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with ADCETRIS

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.

ADCETRIS is a prescription medicine directed against the CD30 protein. It is used to treat adult patients with:

• Newly diagnosed Stage 3 or 4 classical Hodgkin lymphoma in combination with chemotherapy (adriamycin, vinblastine, and dacarbazine)
• Classical Hodgkin lymphoma at high risk of coming back or becoming worse after a stem cell transplant
• Classical Hodgkin lymphoma after a stem cell transplant fails or after at least 2 combination chemotherapy treatments fail and stem cell transplant is not an option
• Newly diagnosed systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas, including angioimmunoblastic T-cell lymphoma and peripheral T-cell lymphomas not otherwise specified, in combination with chemotherapy (cyclophosphamide, doxorubicin, and prednisone)
• Systemic anaplastic large cell lymphoma after at least 1 combination chemotherapy treatment fails
• Primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy (treatment that reaches and affects the entire body)