation Medicine Specialist at Rady Children’s Hospital-San Diego and Assistant Professor at UC San Diego School of Medicine. “Patients face challenges with self-care, independence, mobility, communication, fine motor skills that affect occupational and recreational activities, swallowing, social interactions and even sleep. As this tone is variable, it is much more challenging to treat than more consistent tone issues, such as spasticity.”

Treatment Options

There are currently no Food and Drug Administration-approved treatments for DCP. Dystonia and chorea are often managed separately as they respond differently to various treatments, which can make treatment challenging.³ Most drugs being investigated for DCP have focused on dystonia, and more research is needed to determine potential treatments for chorea. New treatment options are needed to help manage these movement disorders and improve daily function and quality of life for those affected.

“After 20 years of caring for individuals with cerebral palsy, I continue to find those with dyskinetic cerebral palsy among the most challenging to treat, largely due to the limited effectiveness of available pharmacologic options,” said Joyce Oleszek, M.D., Professor, Department of Physical Medicine and Rehabilitation, University of Colorado School of Medicine. “There is an urgent need for more robust evidence to support pharmacologic treatments for this condition, given its profound impact on function, comfort and quality of life.”

Ongoing Research

Clinical studies are important in the development of treatment options, allowing researchers to evaluate the safety and effectiveness of new medicines. The data from clinical studies are used to determine if an investigational treatment can be approved for use to treat certain disorders.

There are ongoing clinical studies evaluating potential treatments for DCP, including one for chorea. Neurocrine Biosciences is conducting the KINECT^®-DCP clinical study, a Phase 3, randomized, double-blind placebo-controlled study investigating the study drug, valbenazine, for the treatment of DCP. The clinical study is currently enrolling children, adolescents and adults six to 70 years of age who have been diagnosed with DCP.

“The Cerebral Palsy Foundation is excited to partner with Neurocrine Biosciences on this study,” said Rachel Byrne, Executive Director of the Cerebral Palsy Foundation. “We are proud to support strong research that can potentially bring meaningful change to the lives of those living with cerebral palsy.”

If you or someone you know may be eligible for this research study, please visit the study website for additional information here: FindADCPStudy.com.

REFERENCES

1. Krigger KW. Cerebral palsy: a review. Am Fam Physician. 2006;73(1):91-100.
2. Michael-Asalu A, Taylor G, Campbell H, Lelea LL, Kirby RS. Cerebral palsy: diagnosis, epidemiology, genetics, and clinical update. Adv Pediatr2019;66:189-208. doi:10.1016/j.yapd.2019.04.002
3. Monbaliu E, Himmelmann K, Lin JP, et al. Clinical presentation and management of dyskinetic cerebral palsy. Lancet Neurol. 2017;16(9):741-749. doi:10.1016/S1474-4422(17)30252-1
4. Christine C, Dolk H, Platt MJ, Colver A, Prasauskiene A, Krägeloh-Mann I; SCPE Collaborative Group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev Med Child Neurol Suppl. 2007;109:35-38. doi:10.1111/j.1469-8749.2007.tb12626.x
5. Lumsden DE, Crowe B, Basu A, et al. Pharmacological management of abnormal tone and movement in cerebral palsy. Arch Dis Child. 2019;104(8):775-780. doi:10.1136/archdischild-2018-316309
6. Monbaliu E, de Cock P, Ortibus E, Heyrman L, Klingels K, Feys H. Clinical patterns of dystonia and choreoathetosis in participants with dyskinetic cerebral palsy. Dev Med Child Neurol. 2016;58(2):138-144. doi:10.1111/dmcn.12846
7. Dyskinetic cerebral palsy. Cerebral Palsy Foundation. Published December 20, 2022. Accessed October 29, 2024. https://cpresource.org/understanding-cerebral-palsy/types-cerebral-palsy/dyskinetic-cerebral-palsy
8. Himmelmann K, Hagberg G, Wiklund LM, Eek MN, Uvebrant P. Dyskinetic cerebral palsy: a population-based study of children born between 1991 and 1998. Dev Med Child Neurol. 2007;49(4):246-251. doi:10.1111/j.1469-8749.2007.00246.x
9. Masson R, Pagliano E, Baranello G. Efficacy of oral pharmacological treatments in dyskinetic cerebral palsy: a systematic review. Dev Med Child Neurol. 2017; 59:1237-1248. doi:10.1111/dmcn.13532
10. What is cerebral palsy? Cerebral Palsy Foundation. Accessed November 13, 2024. https://cpresource.org/topic/what-cerebral-palsy
11. Adults & adolescence. Cerebral Palsy Foundation. Accessed November 13, 2024. https://cpresource.org/topic/adults
12. Communication. Cerebral Palsy Foundation. Accessed November 13, 2024. https://cpresource.org/topic/communication

