Navigating chronic migraine: One woman’s quest to find the right doctor and preventive treatment

2024-06-11T14:01:00

(BPT) – As a nursing student, Nicole, 32, has a busy yet rewarding life. She works 12-hour hospital shifts as a nursing assistant and spends her free time traveling and playing with her dogs, Bailey and Snoopy. She’s also lived with the invisible, excruciating pain and complexities of migraine disease since she was a child.

Migraine Impact: It’s More Than a Headache

At age 11, Nicole began experiencing pain and sickness, symptoms that she would later learn were that of migraine disease. Unfortunately, Nicole’s path to diagnosis mirrors one many migraine patients experience — years of doctors overlooking her symptoms, delaying her diagnosis and treatment for over a decade — until she finally received a chronic migraine diagnosis in her mid-20s. There are over 150 different classifications of headache disorders and a myriad of associated symptoms, so it is important to seek out a neurologist, who understands the impact migraine can have on someone’s life, when experiencing migraine symptoms.

Becoming empowered and confident in advocating for herself came slowly for Nicole. In her years searching for an effective treatment, Nicole’s migraine disease became more severe and the stress of being a full-time student and part-time employee seemed to increase her vulnerability to migraine attacks. She was no longer able to function at work, spend time with her friends or do any of the other activities she previously enjoyed.

“I went from having the typical life of a young working professional to dealing with debilitating migraine attacks with nausea, vomiting and fatigue,” says Nicole. “I lost friends, my job, and my financial and physical independence.” She tried multiple medications and lifestyle changes to reduce her symptoms, but the migraine attacks persisted.

After unsuccessful treatments, Nicole learned about VYEPTI® (eptinezumab-jjmr), a prescription medicine used for the preventive treatment of migraine in adults, by way of various talks she attended during her advocacy work. She began researching more about the treatment, its clinical trials, and its route of administration — she was intrigued by the intravenous (IV) infusion treatment delivery that’s given by a healthcare professional every 3 months. She wondered if it could be a good fit for her and wanted to try it, so she brought it up with her doctor. They discussed the treatment, its benefits and risks, and based on their clinical judgement, Nicole’s neurologist decided to prescribe it for her.

“I am in a much better place,” said Nicole. “If my migraine wasn’t well managed, my 12-hour shifts in the hospital would feel unbearable.” Since starting preventive treatment on VYEPTI, Nicole is able to spend less time managing her migraine and more time enjoying school, work and life. “I never would have imagined that I could enjoy trips like the one I recently took to Portugal.”

VYEPTI is a calcitonin gene-related peptide antagonist (anti-CGRP) and is the first and only FDA-approved preventive treatment for migraine delivered by IV infusion. In patients with four or more migraine days per month, VYEPTI has been proven to reduce average monthly migraine days over months 1-3 compared to placebo. Individual results may vary.

Do not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. See additional Important Safety Information for VYEPTI below.

A New Chapter with Migraine Under Control

When Nicole moved from New York to Chicago, she found it difficult to connect with a doctor who did not dismiss her debilitating symptoms. She visited four different doctors but none of them were the right fit for her.

“I didn’t feel heard or respected with some of the doctors,” said Nicole. “One wanted to change the treatment plan that was working for me. And others weren’t comfortable with my medical profile, which is complex and comes with comorbidities.”

Given Nicole’s struggle to feel connected with a new healthcare partner in Chicago, and her happiness with the two-way partnership and treatment experience with her doctor in New York, she chooses to travel from Chicago to New York for her quarterly VYEPTI infusion treatments. Nicole’s New York-based doctor, a migraine and headache specialist, recognizes the disabling nature of the disease, respects what she says about the impact of symptoms on her daily activities, and values her input. This collaborative and supportive partnership is essential to Nicole’s health and well-being.

Nicole wants to share what she’s learned from her migraine experience, and why she thinks it’s important to not give up on finding the right treatment and doctor.

Power of Self Advocacy

When managing your migraine disease, Nicole emphasizes the importance of advocating for yourself.

“If you’re not satisfied with the level of control you have over your migraine symptoms on your current treatment, or aren’t connecting with your doctor, consider making a change. You shouldn’t feel like you’re a burden for asking for better options to meet your treatment goals,” advises Nicole. “It’s important to ask about alternatives to help prevent your migraine attacks, especially if they are affecting your daily life.”

There are resources available to those seeking more information about treatment options, Nicole notes. Migraine organizations, such as National Headache Foundation and American Migraine Foundation, serve as valuable community resources helping to educate patients, healthcare professionals and the public on migraine and headache disorder symptoms, advocacy efforts, support for treatment research, and offer tools to locate a headache specialist. While there is a higher concentration of specialists in larger cities, many of which are in high demand, the emergence of telehealth is helping to expand access to specialists for people not located near these city hubs.

Another key part of managing migraine is prioritizing a positive and supportive partnership with your doctor. Nicole urges people living with migraine to ask the following questions when meeting with a/their doctor:

  • Can I communicate with you outside of appointments?
  • How easy will it be for me to get an appointment in the event of an emergency?
  • What treatment options could help me better manage my symptoms so I can continue doing things I enjoy?
  • Are there alternative options I have not tried yet that can help me manage my migraine disease with my comorbidities?
  • Are there any new advancements in migraine and headache treatments?

Nicole wants others to feel inspired by her experiences. She encourages everyone with migraine to speak up, especially if they feel they are still highly impacted by migraine or if they are not feeling heard by their doctor. “You can still do a lot with migraine and all the symptoms. Sure, you can have horrible days. We all have horrible days. But there’s always hope with preventive treatment to have more good days. Now there are some days when I completely forget I have migraine, and those are the best days of all.”

To learn more about how you can personalize your next treatment discussion with your doctor, visit vyepti.com.

