Monday, February 10, 2025

Fall into Seafood During National Seafood Month with 3 Easy Recipes

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Fall into Seafood During National Seafood Month with 3 Easy Recipes

(BPT) - October is here, which means fall is in full swing. It's a time of year when you can enjoy vibrant fall colors, football season and cooler weather that begs for cozy meals at home and warm comfort foods. But did you know that October is also National Seafood Month?

Whether you're cooking for family and friends or just for yourself, expand your culinary skills by adding seafood to your fall meal plans.

Why Seafood?

According to the Dietary Guidelines for Americans people of all ages should eat seafood at least twice a week. National Seafood Month is an awesome time to appreciate the variety of seafood available, try new flavors and incorporate more seafood into your diet.

Not sure how to start incorporating seafood into your meal plan? SeaPak (America's #1 Breaded Shrimp) offers three mouthwatering, quick and easy meals perfect to inspire your fall menu.

1. Popcorn Shrimp Flatbread Pizza

Popcorn shrimp is a sure-to-please crowd and kid favorite. Combine that with pizza, and you have a winning combination. This recipe for a crispy and flavorful flatbread pizza features ricotta, mozzarella, olives, arugula, parsley and SeaPak Popcorn Shrimp.

America's #1-selling Popcorn Shrimp is famous for a reason. With a crispy breading, these easy-to-bake and air fryer-friendly shrimp are perfect for everything from parties to meal planning.

2. One-Pot Creamy Shrimp Scampi

One-pot meals are easy to make, clean up and enjoy. This recipe for a One-Pot Creamy Shrimp Scampi takes five minutes to prepare and 25 minutes to cook. This no-fuss meal will impress your guests, and they'll never know it took only minutes to prep.

This quick, simple dish uses only seven ingredients: linguine noodles, spinach, half-and-half, parmesan, lemon wedges and shrimp scampi. The result? A velvety flavorful sauce, earthy spinach and buttery delicious shrimp.

3. Sheet Pan Jumbo Shrimp Fajitas

Impress your sweetheart this date night with Sheet Pan Jumbo Shrimp Fajitas. Combine spiced peppers, onions, seasoning and jumbo butterfly shrimp in a foil-lined baking sheet. Once done, you can serve the fajita mixture on steamed or charred flour tortillas and top with cilantro and avocado slices. Best of all? A one-pan meal means cleaning up takes little to no time so you can spend more time with your special someone.

Choose the right seafood products for memorable meals

When choosing seafood for your weekly meal plan, look for SeaPak. They offer versatility in cooking methods, allowing you to bake their products in the oven, sauté on the stovetop or fry in the air fryer.

Each package includes step-by-step, easy-to-follow instructions, so you'll never have to guess how to prepare your seafood and your meal will cook perfectly every time. You can use SeaPak products in any or all of these seafood recipes this fall.

Looking for a great deal on a seafood dinner? Find your favorite SeaPak products at a store near you by visiting SeaPak.com/Where-To-Buy/.

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Deserving More: Sherly's Journey to Managing Migraine Attacks

(BPT) - By Sherly P.

Coming of age in Puerto Rico, life was vibrant. As a family matriarch, I baked, cooked, and cared for 30+ relatives. My house was always the center of our family's activities. Unseen against the backdrop of family events, tables of food and the paradise that is Puerto Rico was my daily experience of living with migraine disease. I never allowed chronic migraine to slow down my education, career or impact my family, but it wasn't always easy.

Through my early 30s, my migraine attacks were mild and manageable. I earned two master's degrees, opened my own bakery, worked as a professional counselor and became a university professor. I also raised two rescue dogs, traveled the world, and maintained a busy social life.

Everything came to a crushing halt, and my migraine began to spiral out of control, after a serious injury in October 2012. I opened my eyes after an eight-hour surgery, but I didn't register the back pain because I was in the throes of the most excruciating migraine attack of my life. Immediately after surgery, my migraine symptoms intensified to include sensitivity to daylight, certain foods, and smells. Light sensitivity was impacting me so severely that I shifted to a nocturnal schedule to avoid daylight, making me feel like a vampire.

This rapid change started years of cycling through neurologists and various treatments in my desperate attempt to regain some control: acupuncture, vitamins, infrared light, yoga and even Himalayan sea salt in my coffee. Nothing worked for me.

Migraine pain became my new normal, robbing me of my health and happiness, and before long, the impact of my migraine disease was too much to bear. I lost my job, abandoned my studies, and retreated from family functions and socializing. The emotional low point came when my own loved ones accused me of exaggerating or faking my symptoms. The severity of it all led to self-isolation, anxiety, and depression. Medical professionals implied my suffering was just "in my head." I decided that I deserved more out of my migraine treatment plan and a neurologist who listened, believed, and validated the severity and impact of my migraine disease over my whole health. Finally, a recommendation led to a new neurologist who was both a migraine specialist and living with migraine herself. Finding her was my turning point as she combined migraine expertise with human empathy.

