Month: December 2024

2024-12-17T08:01:00

(BPT) – By Brandpoint

Michael was only four years old when he was diagnosed with hemophilia B, a genetic bleeding disorder that affects the body’s ability to generate factor IX, a protein crucial for blood clotting. “It was scary in the beginning,” Michael said. “Kids that age like to copy stuff on TV, and I wanted to play sports or be like Spider-Man. As a preschooler, I really had no idea how to comprehend my diagnosis. And then to learn that I’d have to stick myself with needles multiple times a month made me anxious.”

Hemophilia B causes prolonged bleeding and increases the risk for internal bleeding in the muscles and joints, which can be life threatening if untreated. Missing or insufficient amounts of factor IX can be replaced by medicine to help the body clot properly. The standard treatment for people with hemophilia B involves lifelong, preventative or on-demand factor replacement therapy, which may be infused multiple times a month intravenously (into a person’s veins). However, recent advancements in gene therapy offer new hope.

HEMGENIX^® (etranacogene dezaparvovec-drlb) provides a one-time infusion that can elevate factor IX levels for years, offering greater bleed protection and significantly reducing the need for regular infusions. Michael, who received HEMGENIX, shares his journey with this innovative treatment.

This is Michael’s personal experience. Every patient experience is different. For more information, visit https://www.hemgenix.com.

Q: Before you tried gene therapy, you were on prophylaxis treatment. What was that like?

A: I had to learn to self-infuse prophylaxis from a very early age. Otherwise, I’d have to go to the hospital for treatment anytime I got injured — even from something small like jamming my finger playing basketball.

Once I was consistent with my infusions, I didn’t need to go to the hospital as often, but I still sometimes experienced breakthrough bleeds. I tried not to let hemophilia B hold me back, and I participated in equestrian classes, swimming, basketball and golf, though I had to prepare for activities more than the average kid. I knew if I was going to play basketball, I may get injured, so I would self-infuse before I left the house. I also had to have my medicine with me in case I got hurt or I had to go to the hospital. It was just something I had to deal with.

Q: How did you learn about gene therapy? What motivated you to move forward with treatment?

A: My condition meant I was in and out of the doctor’s office a lot, so I became pretty close to my care team. While I was in college a few years ago, they introduced me to a new treatment option called HEMGENIX.

Around the same time, I had suffered a pretty serious injury, tearing one of my pectoral muscles at the gym. I had to undergo surgery, which was scary because my hemophilia puts me at a higher risk of bleeding during the surgery and recovery. I had to self-infuse more frequently during this time and relied more on my family than ever as an adult. I thought, if there’s a chance to stop sticking myself and help me become more independent, I’ll take it. After discussing my options with my doctor, we decided that HEMGENIX would be a good option for me.

Q: What was receiving gene therapy like?

A: After going through the pre-screening tests and getting approval from my insurance company, I received an infusion date. HEMGENIX was quite new at the time, and there wasn’t a treatment center near my home, so my grandmother and I drove from Louisiana to Mississippi for my infusion. I remember being very excited the entire drive. After having to self-infuse prophylaxis multiple times a month for most of my life, I was hopeful to receive a one-time treatment that could potentially reduce or eliminate my regular infusions for years.

The infusion process took a little over an hour, followed by a few hours of monitoring for infusion-related reactions before I could go home. For me, it was a simple process, and I used the time to get homework and studying done while at the center. Even though I knew what to expect, I still couldn’t believe how easy it was for me.

Q: What’s life like now after your infusion?

A: After receiving HEMGENIX, there were several follow-up appointments I had to do with my doctor, including liver and blood enzyme tests to monitor for any elevations. I also had to watch for any side effects such as headaches, flu-like symptoms, fatigue, nausea, or feeling unwell. Today, my life no longer revolves around my infusion schedule. I haven’t experienced a breakthrough bleed since receiving HEMGENIX and I no longer need regular infusions. I’ve noticed that I feel more confident and less stressed because I know my factor IX levels are steady. I’m not always thinking about if and when I need to infuse. I exercise and play basketball now without having to self-infuse beforehand or afterwards.

I’m currently focused on pursuing my MBA, which I am excited to complete soon. From there, I’m going to pursue a career in business, and I look forward to many of life’s new adventures without the stress of constant infusions.

