Month: March 2023

2023-03-24T08:01:00

(BPT) – Pale skin, shakiness and sweating are just a few symptoms you might associate with hypoglycemia, which is known to be common in people with type 1 diabetes. But type doesn’t matter: People with type 2 diabetes that use insulin or sulfonylureas are at just as much risk.

Because there is a misconception that those living with type 2 diabetes are not prone to experience hypoglycemia, you may not have been provided all the facts about what it is, its symptoms, and how and when to treat it. It’s important to know that:

• 1 in 5 people with type 2 diabetes experience one or more severe hypoglycemia events per year.
  • Hypoglycemia happens when blood glucose level falls below 70mg/dL and/or you begin to feel a range of physical and neurological symptoms, such as dizziness, shakiness, confusion, combative behavior or trouble answering questions. Things can progress quickly to severe hypoglycemia, which is potentially life-threatening.
• Hypoglycemia requires immediate attention.
  • Untreated hypoglycemia can lead to loss of consciousness, seizure, coma, and death. You should work with your doctor to create a plan for managing it just in case it happens. Your plan should be equipped with things like glucose tabs, juice, and glucagon.
• If you take insulin or sulfonylureas, you should have ready-to-use glucagon in your diabetes toolkit for low blood sugar emergencies.
  • Thought leaders in the diabetes space, the American Diabetes Association and the Endocrine Society acknowledge that
    • Anyone taking insulin or sulfonylureas is at high risk for hypoglycemia
    • Anyone taking insulin or sulfonylureas should have a prescription for ready-to-use glucagon
  • You need a safety net if you:
    • tried correcting with food or drink and it’s not working
    • are unable or unwilling to eat or drink
    • feel like passing out
    • have a seizure
• The type of ready-to-use glucagon that you carry is important!
  • Emergency glucagon is typically administered by a third party — who might not be trained in its use — in a moment that may be stressful and cause anxiety. An intuitive, simple-to-administer tool is ideal.

Gvoke HypoPen^® is ready-to-use rescue glucagon that can be used by anyone the moment it is needed, similar to rescue pens used for severe allergic reactions. It’s so simple to administer that in a study designed to simulate an emergency, 99 percent of people used it correctly. It can even be self-administered in certain situations.

If you are living with type 2 diabetes and take insulin or sulfonylureas, talk to your healthcare provider about your risk and adding Gvoke HypoPen^® to your hypoglycemia treatment plan.

INDICATION AND SAFETY SUMMARY
GVOKE is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in adults and kids with diabetes ages 2 years and above. It is not known if GVOKE is safe and effective in children under 2 years of age.

WARNINGS

Do not use GVOKE if:

• you have a tumor in the gland on top of your kidneys (adrenal gland), called a pheochromocytoma.
• you have a tumor in your pancreas called an insulinoma.
• you are allergic to glucagon or any other inactive ingredient in GVOKE.

GVOKE MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

High blood pressure. GVOKE can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. GVOKE can cause low blood sugar in certain people with tumors in their pancreas called insulinomas by making too much insulin in their bodies.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

• rash
• difficulty breathing
• low blood pressure

COMMON SIDE EFFECTS

The most common side effects of GVOKE in adults include:

• nausea
• vomiting
• swelling at the injection site
• headache

The most common side effects of GVOKE in children include:

• nausea
• low blood sugar
• high blood sugar
• vomiting
• abdominal pain
• headache
• pain or redness at the injection site
• itching

These are not all the possible side effects of GVOKE. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

BEFORE USING

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

• have adrenal gland problems
• have a tumor in your pancreas
• have not had food or water for a long time (prolonged fasting or starvation)
• have low blood sugar that does not go away (chronic hypoglycemia)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

HOW TO USE

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

HOW TO STORE

• Keep GVOKE in the foil pouch until you are ready to use it.
• Store GVOKE at temperatures between 68°F and 77°F.
• Do not keep it in the refrigerator or let it freeze.

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

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

Please see the Full Prescribing Information for Gvoke.

2023-03-23T14:01:00

(BPT) – Patient Advocate and Former U.S. Congressman Gregg Harper Shares his Family’s Journey with Fragile X Syndrome and Discusses the Importance of Clinical Trials to Advance Treatment Options

It is said that as parents, we try to teach our children all about life. But ultimately children are the ones that teach their parents what life is all about. For former Congressman Gregg Harper that sentiment has become the driving force behind his political and patient advocacy platforms and his life’s work. For Gregg and his wife, Sidney, parenting their son, Livingston, and daughter, Maggie, has always been their number one priority. So, when they noticed Livingston’s milestone delays as an infant and toddler and then other signs of development delays, they began what would become one of the most challenging yet rewarding experiences of their lives — learning from Livingston along the way.

