Your Doctor Can Help By Being Your Advocate

When Emmaly heard the words “you may have cancer,” it was the furthest thing from the mind of this 29-year-old professional.

What had started with coughing progressed to fluid in her heart and lungs, and quickly snowballed into a hospital visit and CT scans showing swollen lymph nodes. As the tests to confirm a diagnosis continued and different possibilities were eliminated, the reality of those words drew closer. It took a few weeks, and while the initial shock of her illness wore off, there was nothing anyone could say to her that made it easy to digest — the diagnosis was stage 4 classical Hodgkin lymphoma.

Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. Hodgkin lymphoma is most common in early adulthood (a person’s 20s), and the risk rises again in late adulthood (after age 55). According to the American Cancer Society, it is estimated that 8,110 patients in the United States will be diagnosed in 2019. It is also slightly more common in males than females, as well as those with a weakened immune system or family history of the disease.

With a diagnosis at hand, Emmaly and her doctor discussed her treatment options. When diagnosed with Hodgkin lymphoma, many people receive a chemotherapy regimen of Adriamycin, bleomycin, vinblastine and dacarbazine (ABVD). However, after reviewing her case, Emmaly’s oncologist suggested another treatment option. ADCETRIS® (brentuximab vedotin) is approved for the treatment of adults newly diagnosed with Stage 3 or 4 classical Hodgkin lymphoma in combination with chemotherapy (Adriamycin, vinblastine and dacarbazine [AVD]). In a large clinical study of over 1,000 patients, ADCETRIS was studied in combination with Adriamycin, vinblastine and dacarbazine (AVD) for stage 3 or 4 classical Hodgkin lymphoma against a standard chemotherapy regimen of ABVD. Results showed that patients were 23 percent less likely to receive additional treatment because cancer was still detected in the body, to die from cancer or other cause, or to have their cancer grow. ADCETRIS has an IMPORTANT WARNING for PROGRESSIVE MULTIFOCAL LEUKOENCEPHAOPATHY (PML), patients treated with ADCETRIS can have a rare, serious brain infection called PML. It can cause death. See additional Important Safety Information below.

Prior to FDA approval, patients were historically treated with a chemotherapy regimen that included bleomycin, while ADCETRIS in combination with chemotherapy is bleomycin-free.

Each individual Hodgkin lymphoma diagnosis is different, so it’s important to remember that patients should speak with their doctor about treatment options and side effects. ADCETRIS has side effects, and the most common side effects were nerve damage (peripheral neuropathy) that mostly involves numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor), a low number of white blood cells, nausea, constipation, vomiting, feeling tired, diarrhea, fever, hair loss, weight loss, stomach pain, a low number of red blood cells, and sores or swelling in the mouth. The most common serious adverse reactions are: low numbers of white blood cells accompanied by a fever, fever, low numbers of white blood cells, and pneumonia. For additional safety information please see the Important Safety Information below and full Prescribing Information including BOXED WARNING.

ADCETRIS + AVD is given every two weeks for up to six months. Emmaly received 12 rounds of this treatment for newly diagnosed Stage 3 or 4 Hodgkin lymphoma patients. “I worked closely with my oncologist to discuss my treatment options and determine the best course of action for my diagnosis,” Emmaly said. “As a result, I felt confident I was putting myself in a good position to receive the most appropriate care for me.”

During the early stages of treatment, Emmaly felt very weak and needed a lot of assistance to walk and get around the house. The road to recovery was not quick and had its up and downs, where Emmaly experienced several of the common side effects listed above, but hair loss was mentally the most difficult side effect for her. However, Emmaly was fortunate enough to have her mother by her side, as well as her oncologist and a network of family and friends supporting her along the way.

While there were moments in Emmaly’s cancer treatment journey that she questioned whether she and her doctor had made the right decision, being in remission was the ultimate reassurance.

“My doctor really got it. We faced this cancer obstacle together as a team, set a plan and did what we had to do to try to get me better,” said Emmaly. “I’m truly grateful for the support I received from my family, friends, and doctor, and am excited for the new experiences I’ve been able to have — like traveling and participating in a camp for those affected by cancer.”

Please see the Important Safety Information below and full Prescribing Information including BOXED WARNING. For more information on ADCETRIS, please visit ADCETRIS.com. To help you talk to your doctor about the best treatment option for your diagnosis, download a guide for Questions to Ask Your Doctor.

Indication

ADCETRIS^® (brentuximab vedotin) for injection is approved for the treatment of:

• Previously untreated Stage 3 or 4 cHL: Adult patients with newly diagnosed Stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy (adriamycin, vinblastine, and dacarbazine)

Important Safety Information

What is the most important serious safety information I should know about ADCETRIS?

• PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): Patients treated with ADCETRIS can have a rare, serious brain infection called PML. It can cause death. Symptoms can begin at different times after starting ADCETRIS treatment, some within 3 months after the first dose. Call your doctor if you have mood changes, confusion, dizziness or loss of balance, trouble talking or walking, vision changes, or if you feel weak or have weakness on one side of the body. PML could also be caused by other treatments or diseases that made your immune system weaker.

What should I avoid when receiving ADCETRIS?

• Do not take ADCETRIS with bleomycin because of possible serious side effects to the lungs.

What are the other possible serious side effects of ADCETRIS?