Q: What message would you like to share with the broader community about living with hemophilia B?

A: I’ve been managing hemophilia B since elementary school and while I tried not to let it stop me from doing the things I wanted, it definitely can be physically and mentally challenging at times. It was always a nagging thought in the back of my head — something I had to constantly consider and be aware of. Having a support system in place is very important.

When my doctor introduced me to HEMGENIX, I was thrilled by the potential benefits but also nervous. Learning all I could about the benefits and risks ultimately helped me make the best decision for myself. However, everyone is different, and needs can change over time, so it’s great that we have so many choices available today. I encourage everyone living with hemophilia B to regularly discuss their treatment options with their doctor to find what works best for them.

What is HEMGENIX?

HEMGENIX^®, etranacogene dezaparvovec-drlb, is a one-time gene therapy for the treatment of adults with hemophilia B who:

• Currently use Factor IX prophylaxis therapy, or
• Have current or historical life-threatening bleeding, or
• Have repeated, serious spontaneous bleeding episodes.

HEMGENIX is administered as a single intravenous infusion and can be administered only once.

What medical testing can I expect to be given before and after administration of HEMGENIX?

To determine your eligibility to receive HEMGENIX, you will be tested for Factor IX inhibitors. If this test result is positive, a retest will be performed 2 weeks later. If both tests are positive for Factor IX inhibitors, your doctor will not administer HEMGENIX to you. If, after administration of HEMGENIX, increased Factor IX activity is not achieved, or bleeding is not controlled, a post-dose test for Factor IX inhibitors will be performed.

HEMGENIX may lead to elevations of liver enzymes in the blood; therefore, ultrasound and other testing will be performed to check on liver health before HEMGENIX can be administered. Following administration of HEMGENIX, your doctor will monitor your liver enzyme levels weekly for at least 3 months. If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.

What were the most common side effects of HEMGENIX in clinical trials?

In clinical trials for HEMGENIX, the most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell. These are not the only side effects possible. Tell your healthcare provider about any side effect you may experience.

What should I watch for during infusion with HEMGENIX?

Your doctor will monitor you for infusion-related reactions during administration of HEMGENIX, as well as for at least 3 hours after the infusion is complete. Symptoms may include chest tightness, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and elevated blood pressure. If an infusion-related reaction occurs, the doctor may slow or stop the HEMGENIX infusion, resuming at a lower infusion rate once symptoms resolve.

What should I avoid after receiving HEMGENIX?

Small amounts of HEMGENIX may be present in your blood, semen, and other excreted/secreted materials, and it is not known how long this continues. You should not donate blood, organs, tissues, or cells for transplantation after receiving HEMGENIX.

Please see full prescribing information for HEMGENIX.

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

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.

HEMGENIX is manufactured by uniQure Inc. and distributed by CSL Behring LLC.

HEMGENIX^® is a registered trademark of CSL Behring LLC.

©2024 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA

USA-HGX-0907-NOV24

2024-12-17T09:01:00

(BPT) – In 2024, more than 100,000 people will be diagnosed with melanoma, a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells called melanocytes located in the skin. When melanoma spreads beyond the surface of the skin to other organs (also known as advancing), it can become deadly, which is why it is important to understand the available treatment options if you or a loved one are facing a melanoma diagnosis.

Melanoma is considered the most serious form of skin cancer because it is more likely to spread to other areas of the body. When someone is diagnosed with melanoma, doctors must determine the stage of the cancer, meaning how much the cancer has spread in the body. As melanoma becomes more advanced, meaning it has spread to other organs, it becomes more challenging to treat and survival rates decline. Of patients newly diagnosed with stage I and II melanomas, stage II makes up approximately 16.5%, and approximately half of these are IIB and IIC.

Fortunately, many melanoma patients have treatment options. Surgery, also known as resection, is what most physicians recommend to treat stage IIB or IIC melanoma. However, about one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected stage IIC melanoma experience recurrence (the cancer coming back) within five years after diagnosis. Due to innovations in the melanoma treatment landscape, immunotherapy can be used to treat eligible melanoma patients after surgery. Immunotherapies are designed to use a patient’s own immune system to help prevent the cancer from coming back.