Over the course of four years, Gregg and Sidney ran from appointment to appointment, consulting countless experts and having Livingston tested and evaluated by pediatricians, neurologists, psychologists and every specialist in between. They were determined to find out what was happening with their son and there was no amount of time or energy that would stop them.

It was ultimately a stroke of luck that led to Livingston’s diagnosis with a rare neurological condition known as Fragile X syndrome. The Harpers’ neighbor was the head of special education for an area school district and had attended a seminar about developmental delays and special education. There she learned about a disorder known as Fragile X. When she returned home, she immediately shared what she learned with Gregg and Sidney thinking it could be the elusive diagnosis they were seeking for Livingston. Ultimately, genetic testing revealed that Livingston did indeed have Fragile X syndrome.

“When someone in your family is faced with a rare disease diagnosis such as Fragile X, and especially when it is your child, at first your world can seem like it’s collapsing,” said Gregg. “But after grieving what you thought ‘might have been,’ it is so important to remind yourself that a diagnosis does not have to define or limit your child’s life. As parents we chose to pour our energy into doing everything we could to ensure that Livingston could live the most fulfilling life possible.”

Fragile X is a genetic disorder that causes symptoms including, but not limited to, developmental delays, intellectual disabilities, learning and behavioral issues, physical abnormalities and anxiety. It is estimated that Fragile X affects 1 in 8,000–11,000 females and 1 in 4,000–7,000 males worldwide.¹

During his younger years, Livingston tried many different medications based on what was available at the time. But unfortunately, their side effects created frustrations for Livingston and his parents. Over the years, he also received occupational therapy and speech therapy. While these interventions helped, Livingston continued to experience sensory overload issues and was prone to self-stimulatory behavior such as flapping his arms and hands when he was overstimulated.

“When Livingston was diagnosed and as he grew, there weren’t many treatment options available and we were committed to trying everything we could while also ensuring our child was still able to be who he was born to be,” said Gregg. “While Livingston never had the opportunity to participate in clinical trials studying investigational treatment options, we strongly encourage individuals to support research of investigational new therapies by participating in clinical trials.”

For Gregg, taking control started in early 2009, when he issued a public service announcement, as part of his political advocacy platform, declaring his commitment to ensuring increased awareness and funding to help families who are blessed with a child with Fragile X. Since then, he has worked with higher education institutions like Mississippi State University (MSU) to create inclusive programs within the higher education system that guide students with disabilities through a college career. Livingston benefitted from his father’s commitment and graduated from Mississippi State University in 2013 from the ACCESS Program. Then, in 2010, Gregg’s work with George Mason University (GMU) expanded to include the launch of an internship program with MASON LIFE students and six U.S. House of Representative offices in Washington, D.C.

“After Livingston’s diagnosis and watching him face the challenges of his disorder, my platform in Congress became an opportunity to help educate others about Fragile X and other intellectual disabilities,” said Gregg. “My son’s perseverance and our family’s commitment to providing him with every opportunity possible inspired me to advocate for the thousands of children and families struggling with the same or similar experiences.”

Over eight years, the special needs students in the Mason Life program at GMU and within Congress grew to work as interns across more than 300 congressional offices from both the U.S. House of Representatives and Senate. In December 2018, Gregg and Livingston were honored at a reception along with other student interns and learned the program was being renamed to “The Gregg and Livingston Harper Congressional Internship Program for Individuals with Intellectual Disabilities.”

Today, Livingston is 33 years old and doing well, despite continued social avoidance behaviors which he manages to the best of his ability. He has a job and regularly spends time with lifelong friends.

Gregg notes, “If my wife and I could give one piece of advice to parents of children with Fragile X or any intellectual disability it would be to never stop fighting for your child’s right to live a life without limits. After the devastation and disappointment, look for the opportunities to learn from your child’s journey and the community it can bring your child and family into.”

He concludes, “Livingston is an example of a child who has never given up despite his diagnosis and associated challenges. We’ve learned so much from him!”

To learn more about Fragile X syndrome and an ongoing clinical trial of an investigational treatment, visit FragileXHelp.com for more information.

Content sponsored and provided by Zynerba Pharmaceuticals, Inc. Gregg Harper has partnered with Zynerba to increase awareness of Fragile X syndrome and highlight the vital role of clinical trials in discovering and studying new investigational treatments for rare diseases.