A serious side effect can be life-threatening or can lead to death. They may happen during treatment or after your treatment has ended.

Call your doctor right away if you have symptoms of a serious side effect or if your symptoms get worse. If you have a serious side effect, your doctor may delay or stop your ADCETRIS treatment.

• Nerve damage (peripheral neuropathy) that is mostly numbness or tingling in the hands or feet (sensory) and/or weakness in the arms or legs (motor). The nerve damage can get worse with more doses of ADCETRIS. Call your doctor if you have tingling, burning, or numbness in your hands or feet, changes in your sense of touch, or trouble moving your hands or feet.
• Allergic and infusion reactions during infusion or up to 24 hours after your ADCETRIS infusion. Call your doctor if you have fever, chills, rash, or breathing problems within 24 hours of your infusion.
• Blood problems such as a low number of white blood cells with or without fever, a low number of platelets, or a low number of red blood cells.
• Your doctor will do blood tests to check your blood cell levels during ADCETRIS treatment. If your levels are too low, your doctor may lower or delay your dose, stop your ADCETRIS treatment, or give you a medicine called G-CSF. G-CSF is meant to prevent you from having a low number of white blood cells.
• Infections such as pneumonia, bacteremia, and sepsis or septic shock can happen with ADCETRIS treatment. Call your doctor if you have a fever of 100.5°F or higher, chills, cough, or pain when you urinate.
• Tumor lysis syndrome can happen if you have a tumor that grows quickly or have many tumor cells in your body.
• Patients with severe kidney disease may have more side effects and deaths than patients with normal kidney function and should avoid treatment with ADCETRIS.
• Patients with moderate or severe liver disease may have more side effects and deaths than patients with normal liver function and should avoid treatment with ADCETRIS.
• Liver injury can happen after the first dose of ADCETRIS or after ADCETRIS treatment is stopped and started again. Call your doctor if you feel tired, do not feel like eating, have upper stomach pain, dark urine, or yellow skin and eyes (jaundice).
• Lung problems. Call your doctor if you have a new cough, a cough that gets worse, or feel out of breath.
• Skin problems called Stevens-Johnson syndrome and toxic epidermal necrolysis can happen. Call your doctor if you have rash, hives, sores in your mouth, or blistering or peeling skin.
• Gastrointestinal (GI) problems related to the pancreas, stomach, intestine, and colon can happen. If you have lymphoma that involves your stomach or intestine, you could have a higher risk of GI perforation (a hole in your stomach or intestine). Call your doctor if you have severe stomach pain, chills, fever, nausea, vomiting, or diarrhea.
• High blood sugar. Your doctor will test your blood during ADCETRIS treatment. If your blood sugar is high, your doctor may give you medicine to control it. Call your doctor if you need to urinate more often, are very thirsty, or have blurry vision.

What were the most common side effects in patients treated with ADCETRIS?

When used alone or together with chemotherapy, the most common side effects were:

• nerve damage (peripheral neuropathy)
• feeling tired
• nausea
• diarrhea
• a low number of white blood cells
• infection in the nose or sinuses
• fever
• constipation
• vomiting
• hair loss
• weight loss
• upper stomach pain
• a low number of red blood cells
• sores or swelling in the mouth and/or in the digestive tract

Contact your doctor if you have any other side effects that bother you or do not go away.

What should I tell my doctor before I start treatment with ADCETRIS?

• All your medical conditions, including if you have kidney, liver, or lung problems, an infection, or diabetes.
• If you are pregnant or plan to become pregnant. ADCETRIS may harm your unborn baby. If you can get pregnant, you should have a pregnancy test before starting ADCETRIS treatment. You should use effective birth control (contraception) during ADCETRIS treatment and for at least 6 months after your last dose of ADCETRIS. Talk to your doctor about birth control methods. Tell your doctor right away if you become pregnant or think you are pregnant during ADCETRIS treatment. Men with female partners who can get pregnant should use effective birth control during ADCETRIS treatment and for 6 months after the last dose.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed during your ADCETRIS treatment.
• All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADCETRIS and certain other medicines can affect each other.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.Please see full Prescribing Information with BOXED WARNING.

This content is brought to you by Seattle Genetics, the maker of ADCETRIS (brentuximab vedotin).

Individual experiences may vary and information shared in this article is not intended to replace discussions with your doctor. Talk to your doctor to see if ADCETRIS may be right for you.

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¹ American Cancer Society. Hodgkin Lymphoma Causes, Risk Factors, and Prevention. Available at https://www.cancer.org/content/dam/CRC/PDF/Public/8650.00.pdf. Accessed June 6, 2019.

² American Cancer Society. What is Hodgkin Lymphoma? https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html. Accessed June 6, 2019.

³ American Cancer Society. Key Statistics for Hodgkin Lymphoma. Available at https://www.cancer.org/CANCER/HODGKIN-LYMPHOMA/ABOUT/KEY-STATISTICS.HTML. Accessed June 6, 2019.

⁴ Connors JM, Younes A, Gallamini A, et al. Brentuximab vedotin plus chemotherapy in patients with advanced-stage classical Hodgkin lymphoma: evaluation of modified progression-free survival (PFS) and traditional PFS in the phase 3 ECHELON-1 study. Poster presented at the 60th Annual Meeting of the American Society of Hematology (ASH); December 1-4, 2018; San Diego, CA.

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