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): Hepatitis B can cause liver failure and death. If you have a patient has had history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if you have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to monitor for hepatitis during and after your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put you 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: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If a patient has a reaction, the infusion is either slowed or stopped until the patient’s symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is serious, the infusion of GAZYVA will be permanently stopped. The patient’s healthcare team will take a few steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Signs of infusion reactions may include: dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, chest pain
- Tumor Lysis Syndrome (TLS): GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness
- Infections: While a patient is taking GAZYVA, the patient may develop infections. Some of these infections may be severe, so the patient should be sure to talk to the doctor if the patient thinks the patient has one. Patients with active infection should not be treated with GAZYVA. Infections may continue even after the patient stops taking GAZYVA. The patient’s doctor may prescribe medications to help prevent infections. Symptoms of infection include fever and cough
- Low White Blood Cell Count: When a patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, the patient’s doctor will do blood work to check the patient’s white blood cell counts. Neutropenia can develop during or after treatment of GAZYVA. It may also last for more than one month. If a patient’s white blood cell count is low, the patient’s doctor may prescribe medication to help prevent infections
- Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in the blood. This may affect the clotting process. While the patient is taking GAZYVA, the patient’s doctor will do blood work to check 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, the patient should tell the patient’s healthcare provider if the patient has recently received or is scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines
Pregnancy: A patient should tell the doctor if the patient is pregnant, plans to become pregnant, or is breastfeeding. It is not known if GAZYVA may harm the patient’s unborn baby or pass into the patient’s breast milk. The patient should use birth control while using GAZYVA and for 12 months after treatment. The patient should speak to the doctor about discontinuing GAZYVA if the patient is breastfeeding
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.