© 2024 Neurocrine Biosciences, Inc. All Rights Reserved. CAP-NBI-US-0115 12/2024
NBI-98854-DCP3018_11DecMatRelease_v1.0_25November2024

2024-12-11T15:05:00

(BPT) – Sponsored by Boston Scientific

Enlarged prostate, also known as benign prostatic hyperplasia (BPH), is a common condition that affects about 50% of men by age 60 and up to 90% of men by age 85.¹ As men age, the prostate can grow from the size of a walnut to about the size of a lemon, placing pressure on the urethra and obstructing the flow of urine.¹ While enlarged prostate (BPH) can be a burdensome condition, it is non-cancerous and there are several treatment options available.²

What are the early signs of enlarged prostate and common symptoms?

Symptoms of enlarged prostate vary and tend to worsen over time. Common symptoms of enlarged prostate include frequent and urgent urination, trouble starting a urine stream, urinary retention, urinary incontinence and more.² Interestingly, the size of the prostate doesn’t always determine how serious symptoms are. For instance, some men with slightly enlarged prostates can experience major symptoms, while others with very enlarged prostates can experience minor symptoms.³ Less frequent but serious symptoms to watch out for include urinary tract infection, not being able to pee and blood in the urine.³

Is there a way to treat enlarged prostate? What are some common treatment options?

It is important to discuss treatment options with a health care provider as soon as symptoms begin.³ While there isn’t a cure for enlarged prostate, a range of treatment approaches can help alleviate symptoms, including:

• Watch and wait: Closely monitoring the condition is the first consideration for most men presenting with early signs of enlarged prostate. Some men will also turn to behavioral modifications such as drinking less caffeine to avoid worsening symptoms.⁴
• Medication: Another way of treating enlarged prostate is through commonly prescribed medications that can relax the tension on your urethra making it easier to urinate. Other medications block hormones, which in turn can slow the growth of the prostate gland.⁵
• Surgery: In instances where medications are ineffective or patients wish to avoid daily pills and their associated side effects, symptoms are severe or complications arise, health care providers may recommend surgery to remove the tissue around the urethra or widen the urethra itself.⁵

Are there alternatives to surgery?

For those who want to avoid surgery, there are minimally-invasive treatment options, like Rezūm™ Water Vapor Therapy — a short, in-office procedure requiring no general anesthesia.⁶ The procedure uses water vapor, or steam, to remove obstructive prostate tissue over time — helping reduce the symptoms of BPH.⁷

Most patients return to their regular activities within a few days and see improvement in their symptoms over a few weeks. Research has also shown that Rezūm provides patients with significant and sustained BPH symptom relief through 5 years.⁶

Graphic depicts how Rezūm Water Vapor Therapy affects the prostate.

To learn more about Rezūm Water Vapor Therapy and to find a doctor near you, please visit https://www.rezum.com/find-a-doctor.html/.

As with any medical treatment, there are some risks which include painful or frequent urination, blood in the urine or semen, decrease in ejaculatory volume, urinary tract infection (UTI), inability to urinate or completely empty the bladder and urgent need to urinate. Visit Rezum.com for a complete list of risks and talk to your doctor about the benefits and risks associated with Rezūm.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

All treatments have inherent and associated risks. The Rezūm System is intended to relieve symptoms, obstructions and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume 30cm3 ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. Potential risks include but are not limited to painful urination (dysuria), blood in the urine (hematuria), blood in the semen (hematospermia), decrease in ejaculatory volume, suspected urinary tract infection (UTI), and urinary frequency, retention or urgency. You should talk with your doctor about benefits and risks before moving forward with any treatment option.

All images are the property of Boston Scientific. All trademarks are the property of their respective owners.

References

1. Harvard Health. The growing problem of an enlarged prostate gland. Available at: https://www.health.harvard.edu/mens-health/the-growing-problem-of-an-enlarged-prostate-gland. Accessed December 2024.

2. Health Information. Urologic Diseases. Prostate Problems. Prostate Enlargement (Benign Prostatic Hyperplasia). National Institute of Diabetes and Digestive and Kidney Diseases. Available at: https://www.niddk.nih.gov/health-information/urologic-diseases/prostate-problems/prostate-enlargement-benign-prostatic-hyperplasia#benign. Accessed December 2024.

