Side Effect Reporting
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
What it Treats
GAZYVATM (obinutuzumab) is a prescription medicine used with the chemotherapy chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
Important Safety Information
Patients must tell their doctor right away about any side effects they experience. GAZYVA can cause side effects that can become serious or life-threatening including:
Hepatitis B Virus (HBV) Reactivation: Hepatitis B can cause liver failure and death. If a patient has had hepatitis B or is a carrier of HBV, receiving GAZYVA could cause the virus to become an active infection again. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to monitor for hepatitis during and after the patient’s treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening fatigue and yellow discoloration of skin or eyes.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus that can lead to severe disability and death. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.
Additional possible serious side effects of GAZYVA:
Patients must tell their doctor right away about any side effects they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
- Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions, including but not limited to severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If severe or life-threatening infusion reactions occur, the patient’s infusion will be stopped and the patient will not continue treatment with GAZYVA. Infusion reactions may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before the treatment that may help to reduce the patient’s risk of an infusion reaction. Other symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain.
- Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS may cause an abnormal heartbeat or kidney failure requiring the need for dialysis treatment. The patient’s doctor may do blood tests to check the patient for TLS and give the patient medicines before their treatment to help prevent TLS. Symptoms of TLS may include nausea, vomiting, diarrhea and tiredness.
- Infections: Serious bacterial, fungal, and viral infections can occur during and following GAZYVA therapy. Symptoms can include fever and cough. Patients with active infection should not be treated with GAZYVA. Patients with a history of recurring or chronic infections may be at increased risk of infection.
- Low White Blood Cell Count: When a person has an abnormally low white blood cell count, it’s called neutropenia. White blood cells help fight infections. Neutropenia can occur during treatment with GAZYVA and more than 28 days after the end of treatment. It may also last for more than 28 days. While a patient is taking GAZYVA, their doctor will check the patient’s white blood cell count. If a patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections.
- Low Platelet Count: When a person has an abnormally low platelet count, it’s called thrombocytopenia. Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets a patient has in their blood. This may affect the clotting process. While a patient is taking GAZYVA, their doctor will monitor the patient’s platelet count.
Most common side effects of GAZYVA
The most common side effects of GAZYVA are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, and muscle and joint pain.
Before receiving GAZYVA, patients should talk to their doctor about :
Immunizations: Before receiving GAZYVA therapy, patients must tell their healthcare provider if they have recently received or scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines.
Pregnancy: Patients must tell their doctor if patients are pregnant or planning to become pregnant, or are breastfeeding. It is not known if GAZYVA may harm the patient’s unborn baby or pass into the patient’s breast milk. The patient and her doctor should decide if the patient should discontinue GAZYVA or discontinue breastfeeding. Women should use birth control while using GAZYVA and for 12 months after treatment.
Patients must tell their doctor about any side effect that bothers them or that does not go away.
These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.
GAZYVA is available by prescription only.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit www.gazyva.com for the full Prescribing Information, including Boxed WARNING, for additional Important Safety Information.