APPROVED USE

VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Do not receive VYEPTI if you have a known allergy to eptinezumab-jjmr or its ingredients.

VYEPTI may cause allergic reactions. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction: rash; swelling of your face, lips, tongue, or throat; if you have trouble breathing; hives; or redness in your face.

Before starting VYEPTI, tell your healthcare provider about all your medical conditions, including if you are pregnant or plan to become pregnant, or you are breastfeeding or plan to breastfeed.

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

The most common side effects of VYEPTI include stuffy nose and scratchy throat, and allergic reactions.

These are not all the possible side effects of VYEPTI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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.

For more information, please see the Prescribing Information and Patient Information or go to vyepti.com.

© 2024 Lundbeck. All rights reserved. VYEPTI is a registered trademark of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-101499

Amazon is Building the Future of Pharmacy: A Guide to Affordable, Convenient Care

2024-06-10T16:03:00

(BPT) – In the U.S., more than 131 million people (about 66% of adults) use prescription medications to maintain their health and well-being. However, these customers can face significant difficulties accessing and affording their medication. From waiting for hours in line at the pharmacy to questions of privacy to surprise costs, the traditional pharmacy model is not built with customers in mind. These barriers can make accessing potentially life-saving medication difficult, if not impossible, for some patients.

Rethinking the pharmacy experience

Why is getting prescription medication so difficult? Traditional pharmacies have remained largely unchanged for decades, not adapting to modern customer needs. This has led to pain points that include reduced hours, fewer pharmacists, and inflated prices, which worsen the pharmacy experience.

Luckily, new innovations are changing the prescription drug landscape for the better, making accessing medication simpler and more affordable. Like Amazon.com, Amazon Pharmacy is focused on creating new convenience, value, and selection for customers. Using tools like AI, machine learning, and micro-mobility, Amazon Pharmacy provides consumers with upfront pricing estimates, fast home delivery when they need it, and 24/7 access to pharmacists.

Using Amazon Pharmacy is like having a full-service pharmacy right in your pocket. The online store carries most medications prescribed at the doctor’s office and delivers them free to your front door. The company’s model builds on the concept of mail-order pharmacies, which are generally associated with lower health care costs and improved medication adherence. However, mail-order delivery can take up to two weeks. When you use Amazon Pharmacy, you’ll experience all the benefits of mail order, which typically include lower prices and higher medication adherence, plus even faster delivery.

Continuous innovation

Since its launch in 2020, Amazon Pharmacy has continued to improve the pharmacy experience.

Just last year, the company launched a series of new programs to add value and convenience to customers’ lives. One key initiative is RxPass, which allows Prime members to access unlimited eligible prescription medications for only $5 per month, including free shipping. With over 75 million Americans taking one of the eligible medications, chances are one or more of your medications is included.

Amazon Pharmacy is also automating savings from manufacturer-sponsored coupons. Eligible coupons don’t require customers to download a form, call a manufacturer, or search the fine print. If you’re eligible, coupons will be directly applied at checkout, allowing customers to save time and money. To date, automatic coupons on Amazon Pharmacy have already helped customers save over $15 million.

Amazon is also supporting savings at more than 60,000 participating pharmacies nationwide, including Amazon Pharmacy through the Prime prescription savings benefit. Prime members can receive discounts up to 80% off generic and 40% off brand-name medications at a wide range of locations.

Finally, customers in need of fast treatment can have their medications delivered to their door in hours, not days — via drone in College Station or same-day delivery in Austin, Indianapolis, Los Angeles, Miami, New York, Phoenix, and Seattle. Amazon Pharmacy delivers to every zip code in the US, and can ship directly to your door.

Amazon Pharmacy is pioneering the future of pharmacy with its innovative and customer-centric approach. To learn more about how you can receive affordable and convenient prescription medication, visit Pharmacy.Amazon.com.

World Hypoparathyroidism Day: How an Advocacy Organization is Driving Change to Transform Patients’ Lives

2024-05-31T12:01:01

(BPT) – This World Hypoparathyroidism Awareness Day, a global awareness and education event observed annually on June 1, the HypoPARAthyroidism Association (HPA) is calling for urgent change within the hypoPARAthyroidism (hypoPARA) community. Through educational and advocacy initiatives, we are committed to increasing the understanding of this rare disease, its management and its impact on patients and their families, ultimately improving patient care and outcomes.

What is hypoPARA?

HypoPARA is a rare endocrine disease in which insufficient levels of parathyroid hormone (PTH) lead to lower-than-normal levels of calcium and elevated phosphate levels in the blood. It most commonly results from damage to or removal of the parathyroid glands during neck surgery but may also be inherited and/or associated with other disorders.

A range of serious multi-organ complications are associated with hypoPARA, including kidney disease, cardiovascular disease and decreased cognitive function. As a result of these complications — and the additional risks that can present due to the current standard of care with high doses of oral calcium and active vitamin D — patients living with hypoPARA often experience a significantly decreased quality of life.

Because the current standard of care can only address some symptoms of the disease and not its underlying cause, patients are eagerly awaiting crucial new medications that restore normal levels of PTH. In the United States, hypoPARA remains the only endocrine hormone deficiency for which a hormone replacement therapy is still not broadly available.

Elevating patient voices

Patient surveys continue to reinforce the need for a new treatment paradigm, as seen in our recent Voices of HypoPARA 2.0 survey. Results from our survey found that only 10% of patients were happy with their current treatment option, with many stating they could better manage their condition and associated symptoms with more effective medications.

As the leading patient advocacy organization in the United States, our association was invited to share this data and stories of the severe impacts of the disease with the FDA during our patient-focused drug development session earlier this year. Our goal was to ensure FDA representatives and other key stakeholders understand the ongoing crisis this community faces and the substantial negative impact that the current standard of care can have on patients’ lives.