3. Diseases & Conditions. Symptoms & causes. Benign prostatic hyperplasia (BPH). Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/benign-prostatic-hyperplasia/symptoms-causes/syc-20370087. Accessed December 2024.

4. UpToDate. Patient education: Benign prostatic hyperplasia (BPH) (Beyond the Basics). Available at: https://www.uptodate.com/contents/benign-prostatic-hyperplasia-bph-beyond-the-basics. Accessed December 2024.

5. Diseases & Conditions. Diagnosis & treatment. Benign prostatic hyperplasia (BPH). Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/benign-prostatic-hyperplasia/diagnosis-treatment/drc-20370093. Accessed December 2024.

6. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezūm water vapor thermal therapy for treatment of moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021 Sep;206(3):715-24.

7. McVary KT, Gange SN, Gittelman MC, et al. Minimally invasive prostate convective water vapor energy (WAVE) ablation: A multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2016 May;195(5):1529-38.

2024-12-10T06:01:00

(BPT) – Winter can be a joyous season — full of sledding, skating, skiing and all the other fun and exciting activities that come along with it. But it can also be a season of accidents, and they can happen to anyone, including you, your partner, and especially active kids.

Last year’s report from the U.S. Consumer Product Safety Commission found that activities like skiing, snowboarding, ice hockey, ice skating and sledding caused almost 125,000 visits to the emergency room in one winter alone. Approximately 4,700 snow blower-related injuries were also treated in the ER, and that doesn’t even include all the injuries caused by simply slipping and falling on winter ice.

If an accident happens, are you protected?

Being ready for the unexpected may mean a lot of things, but having access to sufficient financial resources is potentially the most crucial factor of all. Did you know that to help safeguard you and your family when the unexpected occurs, accident insurance can pay you cash benefits, giving you peace of mind in the event of a covered accident?

For example, Boston Mutual Life’s accident insurance is built to help protect you and your family from the unexpected. When a covered accident occurs, such as a broken bone or a concussion, your health insurance plan may cover most of your major expenses, but you could still be left with additional out-of-pocket costs. That may be an opportunity where accident coverage can help cover those additional costs.

How accident insurance works

Thanks to an accident insurance plan, you can get coverage for yourself as well as your spouse and your children (under age 26). In the event of an accident, you’ll have access to an easy claims process, and you’ll receive cash benefits paid directly to you.

What benefits are provided by accident insurance?

While your health insurance may cover some or many of your medical bills, depending on your specific plan’s coverage, it probably won’t cover everything. This is where accident insurance can make a big difference. It can help cover additional things like ambulance rides, emergency room visits, physical therapy, emergency dental work, and more.

Accidents can happen anywhere, at any time

Life can be full of surprises, and unfortunately not all of them are happy surprises. But being prepared — even for the worst — means that you and your family will have better peace of mind should the unexpected occur.

You can find more information about insurance options to provide peace of mind for you and your family by visiting BostonMutual.com.

335-5215 11/24

Policy Series WPS-ACC 07/15

2024-12-09T05:01:00

(BPT) – Your eyes can tell you a lot about your health, and this is especially true for those living with thyroid eye disease (TED). TED occurs when the immune system mistakenly targets the tissues around the eyes, leading to symptoms like swelling, bulging and discomfort. During the active phase of TED, when these symptoms are most pronounced, people often experience redness, pain, and inflammation, which can impact daily life.

TED is commonly associated with Graves’ disease, an autoimmune condition where the immune system attacks the thyroid gland. According to the American Thyroid Association, TED can manifest symptoms such as a gritty sensation in the eyes, light sensitivity, dry eyes, and even double vision. While these symptoms may vary in intensity and can improve over time, some individuals may experience more severe forms that require prescription medication or, in some situations, surgery.

A new investigational drug

In an effort to develop additional drug options for TED, researchers are conducting a clinical trial called the spiriTED study. This study is focused on evaluating an investigational drug, TOUR006, in adults with Graves’ disease whose onset of TED symptoms began in the past 15 months. The goal is to better understand how TOUR006 may work in comparison to a placebo — a substance without any active investigational drug.

How to participate in the spiriTED study

Current treatments for conditions like TED exist thanks to the participation of research study volunteers. If you or someone you know is managing moderate to severe active-phase TED, you might consider joining the spiriTED study to help advance research efforts for yourself and others facing similar challenges.