When I first visited her six years ago, she helped me understand the impact migraine was having on my life, and she was the first person in five years to validate the severity of my condition. I told her my migraine treatment plan wasn't working, and I needed to make a change. We developed an action plan to get a clearer picture of possible triggers for my migraine attacks. Armed with this information, we set out in search of a different treatment plan that would help address the severity of my disease and limitations. While I was in the waiting room for a follow-up appointment, I came across a brochure for VYEPTI^® (eptinezumab-jjmr), a prescription medicine used for the preventive treatment of migraine in adults. What jumped out at me with VYEPTI is that it's administered by a healthcare provider four times a year (every three months) via intravenous (IV) infusion. I brought the brochure to my neurologist to discuss it during our appointment. Together we discussed the potential benefits and risks of VYEPTI, and we decided to give it a try. After starting treatment with VYEPTI, I noticed my overall migraine symptoms were becoming less severe.

Finally, I started being able to go back out on my balcony and enjoy the sunshine. Before long, I was experiencing intervals where I would go three or four days without a migraine attack — a huge improvement.

In patients with 4 or more migraine days a month, VYEPTI has been proven to reduce monthly migraine days over months 1-3 compared to placebo. However, individual results may vary and you should 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.

With more migraine-free days, my house is once again the home to my family. I'm finally making plans! I'm even going to a concert soon, since it seems I can enjoy music again. I also plan to go back to school to get my Ph.D. in naturopathy. Migraine disease taught me the importance of putting myself first because I deserved more. With my migraine attacks less frequent and severe, I feel like my mental and physical health has improved. The biggest reward were the words from my therapist of 20 years, "finally, I see you again!"

Check out the doctor discussion guide on vyepti.com to get started today.

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.

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Ready-To-Use Glucagon Emphasized in Latest Diabetes Guidelines

(BPT) - If you or someone you care for is living with diabetes, you know it's important to stay up to date on the latest diabetes management guidelines. These updates for healthcare professionals from the American Diabetes Association (ADA) and the Endocrine Society highlight some key changes about who is at risk for low blood sugar, and what you should do if you are at increased risk.

What are the updates?

The ADA and Endocrine Society now say that you should have a prescription for ready-to-use glucagon if you are at risk of developing low blood sugar.^1,2 You're considered at risk if you take medications like insulin, sulfonylureas or meglitinides.

If that's you — or someone you care for — talk to your doctor today about your risk factors. Very low blood sugar is common, costly and life-threatening.² That's why the new guidelines recommend that those at high risk of low blood sugar have access to ready-to-use glucagon.

Glucagon is a hormone that helps raise blood sugar levels, and ready-to-use options provide ease of administration during a low blood sugar emergency. Even though the guidelines have been updated, many people living with diabetes, who should have ready-to-use glucagon, don't have it. The guidelines acknowledge that glucagon prescriptions are low, and that more needs to be done to protect those at risk.²

How to ensure your rescue plan aligns with the guidelines

Use the checklist below to make sure your diabetes toolkit is up to date.

Take a fresh look at your low blood sugar emergency plan. Does it include a ready-to-use glucagon option?
Learn about ready-to-use options like Gvoke HypoPen^® (glucagon injection), the ready-to-use rescue pen anyone can use³ with confidence.
Speak with your healthcare provider about your risk and if Gvoke HypoPen is right for you.
Get a prescription for ready-to-use glucagon and fill it right away.
Always keep it with you.
Educate friends, family, and coworkers about the signs and symptoms of low blood sugar and what they can do to support you should you experience a low blood sugar emergency in their presence. That includes where to find your rescue tool, when to use it, and how to use it.

Staying on top of evolving diabetes care guidelines is important. With the right plan in place, you can face very low blood sugar with confidence.

Learn more about Gvoke HypoPen.

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 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 healthcare provider about all your medical conditions, including if you:

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

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

HOW TO USE

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

HOW TO STORE

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

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

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

Please see the Full Prescribing Information for Gvoke

References:

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

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I choose GOVVI

A Chance at More Freedom - Living with Hemophilia B

(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.

Important Safety Information

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.

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From Uncertainty to Strength: Navigating Life with Cervical Cancer

(BPT) - Sponsored by Pfizer Inc. and Genmab A/S

It never occurred to Courtney that the difficulties she was having with sleeping and breathing could be cancer. Then, she was rushed to the emergency room and a CT scan revealed masses. Courtney, a 44-year-old pharmacy technician from Wilmington, North Carolina, was shocked to be diagnosed with Stage 3 cervical cancer.

"It was all just kind of a whirlwind, like, 'Oh my God. This is really happening,'" said Courtney. "Other than being screened for cervical cancer at my gynecologist, I knew hardly anything about it."

The American Cancer Society estimates that in 2024, there will be 13,820 new cases of cervical cancer diagnosed.ⁱ These numbers have improved since the mid-1970s due to advancements in vaccination and screening practices but, despite this progress, it's projected that this year about 4,360 women will die from the disease.ⁱ This underscores the need for more treatment options.

Following her initial diagnosis, Courtney began a treatment regimen, undergoing a hysterectomy and trying numerous therapies. When she progressed after first-line treatment, she was diagnosed with recurrent cervical cancer. "That was really scary. It was a very hard Thanksgiving that year."

