Brentuximab Vedotin Solution for injection

What is this medicine?

BRENTUXIMAB VEDOTIN (bren TUX see mab ve DOE tin) is a monoclonal antibody and a chemotherapy drug. It is used for treating Hodgkin lymphoma and certain non-Hodgkin lymphomas, such as systemic anaplastic large cell lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• tingling of the fingers or toes, or other nerve disorder

• an unusual or allergic reaction to brentuximab vedotin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This medicine may interact with the following medications:

• ketoconazole

• rifampin

• St. John's wort; Hypericum perforatum

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for checks on your progress. This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your doctor right away. If you cannot reach your doctor, urgently seek other source of medical care.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in emotions or moods

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• pain, tingling, numbness in the hands or feet

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• shortness of breath

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• signs of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; yellowing of the eyes or skin

• stomach pain

• sudden numbness or weakness of the face, arm or leg

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• dizziness

• headache

• muscle pain

• nausea, vomiting

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.