To be eligible, participants must be between 18 and 80 years old, have been diagnosed with Graves’ disease and are currently experiencing moderate to severe symptoms of TED that began in the last 15 months. Note that this is not a complete list of study eligibility requirements. The study doctor will review the full requirements for this study with you. You may be eligible for reasonable compensation for your time to attend study visits and/or reimbursement for certain approved study-related costs, such as transportation. Your safety is a top priority, and you’ll be monitored throughout the study.

To learn more and see if you qualify, click here to take the next step.

2024-12-06T12:01:00

(BPT) – (In Partnership with Eli Lilly and Company)

Are you forgetting your words or losing your train of thought more than usual? Memory and thinking issues can be easily dismissed as signs of normal aging, though they could point to a more serious disease. Experts believe excessive amyloid plaque buildup may cause changes in the brain that make it difficult to do things such as retain new information, remember important dates or find the right words or names.

According to the Alzheimer’s Association, 6.9 million Americans aged 65 or older are living with Alzheimer’s dementia in 2024. While symptoms may be recognizable, patients may avoid reaching out to their doctors or even hide symptoms due to fear of the stigma associated with Alzheimer’s disease. But Carole, 72, says that not letting herself or others dismiss her symptoms as normal aging was critical to get the diagnosis and help she needed.

“Try to stay positive,” Carole advises folks who notice memory and thinking issues. “Be honest with yourself. There’s help out there, but you have to sometimes seek it out yourself.”

Subtle changes speak volumes

After decades of living, working, and raising kids in Kentucky, Carole and her husband Hank decided to spend their golden years in the Sunshine State. They moved to Punta Gorda, Florida, and have been enjoying retirement there for the past 11 years.

As the years passed by, Hank noticed changes in his wife. Carole began regularly repeating herself without realizing it and misplacing items around their home. Having helped care for his mother and Carole’s, who both faced the challenges of Alzheimer’s disease, he was familiar with some of the early signs and symptoms of the disease. Hank also knew Carole’s family history with the disease meant she had an increased chance of developing it herself.

“All of a sudden, you’re seeing this person is struggling to get some things done that would have just been no big deal,” said Hank. “One of the key things to managing Alzheimer’s disease is recognition. You just have to get in there and be supportive of your loved ones.”

Self-advocacy paves a brighter future

It is estimated that about one-third of people with MCI due to Alzheimer’s disease progress to a later stage within five years. Once Hank recognized the symptoms, he knew it was important to ask Carole’s doctor for a cognitive screening because diagnosing Alzheimer’s disease earlier has the potential to provide an opportunity for advanced care planning in collaboration with your doctor. With the availability of disease-modifying treatments and the potential to slow disease progression, an early diagnosis may allow patients to continue to do the things they enjoy for a longer time.

When Hank gently voiced his concerns about her behavior, the couple decided Carole needed to see her doctor as soon as possible. After a visit to her doctor – who said Carole’s symptoms were normal for her age – Carole began doing additional research. While Carole’s symptoms can be associated with normal aging, she remembered her symptoms were different than her mother’s.

With Hank’s support, Carole continued seeking out testing options and potential therapies. Eventually she was diagnosed with early symptomatic Alzheimer’s disease and was accepted into a late-phase clinical trial for Kisunla™ (donanemab-azbt) injection for IV infusion (350 mg/20 mL). Kisunla is an amyloid-targeting therapy the FDA approved to treat early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia stage of disease) with confirmed amyloid pathology.

“I just thought, wow, I’m so lucky to get into a clinical trial,” Carole said. “And it helped me. It gave me hope.”

SELECT SAFETY INFORMATION

Kisunla can cause Amyloid-Related Imaging Abnormalities, or “ARIA.” ARIA is a common but serious side effect that does not usually cause any symptoms, but can be serious. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Please see Indication and Safety Summary with Warnings below for additional safety information for Kisunla.

Carole’s Treatment Journey

During the 18-month study, Carole and Hank say her cognitive health appeared to remain steady. Carole credits her early diagnosis of Alzheimer’s disease, optimism and hope to her self-advocacy and treatment with Kisunla. In the 18-month study, Kisunla slowed the progression of memory and thinking issues that are due to early symptomatic Alzheimer’s disease compared to placebo.

Kisunla is a therapy that has been shown in clinical studies to reduce amyloid plaques. Kisunla is an important advancement, since doctors can consider stopping Kisunla treatment based on the reduction of amyloid plaques to minimal levels on amyloid positron emission tomography (PET) imaging. That means some patients might not have to go in for infusions for an unlimited period of time*. [*Please note: Kisunla is administered every 4 weeks through IV infusion for 30 minutes. The long-term clinical benefit of Kisunla after stopping treatment has not been studied.]