In a continued effort to raise awareness and change how physicians think about and treat hypoPARA, we will also be participating in various educational panels at this year’s Endocrine Society (ENDO) annual meeting — which coincides with World Hypoparathyroidism Awareness Day.

“We are grateful for the opportunity to represent the patient community to help elevate physician understanding of the significant burdens of living with hypoPARA,” said Patty Keating, Executive Director of the HPA. “Amplifying patients’ voices is crucial for making improvements in diagnosis and care.”

Hope on the horizon

Fortunately, there are new and promising hypoPARA treatment options on the horizon. We’ve seen momentum in the treatment landscape begin to shift and advance internationally, and we hope to see similar progress made in the United States soon.

For those living with hypoPARA, the rollercoaster of gaining and losing promising treatment options over recent years has been devastating. Yet, despite the unique challenges posed by hypoPARA, our community has not lost hope. Patients, caregivers and advocates are standing united in our vision for a future where treatment options are not just effective but also accessible and available to all in need. There’s no reason for hypoPARA patients to suffer any longer.

Together, we hold the promise of better health and a higher quality of life for individuals grappling with hypoPARA. Together, we can Be the Change.

To learn more, visit hypopara.org or facebook.com/hypoPARAassociation/.

Illustration of a woman in an alarm clock and the words

5 Things Previvors Should Know

2024-05-31T05:01:00

(BPT) – 1. “Previvor” means a “survivor of a predisposition to cancer.”

Previvors are people who have an elevated risk, but who have never been diagnosed with cancer.

The term includes people with an inherited mutation that increases their cancer risk, a family history of cancer or some other factor that increases risk. Like cancer survivors, previvors must navigate many medical decisions. They benefit from support and resources to help them stay as healthy as possible.

The nonprofit hereditary cancer organization Facing Our Risk of Cancer Empowered (FORCE) coined the term in 2000 in response to a challenge by a FORCE member who posted, “I need a label!”

2. Genetic testing can help people understand their cancer risk.

Lab tech looking at a vial of blood containing genetic material.

The most well-known genes linked to cancer are BRCA1 and BRCA2. Mutations in these genes increase the risk for breast, fallopian tube, ovarian, pancreatic and prostate cancer. People of any race or ethnicity can have one of these inherited mutations. About one out of every 400 people has a BRCA1 or BRCA2 mutation. These mutations are more prevalent in certain groups. For example, about one in 40 people of Eastern European (Ashkenazi) Jewish ancestry has a mutation.

Dozens of other genes are linked to an increased risk for cancer. Lynch syndrome, although less well known than BRCA1 and BRCA2, is more common. About one out of every 280 people has a Lynch syndrome mutation. Lynch syndrome is caused by a mutation in one of five genes (EPCAM, MLH1, MSH2, MSH6, PMS2). People with Lynch syndrome have an increased risk for colorectal, endometrial, ovarian and other cancers. Inherited mutations in ATM, BRIP1, CDH1, CHEK2, PALB2, RAD51C, RAD51D and other genes are also associated with increased cancer risk.

A single genetic test of blood or saliva can look for mutations in the genes mentioned above and more. Today, testing is quick, easy and often covered by insurance. But testing isn’t always straightforward. It’s important to speak with an expert, known as a genetic counselor, before you are tested.

3. Being aware of your risk could save your life.

Previvors have medical options to manage their cancer risks, including:

  • enhanced screening (getting screened sooner or more often) to find cancer early, at its most treatable stage.
  • medications and lifestyle changes to lower cancer risk.
  • risk-reducing surgery.
  • research studies that are testing new ways to manage risk.

Research shows that people with inherited mutations who take preventive actions live longer. The first step to protecting yourself is knowing your risk for cancer. Guidelines for risk management are different for each gene, so it’s important to see a genetic counselor to understand your options.

4. Up to 90% of previvors do not know they have inherited a mutation that increases their cancer risk.

Most people are unaware of their risk for cancer. People who know about their inherited mutation before a cancer diagnosis can take steps to reduce their risk or increase their chance of catching cancer at an early, more treatable stage. This is why it is important for people to know their family medical history and to share their health information with relatives.

  • FORCE’s brochure, The Genes Between Us, is a comprehensive guide to talking with relatives about inherited cancer risk.
  • Susan G. Komen has great information and a tool for collecting your family history of cancer.
  • The Centers for Disease Control and Prevention (CDC) has a page with tips and stories to help you have a conversation with your relatives about cancer in the family.

5. Previvors don’t have to go it alone.

Support for previvors is just a click away. Facing Our Risk of Cancer Empowered (FORCE) is an advocacy organization with dedicated resources for previvors. The Bring Your Brave campaign from the CDC shares uplifting stories and resources for previvors.

Stroke Prevention: TCAR Procedure Offers New Hope for Carotid Artery Disease Patients

2024-05-30T08:01:00

(BPT) – Did you know carotid artery disease (CAD) is responsible for up to one-third of all strokes? Early detection and treatment of CAD can significantly reduce your risk of having a stroke, and Judy’s story is a testament to this.

After witnessing her grandmother suffer a major stroke, Judy was determined to stay healthy and visited her doctor regularly to get check-ups on her carotid arteries. These vital blood vessels, located on both sides of the neck, deliver oxygen-rich blood to the brain. When they become blocked or narrowed, CAD can develop and lead to a stroke.

With a family history of heart and vascular issues, Judy knew she was at risk. While many people like Judy show no symptoms in the early stages of CAD, patients with one or more of the following risk factors should still pursue screening as early as possible:

  • Diabetes
  • Family history of stroke
  • High cholesterol
  • High blood pressure
  • Older age, especially for men
  • Smoking, or using alcohol or recreational drugs
  • Trauma to the neck

During one of her visits, Judy’s doctor discovered her left carotid artery was blocked. After getting referred to surgery, she underwent carotid endarterectomy, the traditional surgical procedure for CAD. Although the blockage was resolved, she experienced severe pain, facial numbing, and a long recovery period.