1. https://fragilex.org/understanding-fragile-x/fragile-x-101/

2023-03-23T13:01:00

(BPT) – We often talk about breast cancer as if it is one disease. “Yeah, she had breast cancer,” or “she had a lump removed.” Even, “she has breast cancer. She’s going through chemo.”

But all breast cancers may not be the same. And chances are good that unless you or someone you are close to has been impacted directly, you may not know that.

Most breast cancers are defined by the presence of certain cancer cell receptors – specifically, hormone receptors called estrogen and progesterone receptors and a protein called human epidermal growth factor 2 (HER2). Knowing which receptors are present helps a doctor choose a treatment that a cancer type is most likely to respond to.

About 10-15% of all breast cancers, however, have little to no presence of any of these three receptors. In fact, they’re so named: “triple-negative” (TNBC), for the absence of all three.

Triple-negative breast cancers tend to spread faster than other breast cancers, and because they don’t have the hormone receptors or HER2 protein, there are fewer medicines that work against them. This makes TNBC more aggressive than other invasive breast cancers.

“It’s triple-negative breast cancer” is often a much different diagnosis than “it’s breast cancer.”

Younger Women and People of Color Are Most Likely to Receive a TNBC Diagnosis

TNBC can take an especially hard toll. It affects younger women, before many have even started thinking seriously about mammograms or screenings. It is more likely to be diagnosed in women under 40 than most other types of breast cancer, and it is more common in Black and Hispanic women. To add to this, because it’s aggressive, it can become very serious very quickly. Once it spreads, only about 12% of women with metastatic disease survive 5 years.

Treatment Options For TNBC Are Expanding

For women who are facing an advanced TNBC diagnosis, it’s important to talk to the doctor about treatment options. Most patients with advanced or metastatic disease (TNBC that has spread) will receive chemotherapy, but many will progress at some point – even if the chemotherapy works initially. Until recently, there have been no other options after chemotherapy stops working. That is changing.

Trodelvy^® (sacituzumab govitecan-hziy) is a different kind of medicine, called an antibody-drug conjugate (ADC), that is approved for adults with second-line and later metastatic TNBC (after two or more prior treatments, including one for metastatic disease). Trodelvy is indicated for TNBC (negative for estrogen and progesterone hormone receptors and HER2) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease. That means when chemotherapy stops working, people with metastatic TNBC have another option.

Please click to see Important Facts about Trodelvy, including Important Warning for low white blood cell count and diarrhea.

If you or someone you know has metastatic TNBC, speak with a doctor about potential therapies, including Trodelvy. For more information, please visit https://www.trodelvy.com/.

IMPORTANT SAFETY INFORMATION

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

• Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
• Severe diarrhea. Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check to see if it may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
• Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.

Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.

Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).

Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

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

• have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
• have liver problems.
• are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
• Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
• Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
• are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.

The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.

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

WHAT IS TRODELVY?

TRODELVY^® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with triple-negative breast cancer (negative for estrogen and progesterone hormone receptors and HER2) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

Please click to see Important Facts about Trodelvy, including Important Warning.

A message from Gilead Sciences, Inc.

TRODELVY and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

© 2023 Gilead Sciences, Inc. All rights reserved. US-TROC-0263 02/23

2023-03-22T11:01:00

(BPT) – “It’s the stuff fans can’t see that’s hard to deal with.”

Pushing through challenges is something professional soccer player, coach, and avid runner Rosie White* knows well. In a career that has spanned over a decade, she’s competed at the university-level to the world’s biggest athletic stage. But at a major international tournament, Rosie faced her biggest challenge yet: ulcerative colitis.

Ulcerative colitis (UC) is a disease of the large intestine and rectum in which the lining of the colon becomes inflamed and can develop sores, which are also called ulcers. UC is a chronic, lifelong condition that can be diagnosed at any age; however, many are diagnosed between the ages of 15 and 30. It is estimated that about 600,000 to 900,000 people in the United States have been diagnosed with UC.

For White, her challenges with UC began while playing at an international game with the New Zealand National Team. White started to feel unwell, experiencing abnormal bowel function, pain, and blood in her stool, and decided to step off the field because she didn’t understand what was happening with her body.

White sought the opinion of a gastroenterologist in the U.S., who suspected she had UC and confirmed her diagnosis after a series of tests and was put on an initial treatment.

