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

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© 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.

© 2024 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-3972 10/2024

Heart disease isn’t just a man’s disease – everyone should know their risk by taking these 3 simple tests

2024-10-07T06:01:00

(BPT) – Are you concerned about your cardiovascular (CV) health? Even if you don’t have a family history of CV diseases, it’s important to find out if you’re at risk so you can proactively take care of your cardiac health. Luckily, three simple universally available tests can detect your risk of life-threatening CV events like heart attack and stroke — decades in advance.

Since 1950, heart disease has been the leading cause of death in the U.S. While heart disease affects people of all genders, races and ethnicities, heart disease in women, especially young women, has increased, with more women than men dying of heart disease every year.

While these statistics may be shocking, there is good news. A recent study has shown that a simple blood test of three biomarkers can predict a woman’s lifelong risk for heart attack and stroke.

Predicting the risk of CV disease as simple as 1, 2, 3

The recent study published in The New England Journal of Medicine followed nearly 30,000 healthy American women to predict their risk of CV disease over the subsequent 30 years. Researchers measured participants’ levels of high sensitivity C-reactive protein (hs-CRP), LDL cholesterol (LDL), and lipoprotein(a) (Lp(a)). Each biomarker independently contributed to a woman’s overall CV risk, but one stood out above the rest: hs-CRP.

You’re probably familiar with an LDL test and likely Lp(a), which measures fats in your blood. What makes hs-CRP different is that it doesn’t test for fats — but rather for inflammation.

Inflammation’s role in CV disease

It may sound odd that inflammation, your body’s natural response to illness or injury, can contribute to CV events, but if you think about inflammation’s health role, it’s easy to see why.

Cholesterol and plaque in your arteries can also trigger an inflammatory response, according to Johns Hopkins Medicine. When you suffer from long-term inflammation, it can damage healthy tissues, including your arteries and heart.

By measuring your hs-CRP levels, you’ll have a clearer picture of your risk of CV events down the road. In fact, according to another study, among patients already taking cholesterol-lowering statins, hs-CRP may be an even stronger predictor of future CV events than measuring high LDL cholesterol.

“Our understanding of how increased levels of inflammation can interact with lipids to compound cardiovascular disease risks has significantly improved our ability to treat patients based on their individual inflammatory risk which we can now treat with low-dose colchicine,” said Brittany N. Weber, M.D., Ph.D., director of the Cardio-Rheumatology Clinic, and associate physician in preventative cardiology and cardiovascular imaging at Brigham and Women’s Hospital. “This new study shows the importance of measuring the inflammatory biomarker, hs-CRP, in addition to fats in the blood, to be able to better treat our patients, especially women, even earlier and potentially prevent life-threatening heart events.”

A low-dose treatment option for inflammation

Many statin medications have some anti-inflammatory properties but do not fully address inflammation issues. To help manage your inflammation and lower your risk of CV events, you’ll need an anti-inflammatory medication that can further reduce your risk of a heart attack or stroke.

If your hs-CRP levels are high, your doctor may recommend low-dose colchicine. Low-dose colchicine, 0.5 mg, is the first and only therapy FDA-approved as an anti-inflammatory medication shown to reduce the risk of a cardiovascular event, including heart attack or stroke.

The once-daily oral tablet can be used alone or in combination with a patient’s current lipid-lowering medication to effectively treat cardiovascular disease. Low-dose colchicine addresses your inflammatory risk to reduce the risk of a heart attack or stroke in secondary and primary prevention.

If you’re concerned about your heart health, ask your doctor about the three simple tests above and take special notice of your inflammation marker. Learn more about your risk and steps you can take to support your cardiac health at CVDInflammation.com.

Don’t just age, age better: 5 longevity tips for healthier aging

2024-10-04T06:01:00

(BPT) – Do you know how well you’re aging? Aging well goes beyond how you look. To live a healthier, more active lifestyle as you age, it’s important to know your current health baseline and identify potential future issues that you can prevent or manage now.

As we hit the home stretch of 2024, get a jump on next year’s resolutions and be your own health advocate. Create a personalized healthy aging plan with the help of next gen services, like genetic sequencing, and knowing your body’s “true” biological age.

Don’t know where to start? Here are five proactive steps you can take to invest in your health and longevity.

1. Find your baseline

While knowing your family medical history is a great place to start, you’ll need more information to determine your baseline health.

Consider signing up for 23andMe’s Total HealthTM, a longevity platform that combines genetic testing, blood biomarker testing, Biological Age analysis, and expert clinician oversight.

Total Health provides advanced, clinician-ordered genetic testing called exome sequencing that evaluates high impact genes associated with health conditions that, if detected early, may have effective preventive measures and clinical interventions.

Nothing is more personalized than your genetics, and genetic screening really is for everyone (not just for a specific group of people), especially with the amount of information current testing provides. Genetics is a true foundation of health, and the information gleaned from your DNA can offer a lifetime’s worth of insights into your longevity.

2. Go beyond routine lab tests

Once you have genetics as a baseline, you can layer on more data to get a fuller picture of your health profile.

Traditional blood testing does provide important health information. However, frequent comprehensive blood tests can offer ongoing insight into prevention and early detection. In fact, 70% of clinical decisions rely on lab data — that’s why blood testing is so fundamental.1

A comprehensive test can measure things like blood sugar levels, kidney, liver and thyroid function, along with cholesterol and advanced lipoprotein levels. This is especially important if you have a family history of cardiovascular diseases.

Knowing your cholesterol level is just part of the story. When you have a comprehensive blood test, you can find out your lipoprotein(a) (Lp(a)) and Apolipoprotein B (ApoB) levels. High levels of Lp(a) and APOB are associated with an increased risk of heart and blood vessel disease, including heart attacks and stroke.