Today, Carole spends most of her time with family. Carole and Hank have two children, one in Atlanta and one in Baltimore, and two grandchildren. When she isn’t with extended family, Carole largely spends most of her time with Hank at home in Florida or traveling to her favorite destinations like the Great Smokey Mountains.

“Things might be different if I didn’t first admit I had this problem or tried to get help or hadn’t been in the study,” she said.

Don’t ignore the signs

If you or a loved one are experiencing memory or thinking issues, it’s important to discuss these issues with your physician along with the potential for cognitive screening and other tests to help determine if the underlying cause of the memory and thinking issues could be due to early symptomatic Alzheimer’s disease. Learn about treatment with Kisunla by visiting www.kisunla.lilly.com.

Lilly Support Services™ for Kisunla is a free support program committed to help patients navigating treatment with Kisunla. The program includes offerings such as coverage determination assistance, care coordination, nurse navigator support, and customized support and resources. For more information about Lilly Support Services and Kisunla, call 1-800-LillyRx (1-800-545-5979) or visit www.kisunla.lilly.com.

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Kisunla™ (kih-SUHN-lah) is used to treat adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.

Warnings – Kisunla can cause Amyloid-Related Imaging Abnormalities or “ARIA.” This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have:

• Headache
• Dizziness
• Nausea
• Difficulty walking
• Confusion
• Vision changes
• Seizures

Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.

You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.

Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.

There are registries that collect information on treatments for Alzheimer’s disease. Your healthcare provider can help you become enrolled in these registries.

Warnings – Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.

Other common side effects

• Headache

Tell your healthcare provider right away if you have any side effects. These are not all of the possible side effects of Kisunla. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you receive Kisunla, tell your healthcare provider:

• About all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements. Especially tell your healthcare provider if you have medicines to reduce blood clots from forming (antithrombotic medicines, including aspirin).
• About all of your medical conditions including if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed. Kisunla has not been studied in people who were pregnant or breastfeeding. It is not known if Kisunla could harm your unborn or breastfeeding baby.

How to receive Kisunla

Kisunla is a prescription medicine given through an intravenous (IV) infusion using a needle inserted into a vein in your arm. Kisunla is given once every 4 weeks. Each infusion will last about 30 minutes.

Learn more

For more information about Kisunla, call 1-800-LillyRx (1-800-545-5979) or go to kisunla.lilly.com.

This summary provides basic information about Kisunla. It does not include all information known about this medicine. Read the information given to you about Kisunla. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Kisunla. Your healthcare provider is the best person to help you decide if Kisunla is right for you.

DN CON BS APP

Kisunla^™ and Lilly Support Services are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

PP-DN-US-0402 11/2024 ©Lilly USA, LLC 2024. All rights reserved.

References:

1. Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer’s disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;3(8):371-386.
2. Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimers Dement. 2024;20(5)
3. Wessels AM, Dennehy EB, Dowsett SA, et al. Meaningful clinical changes in Alzheimer disease measured with the iADRS and illustrated using the donanemab TRAILBLAZER-ALZ study findings. Neurol Clin Pract. 2023;13(2):e200127. doi:10.1212/CPJ.0000000000200127
4. Kisunla (donanemab-azbt). Prescribing Information. Lilly USA, LLC.
5. Kisunla (donanemab-azbt). Medication Guide. Lilly USA, LLC.

2024-12-06T06:01:00

(BPT) – The holiday season can be a wonderful time — from gathering with family and friends to enjoying some time off work and even indulging in all the yummy treats. The last thing we want is to become sick with illnesses like pneumococcal pneumonia and invasive pneumococcal disease (IPD) and miss out on this joyful time with the ones we love. That’s why it’s important to take a proactive approach when it comes to our health. And fortunately, there are ways to help protect ourselves against certain illnesses so we can continue enjoying all of the magic and festivities this season has to offer.

Here are some ways you can prioritize your health ahead of the holidays:

• Wash your hands regularly: lather on an antibacterial soap to defend against germs
• Eat a balanced diet: try new recipes that focus on getting a proper share of protein and veggies
• Get enough sleep: stop scrolling before bed and ensure you’re getting the amount of sleep you need to feel your best
• Exercise: even if it’s just a walk around the block, moving your body can help you feel better physically and mentally
• Protect yourself from cold weather: break out your favorite scarves and gloves to bundle up in style
• Get vaccinated against pneumococcal pneumonia and invasive pneumococcal disease

Are you 50 or older? The CDC now recommends pneumococcal vaccination for adults 50 and older. 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.