Two years later, when her right carotid artery also became blocked, Judy sought a different solution. Dissatisfied with her previous experience, she discovered Transcarotid Artery Revascularization (TCAR), a patient-friendly procedure with several advantages over the traditional surgery:

  • Exceptional stroke prevention, even for high-risk surgical patients
  • Minimally invasive
  • Reduced risk of nerve injury and post-procedure heart attack
  • Shorter procedure time
  • Faster recovery and shorter hospital stays

After undergoing TCAR, Judy stayed one night in the hospital and was able to go home the next morning. She said she felt great after the surgery and quickly returned to her daily activities.

“I look forward to every day,” Judy says. “Without this technology, I would be disabled. I would not have my mental capacity, and that would be a tragedy to me and my family. I have my life because of all the things that people did to make it possible for me to be here. The best thing I can do is just say thank you.”

To learn more about CAD detection and treatment options, please visit Silk Road Medical’s patient education resource: https://protectionfromstroke.com/.

7 tips for summer health and safety

2024-05-29T05:01:00

(BPT) – Summer is just around the corner. After the crazy weather we’ve had nationwide, most everyone is excited to have fun in the sun. As you prepare for lazy days at the beach, traveling with family and backyard barbecues with friends, it’s important to keep your health and safety in mind. Here are some tips to keep you healthy and happy as you and your family enjoy the warmer weather.

1. Be sun safe. Sunscreen is a must! The American Academy of Dermatologists Association recommends using a broad-spectrum sunscreen with SPF 30 or higher, and reapply every two hours, more often if you’re swimming. Make sure you hit places people often miss — your ears, neck and the top of your head. Sun protective clothing is also a great ally, especially if you’re outside hiking, picnicking or watching the kids play softball. A wide-brimmed hat can protect your face and it’s a fashion statement! Good sunglasses round out your ensemble so you’re styling and protected from the sun.

2. Get a summer checkup. If you plan to travel, see your primary care provider before you go to make sure your vaccinations, prescriptions and other healthcare needs are up to date. And don’t forget about your vision! Summer is a great time to schedule an eye exam. Many employee health plans do not include vision, so people can put off this important appointment. But making sure your eyes are in great shape is vital. You can save on your next eye exam with a vision insurance plan, like the one from VSP Individual Vision Plans. Their plans start at as little as $13 per month, and can save you a bundle while you keep your eyes healthy. VSP has the largest doctor network out there and offers 20% savings on additional glasses or prescription sunglasses, including lens enhancements, from a VSP network doctor within 12 months of your last exam. VSP doesn’t have open enrollment periods, so you can start the process anytime, and compare plans to meet your individual needs.

3. Beat the heat. Remember, the sun’s rays are the strongest between 10 a.m. and 4 p.m. If possible, plan outdoor activities before or after this window, or find shady spots for your family to relax and enjoy the day without those harsh rays.

4. Drink plenty of water. Even mild dehydration can make you feel tired, and heat stroke is a dangerous situation. Stay hydrated by carrying water or other non-sugary drinks, and sip often! Watch for signs of heat stroke such as headaches, dizziness, nausea or vomiting. Bottom line, if you notice you’re feeling dragged out and tired in the heat, get inside, drink some water and cool off before it becomes more serious.

5. Plan for bugs. Nobody wants their day outside to be ruined by the irritating creepy-crawlies. Remember to put bug spray or repellent devices in your bag.

6. Travel with a first aid kit. Whether it’s a kids’ soccer game or a family road trip, you should keep a first aid kit in the car. Stock it with antiseptic wipes or spray, bandages of various sizes, gauze and tape, tweezers to remove splinters or ticks, scissors, lotion to soothe sunburn or insect bites, antibiotic ointment like Neosporin, and pain relievers.

7. Practice food safety. Summer is the time for picnics, backyard barbecues and meals on sunny porches. Enjoy eating al fresco, but make sure you think about food safety. In warm temperatures, bacteria can multiply quickly. Remember the two-hour rule: Perishable foods like deli salads and meats should not sit out at room temperature for more than two hours. But, if you’re outside in the heat, that rule goes out the window. Keep hot foods hot, like those burgers you’ve cooked on the grill, and cold foods cold, with ice bowls or freezer packs.

Follow these tips and have a happy, healthy summer! Make the most of the balmy weather with family and friends, find a soothing, shady spot to read a good book, and enjoy!

How a 28-Year-Old Woman Kept Her Sense of Adventure Following a Rare Disease Diagnosis

2024-05-23T11:01:00

(BPT) – In 2018, a vibrant young woman with a passion for theater and education set off on the quest of a lifetime: spending a month walking 500 miles on the Camino de Santiago pilgrimage from France to Spain. Christina K. was also at the beginning of a quest to learn more about a mysterious lump on her collarbone.

Months before her trip, one of Christina’s colleagues insisted she get the lump on her collarbone looked at. While it was bothering her and even made some activities difficult, Christina was hesitant to have it checked because she didn’t want to disrupt her long-planned European trip.

She relented, though, and an initial X-ray and ultrasound led her doctor to conclude it was a lipoma, a common, usually benign, fatty tumor that grows under the skin. With that diagnosis, Christina went on her trip, walking the 500-mile pilgrimage without giving the lipoma more thought.

When she returned, she prepared for surgery to remove the lipoma, taking time off from her rewarding job as a school drama teacher. But instead of hearing that the lump was indeed a lipoma that had been successfully removed, Christina was told by her doctor that he wasn’t sure what type of tumor it was.