If you have high levels of either (or both) markers, your health care provider can recommend treatments and lifestyle changes that can help you manage these levels and reduce your risk of related conditions.

Having both genetic and blood biomarker data together is key to constructing your health baseline. Together, they can help you identify screening, treatments and lifestyle changes that promote longevity and build long-term resilience.

3. Combine your genetic results with your bloodwork and take action

Genetics is about future risk. Lab tests are about the now.

Having both genetic and blood biomarker data together is key. Your genetic data gives you deep insights into your potential future risks, while your biomarker data gives you insight into the now. And together they could help provide you with answers.

For example, if you have high cholesterol today, you might be wondering why. Is it your daily habits, or is there more to it? Your genetics could help piece it all together and provide insight into why you may have higher cholesterol beyond your lifestyle habits. In fact, you might have a higher likelihood based on your own genetics! And you might need personalized interventions.

Your genetic test results can also guide you toward concrete steps to prevent disease related to a genetic variant. Genetics can provide insights on potential serious health risks for hereditary cardiovascular disease, neurological disease, and different types of cancers — risks you may not know otherwise. Take, for example, a variant in the MLH1 gene that causes Lynch syndrome.

Lynch syndrome affects about 1 in 280 people and can have serious health consequences. Individuals with Lynch syndrome are at a greater risk of colorectal, endometrial, ovarian and certain other cancers than the general population.

If your genetic results indicate you have Lynch syndrome, you can take proactive steps to manage your cancer risks. For example, the U.S. Centers for Disease Control and Prevention recommend that people with Lynch syndrome should have colonoscopes starting at age 20-25 (instead of waiting until age 45) and continue to get screened every 1-2 years. Earlier, more frequent screening can catch the disease at the beginning stages when it’s most treatable.

4. Make lifestyle changes to lower your biological age

Your age is just a number. It doesn’t tell you how your body is truly aging. That’s why it’s critical to find out your biological age number and potentially lower or maintain your biological age.

23andMe’s Total Health membership includes access to a new Biological Age feature. This feature can help tell you how old you really are from the inside by analyzing biomarkers that reflect the condition of major body systems and organs and how it may differ from your calendar age. This measure is checked biannually so you can track it and take steps to potentially slow down or even reverse course if your biological age is outpacing your calendar age.

5. Make a tailored health plan with a clinician who understands genetics

All of this sophisticated health data is only helpful if you know what to do with it. Once you have your genetic and blood work results, it’s a good idea to work with a clinician to create a tailored health plan that includes lifestyle, screening and other health management tools.

If, for example, you have high cholesterol and elevated Lp(a) levels, a clinician can help you take concrete steps to lower your risk of cardiovascular disease. They might discuss the benefits of statins and how your genetic results can be used to inform what your doctor prescribes to help reduce the risk of side effects.

Finding a clinician may sound daunting, but if you have a Total Health membership, you’ll have unlimited direct access to expert clinicians who have unique training in genetics. They can help connect all of the dots and build a hyper-personalized health plan that focuses on ongoing disease prevention and early detection.

Don’t address health issues as they come along. Get ahead of possible health risks to increase your odds of aging better with these proactive steps. To learn more about genetics, blood testing and personalized care, visit 23andMe.com/Total-Health.

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5759162/

New nationwide notification policy will help women with dense breast tissue

2024-10-03T15:27:00

(BPT) – Have you scheduled your mammogram? If you’re a woman over 40 and haven’t had a mammogram before or are putting off your next one, this is your friendly reminder to schedule it now. Doing so can give you important health information and potentially save your life.

Regular mammograms are the best way to find breast cancer early when it is most treatable. While diagnosis can be scary, catching breast cancer in its earliest, localized stages increases a patient’s 5-year relative survival rate to 99%.

Another benefit of mammograms you may not know about is that they can show if you have dense breast tissue. While dense breast tissue is common, it puts women at a higher risk of developing breast cancer.

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“Mammograms remain the gold standard for detecting breast cancer,” said Michele Brands, MD, Network Director of Women’s Imaging at St Luke’s University Health Network. “But the reality is that dense breast tissue and cancer appear white on mammograms, so the dense tissue can hide the cancer.”

After years of varying policies across the United States, the U.S. Food and Drug Administration (FDA) recently announced a new nationwide reporting standard for breast density notification. As of September 10, 2024 all patients must be informed about their breast density.

With this knowledge, women can then ask their doctors about supplemental imaging options that could make a big difference in early detection of breast cancer.

Your breast health toolbox

Traditional 2D mammograms have a reputation for being uncomfortable and anxiety-producing. However, advancements like GE HealthCare’s Senographe Pristina with Dueta make the screening less scary and put women in the driver’s seat of their mammogram.

Should a mammogram reveal you have dense breast tissue, you may need more detailed 3D imaging screenings, like an automated breast ultrasound, which is specifically designed for detecting cancer in dense breast tissue, or magnetic resonance imaging (MRI). When results remain inconclusive, another tool that may be recommended is contrast-enhanced mammography (CEM) which uses an injected dye to examine breast tissue and flag abnormalities with high levels of sensitivity and specificity.

These screening tools have been invaluable to Dr. Brands and her team at St. Luke’s One-Stop Clinic for Breast.

“Utilizing these tools has been amazing and it’s really helped us with the One-Stop Breast Clinic to create this rapid diagnostic approach for women and bring them through the process as quickly as possible,” said Brands. “One woman may have dense breast tissue, and another may not. The presence of dense tissue is going to inform the process and help you get very personalized care.”

Personalized breast care is critical. Take advantage of the different tools available to get the answers clinicians and their patients deserve. To learn more, visit GEHealthCare.com.