Adjuvant therapy is an additional cancer treatment given after the primary treatment (or surgery for early-stage diagnosis) to help prevent the cancer from coming back. Thanks to treatment innovations, there are adjuvant immunotherapy options for eligible patients that are designed to use a person’s own immune system to help fight their cancer.

In 2023, Opdivo^® (nivolumab) was approved by the U.S. Food and Drug Administration as a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years and older with stage IIB, stage IIC, stage III or stage IV melanoma to help prevent melanoma from coming back after it has been completely removed by surgery. This approval provides a treatment option for these melanoma patients that may help prevent their cancer from returning.

Opdivo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Serious side effects may include lung problems, intestinal problems, liver problems, hormone gland problems, kidney problems, and skin problems. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms. Please see additional Important Safety Information below.

“Opdivo is a PD-1 inhibitor (a type of immunotherapy) that is indicated as an adjuvant treatment for eligible patients with stages IIB, IIC, III, as well as stage IV completely resected melanoma,” said Hussein A. Tawbi, MD, PhD, Melanoma Medical Oncologist, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.* “This therapy may help prevent cancer from coming back, providing a treatment option and hope for these patients.”

With the cases of melanoma rising worldwide, it’s important to know and understand the different treatment options available to treat early-stage melanoma that can be removed by surgery. “If you or a loved one has been diagnosed with melanoma, you should speak with your healthcare team about your treatment options based on your specific diagnosis,” said Dr. Tawbi. “Adjuvant treatment options, such as immunotherapy, may be an option.”

If you or a loved one is diagnosed with early-stage melanoma, be sure to ask the healthcare team if Opdivo could be a treatment option after surgery. To learn more about Opdivo, visit Opdivo.com.

*Dr. Tawbi has previously served as a clinical trial investigator and scientific advisor to Bristol Myers Squibb.

INDICATION:

OPDIVO^® (nivolumab) is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years and older with Stage IIB, Stage IIC, Stage III or Stage IV melanoma to help prevent melanoma from coming back after it has been completely removed by surgery.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.

Important Safety Information for OPDIVO^® (nivolumab)

What is the most important information I should know about OPDIVO?

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

• Lung problems: cough; shortness of breath; chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
• Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heart beat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
• Skin problems: rash; itching; skin blistering or peeling; swollen lymph nodes; painful sores or ulcers in the mouth or nose, throat, or genital area; fever or flu-like symptoms

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• Chest pain; irregular heart beat; shortness of breath; swelling of ankles
• Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs
• Double vision; blurry vision; sensitivity to light; eye pain; changes in eye sight
• Persistent or severe muscle pain or weakness; muscle cramps
• Low red blood cells; bruising

Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.

Possible side effects of OPDIVO

OPDIVO can cause serious side effects, including:

• See “What is the most important information I should know about OPDIVO?”
• Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain
• Complications of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO. Your healthcare provider will monitor you for these complications.

The most common side effects of OPDIVO, when used alone, include: feeling tired; rash; pain in muscles, bones, and joints; itching; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; stomach-area (abdominal) pain; vomiting; and urinary tract infection.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

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

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO and for 5 months after the last dose of OPDIVO.

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start receiving OPDIVO.

• You should use an effective method of birth control during your treatment and for 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO.

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

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.

©2024 Bristol-Myers Squibb Company. OPDIVO^® is a registered trademark of Bristol-Myers Squibb Company.

1506-US-2400473 12/24

2024-12-17T09:01:00

(BPT) – When most people think of advanced melanoma treatment, their first thought likely includes chemotherapy, radiation and surgery. Immuno-oncology (IO), also known as immunotherapy, has changed how advanced melanoma can be treated.

Unlike chemotherapy, radiation and surgery, which directly target the tumor, IO uses medication that is designed to leverage the body’s own immune system to help recognize and target tumor cells. IO has the potential to help stop tumor growth or shrink tumors, and it can come in two forms: monotherapy (one immunotherapy) or dual IO (two immunotherapies working together).

Finding an Appropriate Treatment

The first dual IO medication for the first-line treatment of metastatic melanoma (the deadliest form of skin cancer) was approved nearly 10 years ago. Since then, dual IO has become a critical pillar in advanced melanoma treatment. One treatment option in advanced melanoma for adults and children 12 years of age or older is Opdualag™ (nivolumab and relatlimab-rmbw), which is designed to work by connecting to tired T cells and activating them so they can help the immune system attack cancer. All therapies have the potential to result in adverse reactions. See below for Important Safety Information on Opdualag.