Sensing that something was seriously wrong, Christina decided to seek answers from various specialists. She finally received a diagnosis at a university-based medical center. But the answer turned out to be something she’d never heard of: a desmoid tumor. At the time, her surgeon spoke to her about the possibility of removing the tumor. However, he said that it would be a very invasive surgery. In addition to the tumor, he would need to remove her collarbone, surrounding muscle tissue, and part of her sternum. She was informed that the surgery could potentially affect her vocal cords, which were her lifeblood as a singer, actress and educator.

“I went into the specialist’s office as someone who called herself healthy, who went yearly for my checkup, who was proactive in all the ways that I should have been — green smoothies in the morning, lots of exercise through yoga and dance. I was shocked and crushed when I got the diagnosis of a desmoid tumor.”

What is a desmoid tumor?

Desmoid tumors are rare, locally aggressive soft tissue tumors that can form anywhere in the body where there is connective tissue.[1],[2],[3] Also called aggressive fibromatosis or desmoid fibromatosis, these tumors can cause significant pain, loss of physical function and mobility, disfigurement and a diminished quality of life.[1],[2],[4],[5],[6],[7],[8]

Managing desmoid tumors can prove to be challenging.[2],[5],[6] Unpredictable by nature and with a high likelihood of recurrence, desmoid tumors have a significant impact on people’s lives.[6],[9],[10] Their invasive growth patterns exert pressure on nearby connective tissue and, in some instances, vital organs, potentially leading to life-threatening complications.[2],[5],[11]

Alternatives to surgery

Before making a decision about surgery, Christina met with her new oncologist and learned that surgery to remove desmoid tumors can be extremely complicated and often not successful.

“Desmoid tumors have these tendrils, like an octopus,” Christina said. “You need to make sure you get every trace of them, because otherwise they can recur.”

In fact, up to 77% of people with a desmoid tumor can experience recurrence following surgical removal.[12],[13]

With no U.S. Food and Drug Administration (FDA)-approved treatment for desmoid tumors available at the time, Christina’s oncologist recommended several off-label treatments, including chemotherapy to try to shrink the tumor, which had grown to the size of a grapefruit.

The next few years were difficult for Christina, as she experienced severe reactions to the treatments that ranged from swelling and aching joints to nausea and her hair turning white. Unfortunately, none of the medicines slowed the tumor’s growth, much less shrank it. During that time, the COVID-19 pandemic began, forcing Christina into isolation to protect her now immuno-compromised system and making it impossible to continue working as an educator.

A new treatment option

Just as it seemed there might not be any medical treatments left to try, Christina’s doctor told her she could try an investigational treatment that was being studied specifically for desmoid tumors. In 2020, she began taking nirogacestat, now marketed by SpringWorks Therapeutics, Inc. under the brand name OGSIVEO®, and has been on that treatment ever since.

OGSIVEO (nirogacestat) is the first and only FDA-approved treatment for adults with progressing desmoid tumors who require systemic therapy.[14],[15] See Important Safety Information below.

Christina recently marked the six-year anniversary of her desmoid tumor diagnosis. She remembers hoping her tumor would stop growing and stabilize, exactly like her current situation.

Christina is still taking OGSIVEO and says that she has experienced a reduction in pain.

She has become a rare disease advocate through her Girl Meets Cancer Instagram and works as a program coordinator for the Cactus Cancer Society, which helps young adults facing cancer find support, connection and creative outlets.

Just as she confronted the challenge of a 500-mile walk from France to Spain, Christina views all these hurdles as part of her life adventure with a positive attitude that gets her through even the toughest days.

“I don’t like the word ‘journey,'” Christina said. “It’s not. I try to say the word adventure. I’m ready to take this all on as a new adventure.”

Learn more about the FDA-approved treatment option at OGSIVEO.com.

Important Safety Information

What is OGSIVEO?

OGSIVEO is a prescription medication used to treat adults with progressing desmoid tumors who require a medicine by mouth or injection (systemic therapy). It is not known if OGSIVEO is safe and effective in children.

Before taking OGSIVEO tell your healthcare provider about all of your medical conditions, including if you:

  • Have liver problems.
  • Are pregnant or plan to become pregnant. OGSIVEO can harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment.
  • Females who are able to become pregnant:
    • Your healthcare provider will give you a pregnancy test before you start treatment with OGSIVEO.
    • You should use effective birth control during treatment and for 1 week after the last dose. Talk to your healthcare provider about methods that may be right for you.
    • Stop taking OGSIVEO and tell your healthcare provider right away if you become pregnant.
  • Males with female partners who are able to become pregnant should use effective birth control during treatment with OGSIVEO and for 1 week after the last dose.
  • Are breastfeeding or plan to breastfeed. It is not known if OGSIVEO passes into your breast milk. Do not breastfeed during treatment with OGSIVEO and for 1 week after the last dose.

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

You should avoid taking proton pump inhibitors (PPIs) and H2 blockers during treatment with OGSIVEO. Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take OGSIVEO?

  • Take OGSIVEO exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OGSIVEO if you develop side effects.
  • Take OGSIVEO 2 times a day with or without food.
  • Swallow OGSIVEO tablets whole. Do not break, crush, or chew.
  • If you take an antacid medicine, take OGSIVEO 2 hours before or 2 hours after the antacid.
  • If you vomit after taking a dose or miss a dose of OGSIVEO, take your next dose at your regular time. Do not take 2 doses of OGSIVEO to make up the dose.

What should I avoid while taking OGSIVEO?

Avoid eating or drinking grapefruit products, Seville oranges, and starfruit during treatment with OGSIVEO.

What are the possible side effects of OGSIVEO?