For White, her diagnosis was difficult to process: “It was a relief to know that there was something real happening and there was a way to help manage symptoms, but it also felt like a burden to be facing a lifelong disease.”

The symptoms of UC can vary from person to person, but often includes urgent and frequent bowel movements, bloody stool, abdominal cramps and pain, and diarrhea. While patients can find it difficult or embarrassing to discuss these symptoms, it is important to talk to a healthcare provider and be as open as possible.

Creating the Playbook

For patients with chronic conditions, such as UC, managing their disease and finding the right treatment plan for them may take years. For White, managing her UC while playing soccer professionally brought its own set of obstacles.

“I tend to internalize stress and I don’t always recognize emotional stress until it affects me physically,” said White.

She experienced multiple flares over several years, many of which coincided with important tournaments and competitions. The constant travel and not having control over her schedule or when or what she ate impacted her ability to manage her condition.

“Preparing for tournaments was an especially stressful time as we were supposed to be at our very best, but I was, in fact, at my worst,” explained White. “As an athlete, it’s your job to be in control of your body and your performance. Playing soccer on the world stage, I experienced a lot of worry over having a flare while I needed to perform at a major soccer tournament.”

Over several years, White was prescribed a variety of treatments for her UC, but whenever she started to feel better, she would stop taking her treatment as prescribed, thinking she would no longer need it. But then, her symptoms continued to come back.

White was determined to take back control of her condition and find an option that helped her symptoms. After moving to Seattle, her new physician explained her options and helped her find a treatment that worked best for her new diagnosis of moderate to severe UC and her lifestyle.

Today, progress in research has led to the development of additional treatment choices for UC, including those outside of biologics and injectables, like the once-daily pill Zeposia.

Zeposia™ (ozanimod) is the first and only FDA-approved treatment of its kind for adults with moderate to severely active UC. As an S1P receptor modulator, Zeposia targets a specific part of immune cells called an S1P receptor. The S1P receptor plays a role in the UC inflammation process. The exact way Zeposia works is not known.

Zeposia has been shown to help patients achieve and maintain remission, while reducing symptoms such as rectal bleeding and stool frequency in as early as two weeks.

For White, Zeposia offered a treatment option that fit with her schedule: “It made sense for the way I wanted to live my life and the fact that it is a pill makes it a lot less daunting to me.”

White’s doctor helped her understand the serious side effects that are possible with Zeposia, including an increased risk of serious infections, PML—a rare brain infection, slow heart rate, liver problems, increased blood pressure, breathing problems, a vision problem called macular edema, and swelling and narrowing of blood vessels in the brain. See additional Important Safety Information below.

Settling The Score

It is important for patients experiencing UC symptoms to seek medical attention and advocate for themselves to find the right diagnosis and treatment plan that works for them. For White, the turning point in her UC journey was being able to communicate with her physician who helped find her a treatment plan that worked for her lifestyle.

With a treatment plan that works well for her, White is able to continue doing the things she loves, such as coaching soccer and advocating the importance of physical activities for children.

Zeposia may not work for everyone. Individual results may vary. Patients should speak with their health care provider to learn more.

Her advice for others? Always advocate for yourself, have an open conversation with your healthcare professional, and most importantly, never give up.

*Rosie White is an actual Zeposia patient who was compensated by Bristol Myers Squibb for her time

Source: Bristol Myers Squibb

INDICATION

ZEPOSIA^® (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults.

It is not known if ZEPOSIA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take ZEPOSIA if you:

• have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months

• have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker

• have untreated, severe breathing problems during your sleep (sleep apnea)

• take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid)

Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions.

ZEPOSIA may cause serious side effects, including:

• Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of your white blood cells before you start taking ZEPOSIA.

Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA:

• fever

• feeling very tired

• flu-like symptoms

• cough

• painful and frequent urination (signs of a urinary tract infection)

• rash

• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection.

•Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance.

• Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA.

Call your healthcare provider if you experience the following symptoms of slow heart rate:

• dizziness

• lightheadedness

• feeling like your heart is beating slowly or skipping beats

• shortness of breath

• confusion

• chest pain

• tiredness

Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose.

Continue reading for additional possible serious side effects of ZEPOSIA.

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

• have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system

• received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZEPOSIA may cause vaccines to be less effective

• before you start ZEPOSIA, your healthcare provider may give you a chickenpox (Varicella Zoster Virus) vaccine if you have not had one before

• have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA

• have a slow heart rate

• have an irregular or abnormal heartbeat (arrhythmia)

• have a history of stroke

• have or have had heart problems, including a heart attack or chest pain

• have high blood pressure

• have liver problems

• have breathing problems, including during your sleep

• have eye problems, especially an inflammation of the eye called uveitis

• have diabetes

• are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA.