It’s important to know that being 50 or older puts you at increased risk for these illnesses, even if you’re healthy. Those 19 or older with certain underlying medical conditions like diabetes, asthma, chronic heart disease and COPD are also at increased risk. 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 disease previously, your healthcare provider may recommend another vaccination for additional protection.

The holidays are all about being present with our loved ones. So make sure you talk to your doctor or pharmacist about pneumococcal vaccination and visit VaxAssist.com to schedule a vaccination appointment today.

Brought to you by Pfizer.

2024-12-05T13:01:00

BEFORE USING

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

• have adrenal gland problems
• have a tumor in your pancreas
• have not had food or water for a long time (prolonged fasting or starvation)
• have low blood sugar that does not go away (chronic hypoglycemia)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if GVOKE passes into your breast milk. You and your healthcare provider should decide if you can use GVOKE while breastfeeding.

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

HOW TO USE

• Read the detailed Instructions for Use that come with GVOKE.
• Use GVOKE exactly how your healthcare provider tells you to use it
• Make sure your relatives, close friends, and caregivers know where you store GVOKE and how to use it the right way before you need their help.
• Act quickly. Having very low blood sugar for a period of time may be harmful.
• Your healthcare provider will tell you how and when to use GVOKE.
• After giving GVOKE, your caregiver should call for emergency medical help right away.
• If you do not respond after 15 minutes, your caregiver may give you another dose, if available. Tell your healthcare provider each time you use GVOKE. Low blood sugar may happen again after receiving an injection of GVOKE. Your diabetes medicine may need to be changed.

HOW TO STORE

• Keep GVOKE pre-filled syringe and HypoPen in sealed foil pouch until time of use.
• Keep GVOKE kit vial and pouched syringe together in original carton until time of use.
• Store GVOKE at temperatures between 68°F and 77°F.
• Do not keep it in the refrigerator or let it freeze.

Keep GVOKE and all medicines out of the reach of children.

For more information, call 1-877-937-4737 or go to www.GvokeGlucagon.com.

Please see the Full Prescribing Information for Gvoke

References:

1. American Diabetes Association Professional Practice Committee. 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S111-S125. doi:10.2337/dc24-S006.
2. McCall AL, Lieb DC, Gianchandani R, et al. Management of individuals with diabetes at high risk for hypoglycemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2023;108(3):529-562.doi:10.1210/clinem/dgac596.
3. Valentine V, Newswanger B, Prestrelski S, Andre AD, Garibaldi M. Human factors usability and validation studies of a glucagon autoinjector in a simulated severe hypoglycemia rescue situation. Diabetes Technol Ther. 2019;21(9):522-530.

2024-12-04T10:55:00

(BPT) – Tatiana loves hiking, training their service dog, and attending open-mic nights and poetry slams. When Tatiana was unable to stay awake and started falling asleep in college classes, they knew there was something wrong.

The excessive daytime sleepiness that Tatiana was experiencing was diagnosed as narcolepsy. Narcolepsy is a rare neurological disorder that can affect all aspects of a person’s daily life, including fighting to stay awake throughout the day, falling asleep without warning, or feeling sleepy in situations that are less active such as watching TV or riding in a car. It is estimated that 170,000 people in the United States live with narcolepsy.

Asim Roy, MD, who is the Medical Director of the Ohio Sleep Medicine Institute and a board-certified sleep specialist and neurologist, said, “Narcolepsy is often undiagnosed or misdiagnosed. Many people experience symptoms of narcolepsy for years before receiving an accurate diagnosis of narcolepsy.”

Living with narcolepsy and common misconceptions

All people living with narcolepsy experience excessive daytime sleepiness, which is defined as the inability to stay awake and alert during the day or the persistent feeling of tiredness. For Tatiana, excessive daytime sleepiness was being unable to stay awake in sedentary situations like sitting down in class or waiting for appointments, which became a very big obstacle.

“Unfortunately, there are several misconceptions about people living with narcolepsy, many of which are not true. Narcolepsy symptoms can be hard for others to fully understand; therefore, people living with narcolepsy can experience stigma as a result of this,” Dr. Roy explained. “Although we all get tired, people living with narcolepsy feel an overwhelming sense of sleepiness and have to fight to stay awake and alert throughout the day, and may even fall asleep without warning,” he added. “This can be hard for people because of the impact it can have not only on their own daily life, but also their relationships with others.” Dr. Roy added, “Their excessive daytime sleepiness can cause them to withdraw socially and arrive late or fully miss events, which can further lead to strained relationships if not understood by others.”