OGSIVEO can cause serious side effects, including:

  • Diarrhea. Diarrhea is common with OGSIVEO and may sometimes be severe. Your healthcare provider may tell you to drink more fluids or to take antidiarrheal medicines. Tell your healthcare provider right away if you have diarrhea that lasts longer than a few days and does not get better after taking antidiarrheal medicines.
  • Ovarian problems. Females who are able to become pregnant may have ovarian problems and changes in their menstrual cycle during treatment. OGSIVEO may affect fertility which may affect your ability to have a child. Tell your healthcare provider if you have any changes in your menstrual cycle or hot flashes, night sweats, or vaginal dryness during treatment.
  • Liver problems. OGSIVEO can increase liver enzymes. Your healthcare provider will do blood tests to check your liver function before you start and during treatment with OGSIVEO.
  • New non-melanoma skin cancers. Your healthcare provider will do skin exams before and during treatment with OGSIVEO if you are at risk for skin cancer. Tell your healthcare provider if you have any new or changing skin lesions.
  • Electrolyte (salt) problems. Your healthcare provider will do blood tests to check your phosphate and potassium levels during treatment and may give you medicines to treat low phosphate or low potassium if needed. Tell your healthcare provider if you develop any muscle pain or weakness.

Tell your healthcare provider right away if you have any side effect that bothers you or that does not go away. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OGSIVEO.

The most common side effects of OGSIVEO are:

  • rash
  • nausea
  • tiredness
  • mouth sores
  • headache
  • stomach (abdominal) pain
  • cough
  • hair loss
  • upper respiratory infection
  • shortness of breath

OGSIVEO can affect fertility in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of OGSIVEO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please click here for full Prescribing Information including Patient Information.

[1] Sbaraglia M, Bellan E, Dei Tos AP. The 2020 WHO Classification of Soft Tissue Tumours: news and perspectives. Pathologica. 2021;113(2):70-84. doi:10.32074/1591-951X-213.

[2] Penel N, Chibon F, Salas S. Adult desmoid tumors: biology, management and ongoing trials. Curr Opin Oncol. 2017;29(4):268-274. doi:10.1097/CCO.0000000000000374.

[3] NIH. National Cancer Institute Center for Cancer Research. Desmoid tumor. Accessed October 16, 2023. https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-soft-tissue-tumors/desmoid-tumor.

[4] Cancer.Net. Desmoid tumor: introduction. Accessed October 16, 2023. https://www.cancer.net/cancer-types/desmoid-tumor/introduction.

[5] Constantinidou A, Scurr M, Judson I, Litchman C. Clinical presentation of desmoid tumors. In: Litchman C, ed. Desmoid Tumors. Springer; 2012: Accessed August 2023. https://www.researchgate.net/publication/226455135. doi:10.1007/978-94-007-1685-8_2.

[6] Bektas, M, et al. Desmoid Tumors: A Comprehensive Review. Adv Therapeutics. 2023. doi.org/10.1007/s12325-023-02592-0.

[7] Husson O, Younger E, Dunlop A, et al. Desmoid fibromatosis through the patients’ eyes: time to change the focus and organisation of care? Support Care Cancer. 2019;27(3):965-980. doi:10.1007/s00520-018-4386-8.

[8] Gounder MM, Maddux L, Paty J, Atkinson TM. Prospective development of a patient-reported outcomes instrument for desmoid tumors or aggressive fibromatosis. Cancer. 2020;126(3):531-539. doi:10.1002/cncr.32555.

[9] Skubitz KM. Biology and treatment of aggressive fibromatosis or desmoid tumor. Mayo Clin Proc. 2017;92(6):947-964. doi:10.1016/j.mayocp.2017.02.012.

[10] Easter DW, Halasz NA. Recent trends in the management of desmoid tumors. Summary of 19 cases and review of the literature. Ann Surg. 1989;210(6):765-769. doi:10.1097/00000658-198912000-00012.

[11] Joglekar SB, Rose PS, Sim F, Okuno S, Petersen I. Current perspectives on desmoid tumors: the Mayo Clinic approach. Cancers (Basel). 2011;3(3):3143-3155. doi:10.3390/cancers3033143.

[12] Skubitz KM. Biology and treatment of aggressive fibromatosis or desmoid tumor. Mayo Clin Proc. 2017;92(6):947-964. doi:10.1016/j.mayocp.2017.02.012.

[13] Easter DW, Halasz NA. Recent trends in the management of desmoid tumors. Summary of 19 cases and review of the literature. Ann Surg. 1989;210(6):765-769. doi:10.1097/00000658-198912000-00012.

[14] OGSIVEO. Prescribing Information. SpringWorks Therapeutics, Inc.

[15] Riedel RF, Agulnik M. Evolving strategies for management of desmoid tumor. Cancer. 2022;128(16):3027-3040. doi:10.1002/cncr.34332.

© 2024 SpringWorks Therapeutics, Inc. All rights reserved. OGSIVEO is a registered trademark of SpringWorks Therapeutics, Inc. C_OGS_US_0309 05/24.

The framework for lasting weight loss success

2024-05-22T05:01:00

(BPT) – Everyone is buzzing about prescription GLP-1 medications like Ozempic and Wegovy for weight loss — and rightfully so. GLP-1s (more formally known as glucagon-like peptide 1 agonists) represent an enormous step forward in ending the obesity epidemic in this country. Already, GLP-1s have helped millions of Americans shed stubborn pounds without resorting to unhealthy dieting and unsustainable fitness routines.

But, one aspect of these drugs is often glossed over: GLP-1s are intended to be an “adjunct therapy” — not a standalone treatment — for losing weight and improving your health.

This knowledge has helped the online healthcare giant, LifeMD, outline a unique path for patients using GLP-1s. In connection with its Weight Management Program, the company recently introduced the 6S Framework, its guide to holistic well-being in the era of prescription weight loss drugs. Backed by extensive real-world evidence, this unique ideology is tethered to the notion that true health is about balance — not just the number on the scale. Not surprisingly, the framework has gained traction with those who want to make lasting, sustainable changes to their health.

