Obinutuzumab (oh-bi-nue-TOOZ-ue-mab)

Treats chronic lymphocytic leukemia (CLL) and follicular lymphoma.

Brand Name(s):

Gazyva

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control during treatment and for 6 months after your treatment ends.
• Do not breastfeed during treatment and for 6 months after your treatment ends.
• Tell your doctor if you have low blood pressure, kidney disease, heart disease, lung problems, an infection, or a history of hepatitis B infection.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  • Reactivation of hepatitis B infection
  • Progressive multifocal leukoencephalopathy (a brain infection that can be life-threatening)
  • Infusion reaction
  • Tumor lysis syndrome (electrolyte and metabolic problem that can be life-threatening)
  • Blood clotting problem, including disseminated intravascular coagulation (DIC)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Confusion, problems with vision, speech, or walking
• Dark urine or pale stools, nausea, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea, nausea, vomiting, unusual tiredness
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088