obinutuzumab (Gazyva)

Brand Names: Gazyva

Generic Name: obinutuzumab

• What is obinutuzumab (Gazyva)?
• What are the possible side effects of obinutuzumab (Gazyva)?
• What is the most important information I should know about obinutuzumab (Gazyva)?
• What should I discuss with my healthcare provider before receiving obinutuzumab (Gazyva)?
• How is obinutuzumab given (Gazyva)?
• What happens if I miss a dose (Gazyva)?
• What happens if I overdose (Gazyva)?
• What should I avoid while receiving obinutuzumab (Gazyva)?
• What other drugs will affect obinutuzumab (Gazyva)?
• Where can I get more information (Gazyva)?

Obinutuzumab is a monoclonal antibody that affects the actions of the body's immune system. Obinutuzumab strengthens your immune system to help your body fight against tumor cells.

Obinutuzumab is used in combination with another cancer medicine called chlorambucil to treat chronic lymphocytic leukemia.

Obinutuzumab is also used in combination with other cancer medicines to treat follicular lymphoma (a type of non-Hodgkin lymphoma), or to help delay the progression of this disease.

Obinutuzumab may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives, rash; fever, joint pain; fast heartbeats, chest pain, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Obinutuzumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection, or within 24 hours afterward. Tell your caregiver if you feel feverish, chilled, tingly, light-headed, nauseated, or if you have diarrhea, chest pain, or trouble breathing.

Call your doctor at once if you have other side effects such as:

• fever, swollen glands, itching, joint pain, or not feeling well;
• pale skin, easy bruising, unusual bleeding;
• pain or burning when you urinate;
• cough with mucus, chest pain, feeling short of breath;
• right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes;
• dizziness, loss of balance or coordination;
• confusion, vision problems, problems with speech or walking; or
• signs of tumor cell breakdown--weakness, muscle cramps, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• fever, weakness, low blood cell counts;
• diarrhea, constipation;
• itching, hair loss;
• headache, joint pain;
• cough, runny or stuffy nose, sinus pain; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Obinutuzumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

You should not receive this medicine if you have ever had a severe allergic reaction to obinutuzumab, including a condition called serum sickness.

Tell your doctor if you have ever had:

• hepatitis B or other liver problems;
• kidney disease;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• high blood pressure; or
• if you have an active infection.

It is not known whether obinutuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Obinutuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Obinutuzumab is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with obinutuzumab.

On the days you receive this medicine, plan to spend most of the day at the hospital or infusion clinic.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Obinutuzumab can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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Call your doctor for instructions if you miss an appointment for your obinutuzumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while receiving obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven; or
• medicine to treat or prevent blood clots--cilostazol, clopidogrel, dipyridamole, ticagrelor, ticlopidine, and others.

This list is not complete. Other drugs may affect obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about obinutuzumab.

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