Receiving an advanced melanoma diagnosis can be overwhelming, especially if it’s uncharted territory. However, understanding others’ experiences may help patients better navigate a diagnosis.

In 2022, Terry* was diagnosed with metastatic melanoma. As a U.S. veteran, an avid rider of his electric bike and someone who loves to travel and spend time with friends, Terry feared for what this diagnosis meant. He was concerned about the treatment journey ahead. After discussing treatment options with his healthcare team, Terry’s doctor recommended that he receive Opdualag.

Hear more from Terry about his experience and why dual IO was the right treatment for him, as well as expertise from Hussein A. Tawbi, MD, PhD, Melanoma Medical Oncologist, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center,** about navigating an advanced melanoma diagnosis and the importance of continued innovation.

Based on your experience with melanoma, how has your treatment journey impacted your life?

Terry: My diagnosis changed my life.

I’m honored that I was the first patient at the Veterans Affairs (VA) to receive Opdualag after it was approved by the FDA. The results were impactful for me, and treatment was mostly manageable where I experienced a little fatigue, afternoon tiredness, a rash on the back of my neck and a few itchy red blotches on my arm and chest. I’m glad I talked to my doctor about treatment options.

Terry’s results may not be typical. Opdualag may not work for everyone. Individual results may vary.

Why is it important that innovation continues for the treatment of advanced melanoma?

Dr. Tawbi: In the U.S., it is estimated that more than 100,000 new melanomas will be diagnosed in 2024 alone with advanced melanoma representing about 10% of all cases. These statistics stress the urgency for continued scientific innovations, such as dual IO, in cancer treatment.

Based on your personal experience, what would you tell someone who has been diagnosed with melanoma?

Terry: My biggest piece of advice is to find a doctor you trust and can have open and honest conversations with. Together, you and your doctor can develop a personalized treatment plan that you both feel is the right option for you.

Dr. Tawbi, what is your advice for newly diagnosed patients?

Dr. Tawbi: I encourage patients to promptly start a dialogue with their doctor to become more informed about the condition. It’s also important to lean on resources outside of the doctor’s office, such as family, friends and advocacy organizations. The more patients know about their condition, the more empowered they’ll feel to advocate for themselves and engage in treatment decision-making conversations with their doctors.

To learn more about Opdualag, visit www.opdualag.com and speak with your doctor.

*Terry is an actual patient who has been compensated by Bristol Myers Squibb for his role in the article.

**Dr. Tawbi has previously served as a clinical trial investigator and scientific advisor to Bristol Myers Squibb.

INDICATION:

Opdualag™ (nivolumab and relatlimab-rmbw) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or older who weigh less than 88 pounds (40 kg), or in children younger than 12 years of age.

Important Safety Information for Opdualag (nivolumab and relatlimab-rmbw)

What is the most important information I should know about Opdualag?

Opdualag is a medicine that may treat a type of skin cancer called melanoma by working with your immune system. Opdualag can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

• Lung problems: new or worsening cough; shortness of breath; chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
• Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
• Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area
• Heart Problems: new or worse chest pain; irregular heartbeat or feel like your heart is racing; shortness of breath; tiredness; swelling in your ankles

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Opdualag. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs
• Double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight
• Persistent or severe muscle pain or weakness; muscle cramps
• Low red blood cells; bruising

Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment with Opdualag. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop your treatment with Opdualag if you have severe side effects.

Possible side effects of Opdualag

Opdualag can cause serious side effects, including:

• See “What is the most important information I should know about Opdualag?”
• Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of Opdualag: chills or shaking; itching or rash; flushing; shortness of breath; dizziness; feel like passing out; fever; back or neck pain
• Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Opdualag. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of Opdualag include: muscle and bone pain; tiredness; decreased red blood cell and white blood cell counts; increased liver function test results; rash; itching, diarrhea; decreased salt (sodium) in your blood.