Searching for treatment options

Tatiana first learned about WAKIX^® (pitolisant) by doing their own research and was first interested in WAKIX because it’s not a stimulant. Tatiana was excited to talk to their healthcare provider to learn more about WAKIX and if it might be a good option for them. They asked their healthcare provider, and he explained possible side effects and set expectations for getting started on treatment. After Tatiana’s healthcare provider explained how to get started on treatment, including the titration period, and the importance of communication particularly during the first couple months, they started WAKIX in 2019.

“When I prescribe WAKIX to a patient, I make sure I set their expectations for getting started, including the titration period and that it might take up to 8 weeks for them to achieve a response,” Dr. Roy noted. “I start patients at a low dose and then may increase their dose each week until we get to the right dose for them.” Dr. Roy added, “WAKIX is thought to work differently through histamine levels in the brain.”

“It’s important that I inform my patients that WAKIX is not a stimulant and let them know that the way their body feels when taking WAKIX may be different from medications they’ve taken in the past,” Dr. Roy explained. “I also discuss the potential side effects, which, for adult patients, the most common are insomnia, nausea, and anxiety. I also mention other potential side effects and things they can expect while on treatment,” explained Dr. Roy. “I emphasize the importance of communicating with me as they are starting on treatment so we can discuss how they’re feeling, what improvements they’re seeing, and what side effects they might be experiencing. I also go over any questions they might have for me.”

Importance of support and community

Tatiana started to notice WAKIX was working when they had more wakefulness throughout the day and “weren’t falling asleep as uncontrollably as often.” Since they started taking WAKIX, Tatiana noticed that they were feeling less sleepy when riding in a car. “When I went on a road trip with my girlfriend, I was actually able to stay awake and have conversations with her,” shared Tatiana. They also felt less sleepy when doing activities they enjoy, like writing, reading, painting, and hiking. In August 2024, Tatiana had their poetry book titled “Wild Brujeria” published. In this book, Tatiana wrote about their life and has written multiple poems about living with narcolepsy.

Tatiana mentioned how the support of others in the narcolepsy community has also helped them through their journey and provided a source of hope and interpersonal support. “I show up and can help support people on my good days, and I can be supported on my bad days. Narcolepsy, it’s an up and down kind of thing…no one day looks the same. And it’s just having a community of people that understand and can support me and accept me, it’s been invaluable to my life, and I hope to pay it forward. Living with narcolepsy isn’t always easy. But for now, I’m thankful to have a treatment plan that is right for me,” Tatiana 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 Tatiana 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.

2024-12-04T08:01:00

(BPT) – For more than a century, Johnson & Johnson has been synonymous with innovation in science and medicine by moving the needle in building a world where complex diseases are prevented and cured, treatments are smarter, and solutions are personalized and accessible. Inventions like robotic surgery, tissue engineering, and treatments for cancers and HIV have changed the world forever and improved the patient experience and health and care for all.

As an authority on transformative scientific research and discoveries, Johnson & Johnson recognizes the impact scientific research and discoveries can have on the world and is proud to celebrate those innovations — both inside the company and from other scientists around the world — through two awards: the Johnson Medal and the Dr. Paul Janssen Award.

Established in 1960, The Johnson Medal is Johnson & Johnson’s most prestigious company-wide honor and celebrates trailblazing innovation in research and development. The Medal is awarded to teams who exemplify excellence through their curiosity, impactful contributions to patients, collaborative spirit, and unwavering commitment to pushing boundaries and making breakthroughs that accelerate science through novel healthcare solutions.

Johnson & Johnson employees who have previously received this honor include:

• Jill Giles-Komar, David Shealy, Jacqueline Benson, Yevgeniya Orlovsky, Jeffrey Luo and Carrie Brodmerkel, the team that developed a treatment for plaque psoriasis which has since been approved for irritable bowel diseases and psoriatic arthritis
• Dr. Assaf Govari, a four-time winner who created several medical technological devices, including an ultrasound that provides real-time, 3D imaging of the inside of the heart
• Jordan Schecter, Arnob Banerjee, Jean Xu, Jennifer Yohrling, Loreta Marquez and Ravi Bhatia for developing J&J’s first CAR-T cell therapy for treating multiple myeloma
• Thorsten Siess, Claudia Mourran, Frank Kirchhoff, Jimpo Wang, Scott Corbett, Vincent Roy and Werner Carell who developed the only heart pump to help restore native heart function during surgery or following a heart attack

Passionate and creative scientists are all around us and in an effort to celebrate the impact these gifted researchers can have on transforming human health and inspiring others, Johnson & Johnson also honors a scientist or research team whose achievements have made a measurable impact on health for all with the Dr. Paul Janssen Award for Biomedical Research.