But what is the 6S Framework and how does it fit into the context of your overall health? It comes down to 6 S’s — six components of a cared-for body and mind. Here’s a rundown:

Sleep. Like an electric vehicle, you need time to recharge your batteries. Far from “down time,” sleep is an active stage of recovery and rejuvenation — a time when some of your mind and body’s most important health-sustaining processes take place.

Sustenance. Sticking with the vehicle analogy, you could think of the foods, drinks and supplements you consume as your fuel. They should provide your body with the nourishment it needs to not only survive, but to thrive. Sustenance is also about avoiding or limiting harmful substances like alcohol and nicotine.

Sweat. Your body is made to move, and it depends on a mixture of resistance, aerobic and flexibility exercises to stay healthy and functional. Think of sweat as the necessary lubricant for all your vehicle’s important parts — parts that include your joints, muscles, tendons and even your brain. Without that lubricant, those parts become weak and rusty. Sweat also balances your systems; it helps you burn off excess energy, and it can also help generate the kind of healthy energy your brain and body need to stay sharp, focused and productive.

Stillness and self-talk. Self-talk is your GPS: it keeps you on the road leading to your goals (and away from detours that lead to trouble). It’s all your questions, reflections, ambitions and doubts — about the past and the future — that together act like dashboard gauges on your lifelong voyage. While a little self-talk is necessary, too much of it can be distracting. It can steer you astray. Self-talk must be balanced with stillness — a state of being that focuses on the here and now.

Stress management. Stress is another form of energy; it can power you forward, but it’s all about how you use it. A little stress can ensure that your needs and wants are adequately satisfied. It can motivate you. But too much stress can lead to excess energy — the kind that causes you to stall out. It’s like revving your engine in the wrong gear.

Social interactions. Think of these as the other cars traveling on the road beside you. These may be your cherished companions — lighting the way forward — or they may be pure congestion that slows your progress. While you rely on others, you also feel the pressure of social connections; they can be a source of external demands, judgments and comparisons. Finding balance in your social life allows you to glean strength and comfort from close friends and loved ones while also limiting the interactions that hold you back.

“At LifeMD, we believe orienting your weight loss journey around the 6S Framework can help you achieve the kind of balance that supports lifelong functional health,” said Anthony Puopolo, President, LifeMD Affiliated P.C.s. “Finding a weight management program that supports your overall health needs, with guidance from licensed providers, in concert with the 6 S’s, can make a meaningful difference in your long-term health and wellness.”

Healthy change is always possible. The impact of GLP-1s has proven that. But while GLP-1s can act as a springboard for improving your overall health, they work best when they are integrated with the 6S Framework, which can help you make smart choices, and “course correct” as needed. To learn more about LifeMD’s unique approach to serving GLP-1 patients, visit us at LifeMD and download our new eBook,The 6S Framework for Sustainable Wellness.”

Navigating Childhood with Hemophilia A: Samuel’s Journey to Treatment

2024-05-20T09:01:00

(BPT) – Article is sponsored and developed by Sanofi. Natalie and Samuel were compensated by Sanofi.

When Natalie and her husband adopted four-year-old Samuel from China, they were excited to learn more about his culture and spend quality time together. However, during the process, Samuel experienced bruising and joint pain that made it difficult for him to walk. This led Natalie to consult with a doctor who recognized Samuel’s symptoms as possible signs of a rare blood disorder. Facing uncertainty about their son’s future, Natalie and her husband brought Samuel to America and prioritized his care and diagnosis.

After seeing a hematologist, Samuel was diagnosed with severe hemophilia A, a rare, lifelong condition that impairs the ability of a person’s blood to clot properly. If left untreated, it can lead to excessive or spontaneous bleeds that can result in joint damage, chronic pain, and potentially impact quality of life.1

While prophylaxis treatment was effective for Samuel, the dosing scheduling was demanding for him, Natalie, and their family. Despite training to conduct Samuel’s infusions at home, they had days when his veins didn’t cooperate. Because of this, they switched to a subcutaneous injection administered under the skin rather than into a vein.

Then one day at school, Samuel fell out of his chair and hit his head. He didn’t show any noticeable symptoms of a bleed at first, but his condition quickly got worse.

“I forgot how to spell my name and couldn’t find my classroom anymore. I had a CT scan, and they found a minor brain bleed,” Samuel said.

“As Samuel grew up (now 12 years old), what we needed in a treatment became clear. He had to be well protected against bleeds, and we knew Samuel preferred infusions,” said Natalie. “And, of course, he wants to stay busy, so minimizing how frequently he has to infuse was a significant consideration, too.”

Embracing the Future by Switching to ALTUVIIIO®

Natalie and Samuel spoke to their doctor about ALTUVIIIO, a once-weekly, first-in-class factor VIII replacement therapy for adults and children with hemophilia A.2 They learned it offers proven bleed protection and helps keep factor levels in the normal to near-normal range (over 40%) for ~3 days in children <12 years old, and in May 2024, the US Food & Drug Administration updated ALTUVIIIO’s label to include positive results from a phase 3 study in children under 12. This pediatric study demonstrated a mean annualized bleeding rate (ABR) of 0.6 with ALTUVIIIO prophylaxis and a safety profile similar to the profile in an earlier ALTUVIIIO study for people with hemophilia A aged 12 years or older. 2

Their doctor helped them understand the benefits of switching to ALTUVIIIO and its most common side effects, including headache and joint pain in adults and adolescents, and fever in children under 12.2 Since switching, Samuel has responded well to treatment, with proven bleed protection and factor activity levels.