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

Before receiving Opdualag, tell your healthcare provider if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have a condition that affects your nervous system, such as myasthenia gravis, or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Opdualag can harm your unborn baby
  Females who are able to become pregnant:

• your healthcare provider should do a pregnancy test before you start receiving Opdualag
• you should use an effective method of birth control during and for at least 5 months after the last dose of Opdualag. Talk to your healthcare provider about birth control methods that you can use during this time
• tell your healthcare provider right away if you become pregnant during treatment with Opdualag
• are breastfeeding or plan to breastfeed. It is not known if Opdualag passes into your breast milk. Do not breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag

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

Please see U.S. Full Prescribing Information and Medication Guide for Opdualag.

© 2024 Bristol-Myers Squibb Company.

Opdualag™ and the related logo are trademarks of Bristol-Myers Squibb Company.

1425-US-2400197 12/24

2024-12-16T08:31:00

(BPT) – Expecting mothers have countless preparations to make before their little ones arrive, from decorating the nursery and installing a car seat to picking a pediatrician and thinking about maternal immunizations. For mom and actress Chloe Bridges, who is partnering with Pfizer, navigating pregnancy — and the choices that come along with it — was a little overwhelming.

“Looking back, I was facing so many decisions about how to help protect my baby. Everyone — my friends, my parents, my husband Adam’s parents, social media — had their own opinions,” said Bridges. “It was a lot.”

Now, when reflecting on her pre-birth planning, Bridges says she has ‘new mom clarity.’ One crucial decision she made during pregnancy was receiving ABRYSVO^® (Respiratory Syncytial Virus Vaccine), the only vaccine given to pregnant people at 32 through 36 weeks gestation to help protect infants from the risk of severe respiratory syncytial virus (RSV) from birth through six months.

What is RSV?

RSV is a highly contagious virus that can be dangerous for babies. In fact, RSV is the leading cause of hospitalization in infants in the U.S, with more than 50% of all RSV-related hospitalizations during the first year of life occurring within the first three months, and more than 75% occurring within the first six months.

The role of maternal immunization

During pregnancy, the mother’s body naturally passes antibodies, including those her body creates after receiving a vaccine, to the infant. That means mothers who are between 32 and 36 weeks pregnant can help protect their babies from the risk of RSV starting with their first breath by receiving the ABRYSVO vaccine.

“Expecting mothers are doing everything they can to prepare for the birth of their babies. It’s such a transformative and life-changing experience to have a baby,” said Bridges. “For me, speaking with my OB-GYN throughout my pregnancy journey helped me to make decisions that were right for me and Beau. She answered all my questions and provided me with so much information that I needed to prepare.”

An important maternal vaccine

If you’re pregnant and approaching the third trimester of pregnancy, consider asking your OB-GYN or other healthcare provider about ABRYSVO. Pfizer’s ABRYSVO is the first and only maternal RSV vaccine that helps protect newborns against RSV from birth through six months of age. To avoid the potential risk of preterm birth, ABRYSVO should be given at 32 through 36 weeks gestational age.

The Centers for Disease Control and Prevention (CDC) recommends ABRYSVO if you are 32 through 36 weeks pregnant from September through January (in most parts of the continental United States). Keep in mind that the recommended months for maternal vaccination might vary depending on your location.

Decide what’s best for you and your baby

“I wanted to help protect Beau from RSV from his first breath,” said Bridges. “I’m so glad I decided to get the vaccine for him while I was pregnant.”

Talk to your OBGYN or other healthcare provider to learn more about how to help protect your baby against RSV.

This article was sponsored by Pfizer. To learn more about the vaccine and deepen your knowledge about RSV and maternal immunization, visit ABRYSVO.com.

Important Safety Information and Use

WHAT IS ABRYSVO?

ABRYSVO is a vaccine indicated for pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
• To avoid the potential risk of preterm birth, ABRYSVO should be given at 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury due to fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In pregnant individuals, the most common side effects (≥ 10%) were pain at the injection site, headache, muscle pain, and nausea
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)

Ask your healthcare provider about the risks and benefits of ABRYSVO. Only a healthcare provider can decide if ABRYSVO is right for you. Always talk to your healthcare provider about any side effects you may experience.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Individuals who received ABRYSVO during pregnancy are encouraged to enroll in a pregnancy exposure registry at 1-800-616-3791. The registry will monitor pregnancy outcomes.

Please see full Prescribing Information for ABRYSVO.

PP-A1G-USA-1849 © 2024 Pfizer Inc. All rights reserved. November 2024.