Established in 2004, this award honors the memory of Dr. Paul Janssen, a passionate, prolific scientist and researcher who discovered over 80 treatments — four of which remain on the World Health Organization’s list of essential medicines — for many illnesses, including infectious diseases, pain, and psychiatric disorder. The Award extends the legacy of its namesake and lauds groundbreaking biomedical researchers outside of Johnson & Johnson who have made “a transformational contribution toward the improvement of human health.” More than a third of this award’s winners have received a Nobel Prize for their foundational work.

Counted among the award’s recipients are:

• Dr. Emmanuelle Charpentier and Dr. Jennifer Doudna for their co-discovery of a new method for precise genetic information manipulation
• Dr. Erik De Clercq and Dr. Anthony Fauci for their work in understanding and combatting viral diseases, particularly HIV/AIDS
• Dr. Robert Langer for his development of novel drug delivery systems that have revolutionized treatment for a number of diseases and chronic conditions
• Dr. Lynne Maquat and Dr. Alexander Varshavsky for their fundamental discoveries about regulated degradation of RNA and proteins

Johnson & Johnson is committed to honoring scientific creativity and excellence that can improve the lives of patients around the world. These awards aim to inspire future generations of scientists and researchers to continue to push boundaries through cutting-edge science and transformative healthcare solutions while honoring the legacies of the pioneers who came before. Johnson & Johnson knows that recognizing and supporting innovation — wherever it originates — is key to advancing medical discoveries. As Dr. Paul would say, “There is so much more to be done; the patients are waiting.”

2024-12-04T08:01:00

(BPT) – Every year, nearly half a million people in the U.S. suffer from a serious and potentially deadly infection called Clostridioides difficile or C. diff.^1,2 C. diff is a bacteria that can overwhelm good bacteria in the gut and cause an infection. Symptoms may include constant diarrhea, stomach pains, and fever.¹ Even when treated with antibiotics, a C. diff infection can come back again and again.¹

Imagine having C. diff and needing to be close to a bathroom almost constantly – it can make even the simplest task like going to the grocery store difficult.¹ That’s what happened to Heather, a 37-year-old newlywed from Arizona.

Heather recalls her fear when she began going through a vicious cycle of symptoms right before her wedding. “I had dreamed of being this beautiful princess bride, and suddenly I was sick all the time. It was devastating.”

Heather was initially treated with antibiotics, but her infection returned. This is common for some C. diff sufferers. Up to three in 10 people who have C. diff get it again, which is known as a recurrence.^2,3 After a first recurrence, up to six in 10 people may develop a subsequent recurrence. ^4,5

When Heather visited her doctor for a follow-up, she learned about an option called REBYOTA, the first and only single-dose microbiome-based therapy approved by the U.S. Food and Drug Administration (FDA) to prevent recurrent C. diff infection in individuals 18 years of age and older following antibiotic treatment for recurrent C. diff infection. REBYOTA is delivered directly where it’s needed, the gut microbiome.

“I went in, and my nurse administered REBYOTA. It only took about 15 minutes, and then I was able to get up and drive myself home,” she said.

A few days after the administration, Heather started to notice a difference.

“I was so surprised. The number of times I was rushing to the bathroom decreased, and each day I felt incrementally better,” she said. “After being sick for so long, I was finally starting to feel like myself again.”

More than six months later, Heather remains free of C. diff symptoms. She even felt well enough to go to the Phoenix State Fair with her husband. “We were there from morning until night, and I didn’t have to worry about being close to a bathroom. It was something I never thought would be possible when I was sick,” she said. Individual results may vary.

To learn more about C. diff infection and REBYOTA, talk to your doctor and visit REBYOTA.com.

INDICATION

REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.

Limitation of Use
REBYOTA is not indicated for the treatment of C. diff infection.

Important Safety Information

• You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components.
• You should report to your doctor any infection you think you may have acquired after administration.
• REBYOTA may contain food allergens.
• Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
• REBYOTA has not been studied in patients below 18 years of age.
• Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088.

Please click to see the full Prescribing Information.

References:

1. Centers for Disease Control and Prevention. About C. Diff? 6 Mar. 2024. Available at: https://www.cdc.gov/c-diff/about/index.html.
2. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(9):825-834.
3. Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012;55(suppl 2):S154-S161.
4. Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18(suppl 6):21-27.
5. Smits WK, Lyras D, Lacy DB, Wilcox MH, Kuijper EJ. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020.

Photo by Julian Dufort