Natalie and Samuel worked with their CoRe (Community Resource and Education Manager) and Sanofi Patient Support Services to transition to ALTUVIIIO and secure financial assistance through Sanofi’s Copay Program.

“We felt great about switching to ALTUVIIIO. We are living with a treatment and schedule that works for us and Samuel is getting the most out of being a kid,” Natalie said. “We’re also very pleased with his trough levels, which are around 15% on day seven.” Trough levels measure factor VIII in the blood, which is essential for managing the risk of bleeding.3 “Remember that each person’s hemophilia treatment plan may differ, so you need to work with your HCP to find a treatment plan that is right for you,” Natalie added.

Samuel is now able to spend plenty of time with his family at the beach, play with his friends, and master the Rubik’s Cube. Together, Natalie and Samuel encourage people living with hemophilia, and their care networks, to stay educated and engage with the community.

“If anything about your current treatment is not working for you, from bleed protection to infusion schedules, you should always be confident in advocating for your care,” Natalie emphasized.

Patient experiences on ALTUVIIIO may vary, so talk to your doctor when making treatment decisions. To learn more, visit ALTUVIIIO.com.

INDICATION

ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ALTUVIIIO when you have surgery.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about ALTUVIIIO?

Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.

Who should not use ALTUVIIIO?

You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ALTUVIIIO?

Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.

What are the possible side effects of ALTUVIIIO?

You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

The common side effects of ALTUVIIIO are headache and joint pain.

These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full Prescribing Information.

References

  1. What is Hemophilia? Centers for Disease Control and Prevention (CDC). Last reviewed October 24, 2023. Accessed March 21, 2024. https://www.cdc.gov/ncbddd/hemophilia/facts.html.
  2. ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] prescribing information. Bioverativ Therapeutics, Inc. May 2024
  3. Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26 Suppl 6:1-158

MAT-US-2401906-v1.0-05/2024

© 2024 Sanofi. All rights reserved. ALTUVIIIO and Sanofi are registered trademarks of Sanofi or an affiliate.

Fitness Enthusiast Unexpectedly Finds Cancer through New Screening Test

2024-05-16T06:01:00

(BPT) – Putting Health First

Gym owner and avid fitness enthusiast, Rich, has always prioritized his health. He prides himself on being health conscious, taking steps to maintain his health and keeping up with his annual exams.

After learning about the Galleri® test, a multi-cancer early detection blood test that screens for a “fingerprint” of some of the deadliest cancers before people have symptoms, Rich was interested.

“When I heard the Galleri test screened for cancer, I was very much about that. My wife — a registered nurse — also thought it was a great idea,” said Rich, whose mother passed away of colon cancer.

Rich was able to receive the Galleri test as a benefit from his Nationwide life insurance policy. After speaking with his doctor and obtaining a prescription, Rich moved forward with the test. “I made the appointment, and they did the blood draw. It was as simple as that,” he said.

While doctors can test individually for five specific cancers today, nearly 70% of deaths are caused by cancers without recommended screenings.1,2

The Galleri test is a new proactive tool to screen for cancer. The test looks for DNA shed into the bloodstream by cancers growing in the body. Though there are many types of cancer, these DNA fragments act like a unique “fingerprint” of cancer, which allows the Galleri test to provide direction to a doctor on the cancer’s origin and help guide next steps for diagnosis.3

When Rich received his Galleri test result, he and his wife, Barbara, were surprised to hear it was a Cancer Signal Detected. After a diagnostic evaluation and conversations with his oncologist, Rich was told he had stage three cancer in his head and neck.

“When we found out Rich had cancer, our whole life just turned on a dime. My daughter and I just started crying,” said Barbara.

“But once we learned it was localized and caught early, I felt relief,” Rich recalled. “Because I didn’t have any symptoms, without the Galleri test, we might not have caught my cancer for another six months or a year or longer. If my cancer wasn’t caught when it was, it could have spread and my treatment options could have been more limited.”

Road to Recovery

Rich worked with his oncologist to start treatment and now considers himself on the road to recovery.

“The treatment for cancer can knock you out, and that definitely happened in my case,” said Rich, a self-proclaimed “gym nut.” “It’s going to be a long process to get back to where I was, but I am confident that I’ll conquer it.”

Rich credited Galleri with giving him more control when it came to cancer. Today, he is continuing to focus on his health, including taking other proactive measures to stay healthy, and is thankful for those that brought the Galleri test to him.

Learn More

The Galleri test must be prescribed by a healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate specific antigen (PSA) test and/or cervical cancer screening. It is intended for use in adults with an elevated risk for cancer, such as those aged 50 or older.

The Galleri test does not detect a signal for all cancers, and not all cancers can be detected in the blood. False-positive and false-negative results do occur.

Based on a clinical study of people ages 50 to 79, around 1% are expected to receive a Cancer Signal Detected result, which includes predicted Cancer Signal Origin(s). After diagnostic evaluation, around 40% of people are expected to have a confirmed cancer diagnosis. The overall sensitivity in study participants in head and neck cancer was 85.7% (63.2% for stage I, 82.4% for stage II, 84.2% stage III, 96.0% stage IV).

Learn more at Galleri.com.

Important Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-­positive (a cancer signal detected when cancer is not present) and false-­negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high ­complexity testing. The Galleri test is intended for clinical purposes.

_________________________

[1] US Preventive Services Task Force (USPSTF) recommended cancer screening tests, Grade A,B,C. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results.

[2] American Cancer Society Cancer Facts and Figures 2022. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf. Data on file GA-2021-0065.

[3] Klein EA, Richards D, Cohn A, et al. Clinical Validation of a Targeted Methylation N-Based Multi-Cancer Early Detection Test Using an Independent Validation Set. Ann Oncol. 2021;32(9):1167-1177. Doi: 10.1016/j.annonc.2021.05.806.