When cervical cancer comes back (recurs) or spreads (metastasizes), treatment options are limited, and survival rates are as low as 19.4%.ⁱⁱ The outlook can feel bleak for patients and their loved ones. That's why for patients, particularly those like Courtney who are facing a challenging prognosis, having an open discussion with healthcare providers and ensuring full understanding of treatment options is critical. By staying informed and exploring all options, patients can take an active role in their care and overall treatment journey.

Courtney recalls taking to the internet, researching potential treatment options in between appointments. "TIVDAK^® (tisotumab vedotin-tftv) for injection came up, and I wanted to learn everything about it. I was excited to try something else, that could possibly work for me."

After much consideration, Courtney and her medical team chose TIVDAK as her next treatment option. TIVDAK is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have received chemotherapy that did not work or is no longer working. It is an antibody-drug conjugate (ADC), which attacks cells that have a special protein, called Tissue Factor. The special protein, Tissue Factor, is also present on some normal cells. So TIVDAK can still harm normal cells, which can cause side effects. In a clinical trial of 502 adult patients with cervical cancer that has returned or spread and who have received chemotherapy that did not or is no longer working, the patients in the TIVDAK group had a median overall survival of 11.5 months, versus 9.5 months for those treated with chemotherapy.

Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment. Serious side effects of TIVDAK may include eye problems, nerve problems (peripheral neuropathy), bleeding problems (hemorrhage), lung problems, and severe skin reactions. These are not all of the side effects of TIVDAK. Please see below for more Important Safety Information and click here for the full Prescribing Information with Medication Guide.

"[Since starting TIVDAK], I feel positive. I feel hopeful," Courtney says. "It was a really great option for me. I'm still on therapy." While these were Courtney's experiences at the time of publishing, TIVDAK will not work for everyone, and individual results may vary.

Having a support system was crucial for Courtney as she navigated treatment. In addition to feeling bolstered by her healthcare providers, husband, family and work colleagues, Courtney also found support in online patient and caregiver communities.

"It's been amazing the support that comes around you – sometimes from people you didn't even expect. It's been surprising and very encouraging. There are people working every day to help people just like me. I'm so thankful for that."

If you or a loved one has previously treated recurrent or metastatic cervical cancer, speak with your healthcare provider about whether TIVDAK could be part of your treatment plan.

What is TIVDAK?

TIVDAK is a prescription medicine used to treat adults with cervical cancer:

that has returned or has spread to other parts of the body, and
who have received chemotherapy that did not work or is no longer working.

IMPORTANT SAFETY INFORMATION

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

Eye problems are common with TIVDAK and can be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.

Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:

Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops
3 times a day for 3 days after each infusion
Use vasoconstrictor eye drops right before each infusion
Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK

Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

What are the possible side effects of TIVDAK?

Serious side effects of TIVDAK may include:

Eye problems. See "What is the most important information I should know about TIVDAK?"

Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK, including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or any unusual or heavy bleeding.

Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you have new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

Skin reactions that look like rings (target lesions)
Rash or itching that continues to get worse
Blistering or peeling of the skin
Painful sores or ulcers in your mouth, nose, throat, or genital area
Fever or flu-like symptoms
Swollen lymph nodes

The most common side effects of TIVDAK include:

Decreased red blood cell counts
Numbness or tingling in your hands or feet
Eye problems (conjunctival disorders)
Nausea
Tiredness
Changes in liver function blood tests
Nosebleed
Hair loss (alopecia)
Bleeding (hemorrhage)

Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving TIVDAK?

Tell your healthcare provider about all your medical conditions, including if you:

have a history of vision or eye problems
have numbness or tingling in your hands or feet
have bleeding problems
have liver problems
are pregnant or plan to become pregnant; TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK
are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

Females who can become pregnant:

- Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK
- Use an effective method of birth control during your treatment and for at least 2 months after the last dose of TIVDAK

Males with female partners who can become pregnant:

- Use effective birth control during treatment and for 4 months after the last dose of TIVDAK

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

These are not all of the possible side effects of TIVDAK. Discuss side effects with your healthcare provider. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information with Medication Guide about TIVDAK including an IMPORTANT WARNING here.

The patient featured in this article is receiving or has received TIVDAK. The patient was compensated by Pfizer/Genmab to share their story. These were their experiences at the time they were interviewed. TIVDAK will not work for everyone. Individual results may vary.

Courtney was compensated for her participation.

Content sponsored and provided by Pfizer and Genmab. Courtney partnered with Pfizer and Genmab to share her experience with recurrent/metastatic cervical cancer.

i American Cancer Society. (n.d.). Key statistics for cervical cancer. Retrieved September 6, 2024, from https://www.cancer.org/cancer/types/cervical-cancer/about/key-statistics.html.

ii National Cancer Institute SEER Program. "Cervical Cancer Statistics." seer.cancer.gov. Retrieved September 6, 2024, from https://seer.cancer.gov/statistics/.

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Monday, February 10, 2025