• are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA

Tell your healthcare provider about all the medicines you take or have recently taken, including

prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

• medicines that affect your immune system, such as alemtuzumab

• medicines to control your heart rhythm (antiarrhythmics), or heartbeat

• CYP2C8 inducers such as rifampin

• CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood)

• opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease

• medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)

You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.

ZEPOSIA can cause serious side effects, including:

• liver problems. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:

• unexplained nausea

• vomiting

• stomach area (abdominal) pain

• tiredness

• loss of appetite

• yellowing of the whites of your eyes or skin

• dark colored urine

• increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine.

• breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.

• a problem with your vision called macular edema. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Your healthcare provider should test your vision before you start taking ZEPOSIA if you are at higher risk for macular edema or any time you notice vision changes during treatment with ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:

• blurriness or shadows in the center of your vision

• sensitivity to light

• a blind spot in the center of your vision

• unusually colored vision

• swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms of PRES usually get better when you stop taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:

• sudden severe headache

• sudden confusion

• sudden loss of vision or other changes in your vision

• seizure

The most common side effects of ZEPOSIA can include:

• upper respiratory tract infections

• elevated liver enzymes

• low blood pressure when you stand up (orthostatic hypotension)

• painful and frequent urination (signs of urinary tract infection)

• back pain

• high blood pressure

• headache

These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

To learn more, visit Zeposia.com.

2084-US-2201520 03/23

2023-03-21T17:29:00

(BPT) – On a Friday night in 1999, Al saw a TV commercial about a new cancer treatment that was enrolling patients in a clinical trial — a novel, targeted therapy that scientists were investigating for the treatment of chronic myeloid leukemia (CML), a cancer that develops in the blood-forming cells of the bone marrow.

Two years prior, Al had been diagnosed with CML. At that time, his treatment options were limited. Most people with this diagnosis faced a five-year survival rate below 40%.

Al called his doctor the following Monday to find out if the new treatment — a tyrosine kinase inhibitor (TKI) — might be right for him. He was accepted into the trial a few months later — an impactful step that is indicative of the future of Al’s treatment journey, and the bravery he continually displayed through every high and low.

A Long and Winding Road

The clinical trial Al enrolled in led to the FDA approval of the first TKI for the treatment of CML, and the first-ever targeted therapy acting on specific cancer cells while causing less damage to normal cells.

With the introduction of TKIs, the five-year survival rate for patients diagnosed with CML improved, increasing to over 70%, bringing the lifespan of a patient with CML closer to the lifespan of a person without cancer.

However, despite the significant positive impact on the treatment of CML, it is not uncommon for some patients to not respond to certain TKIs, or struggle with side effects, or find that their response or tolerability to a specific TKI changes over time.

After the clinical trial was complete, Al decided to stay on the treatment. However, while the treatment was easy to tolerate — giving him few side effects — Al’s doctors told him that his CML was not responding as well as it should have been and there was a risk that his CML would progress and become more severe.

Al participated in more clinical trials before finding a treatment that was right for him in his fourth trial. This treatment was for a different type of TKI known as Scemblix^® (asciminib) tablets. Scemblix is approved by the FDA for adults with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) who have previously been treated with two or more TKIs¹. More information about Scemblix can be found at us.scemblix.com.

Scemblix targets CML differently than other TKIs. Because cancer can mutate when it gets accustomed to how a treatment works, approaching it in a new way can outsmart the mutations. Scemblix may help patients overcome the resistance and side effects patients with CML may experience with other TKIs.

In a clinical trial, Scemblix showed how well it works to counteract cancer compared with Bosulif^® (bosutinib), another TKI, in patients who had previously tried two or more TKIs¹. Nearly twice as many patients on Scemblix achieved major molecular response, or MMR (25% for Scemblix [40 of 157] vs. 13% for Bosulif [10 of 75]) at 24 weeks, which is an important treatment milestone in CML, meaning that there is a low amount of the BCR::ABL in blood cells¹.

This efficacy trend continued at 96 weeks, almost two years after the trial started, when more patients on Scemblix achieved MMR compared to those on Bosulif (38% [59 of 157] vs. 16% [12 of 76])¹.

Additionally, in this trial [one study for 3L CML], three times fewer patients treated with Scemblix needed to stop treatment due to side effects compared to those taking Bosulif (8% for Scemblix vs. 26% for Bosulif) at the Week 96 analysis¹. The most common adverse reactions in patients who received Scemblix in this trial were upper respiratory tract infections, musculoskeletal pain, headache, and fatigue¹.

Al’s journey to the right treatment was made possible not only by his bravery in trying new treatment options, but also by good communication with his doctor. While Scemblix may not be right for everybody, it helped Al achieve his milestones.

Want to learn more about Al’s story and Scemblix? Visit us.scemblix.com.

APPROVED USES for SCEMBLIX^® (asciminib) Tablets

SCEMBLIX is a prescription medicine used to treat adults with:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
• Ph+ CML in CP with the T315I mutation

It is not known if SCEMBLIX is safe and effective in children.

IMPORTANT SAFETY INFORMATION for SCEMBLIX^® (asciminib) Tablets

Before taking SCEMBLIX, tell your doctor about all your medical conditions, including if you:

• have a history of inflammation of your pancreas (pancreatitis)
• have a history of heart problems or blood clots in your arteries and veins (types of blood vessels)
• are pregnant or plan to become pregnant. SCEMBLIX can harm your unborn baby
  • Your doctor will do a pregnancy test before you start treatment with SCEMBLIX
  • Females who are able to become pregnant should use effective birth control during treatment and for 1 week after your last dose of SCEMBLIX. Talk to your doctor about birth control methods that may be right for you
  • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with SCEMBLIX
• are breastfeeding or plan to breastfeed. It is not known if SCEMBLIX passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of SCEMBLIX

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SCEMBLIX and other medicines may affect each other and cause side effects.

SCEMBLIX may cause serious side effects, including:

• Low blood cell counts: SCEMBLIX may cause low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Your doctor will do blood tests to check your blood cell counts every 2 weeks for the first 3 months of treatment and then monthly or as needed during treatment with SCEMBLIX. Tell your doctor right away if you have unexpected bleeding or easy bruising, blood in your urine or stools, fever, or any signs of an infection
• Pancreas problems: SCEMBLIX may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your doctor may do blood tests monthly or as needed during treatment with SCEMBLIX to check for problems with your pancreas. Tell your doctor right away if you have sudden stomach-area pain or discomfort, nausea, or vomiting
• High blood pressure: Your doctor may check your blood pressure and treat any high blood pressure during treatment with SCEMBLIX as needed. Tell your doctor if you develop elevated blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath
• Allergic reaction: Stop taking SCEMBLIX and get medical help right away if you get any signs or symptoms of an allergic reaction, including:
  • trouble breathing or swallowing
  • swelling of the face, lips, or tongue
  • skin rash or flushing of your skin
  • feeling dizzy or faint
  • fever
  • fast heartbeat
• Heart and blood vessel (cardiovascular) problems: SCEMBLIX may cause heart and blood vessel problems, including heart attack, stroke, blood clots, blockage of your arteries, heart failure, and abnormal heartbeat, which can be serious and may sometimes lead to death. These heart and blood vessel problems can happen in people with risk factors or a history of these problems, and/or previously treated with other TKI medicines. Your doctor may monitor you for heart and blood vessel problems and treat you as needed during treatment with SCEMBLIX. Tell your doctor or get medical help right away if you get:
  • shortness of breath
  • chest pain or pressure
  • a feeling like your heart is beating too fast or you feel abnormal heartbeats
  • swelling in your ankles or feet
  • dizziness
  • weight gain
  • numbness or weakness on one side of your body
  • decreased vision or loss of vision
  • trouble talking
  • pain in your arms, legs, back, neck, or jaw
  • headache
  • severe stomach-area pain

The most common side effects of SCEMBLIX include:

• nose, throat, or sinus (upper respiratory tract) infections
• muscle, bone, or joint pain
• headache
• tiredness
• nausea
• rash
• diarrhea
• decreased blood platelet counts, white blood cell counts, and red blood cell counts
• increased blood fat (triglycerides) levels
• increased blood creatine kinase levels
• increased blood liver enzyme levels
• increased blood pancreas enzyme (amylase and lipase) levels
• increased blood uric acid levels

Your doctor may change your dose, temporarily stop, or permanently stop treatment with SCEMBLIX if you have certain side effects.

SCEMBLIX may cause fertility problems in females. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

These are not all the possible side effects of SCEMBLIX. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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.

Please see accompanying full Prescribing Information, including Patient Information.

Reference

1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.

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