What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effect you 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 history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B.
Symptoms of hepatitis include:
- Worsening of fatigue
- Yellow discoloration of skin or
Progressive Multifocal Leukoencephalopathy (PML)
PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms.
Symptoms of PML include:
- Difficulty talking or walking
- Dizziness or loss of balance
- Vision problems
Who should not receive GAZYVA?
- Do NOT receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past
What are the additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life threatening, including:
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 you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again.
However, if the infusion reaction is life threatening, the infusion of GAZYVA will be permanently stopped:
- Your healthcare team will take steps to help lessen any side effects you may have to the infusion process
- You may be
given medicines to take before each GAZYVA treatment
Symptoms of infusion reactions may include:
- Fast heartbeat
- Redness of the face
- High blood pressure
- Low blood pressure
- Difficulty breathing
- Chest discomfort
Hypersensitivity Reactions Including Serum Sickness
Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA.
Tumor Lysis Syndrome (TLS)
Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. 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. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS.
Symptoms of TLS may include:
While you’re taking GAZYVA, you may develop infections. Some of
these infections may be fatal and severe, so be sure to talk to your
doctor if you think you have an infection. Patients administered
GAZYVA in combination with chemotherapy, followed by GAZYVA alone are
at a high risk of infections during and after treatment. Patients with
a history of recurring or chronic infections may be at an increased
risk of infection. Patients with an active infection should not be
treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be
at higher risk for fatal or severe infections compared to patients
taking GAZYVA plus CHOP or CVP.
Low White Blood Cell Count
When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your 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 you have in your blood; having low platelet count
is called thrombocytopenia. This may affect the clotting process.
While you are taking GAZYVA, your doctor will do blood work to check
your platelet count. Severe and life-threatening thrombocytopenia can
develop during treatment with GAZYVA. Fatal bleeding events have
occurred in patients treated with GAZYVA. If your platelet count gets
too low, your treatment may be delayed or reduced.
The safety of GAZYVA was evaluated based on 392 patients with
relapsed or refractory NHL, including FL (81%), small lymphocytic
lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which
GAZYVA is not indicated), who did not respond to or progressed within
6 months of treatment with rituximab product or a rituximab
product-containing regimen. In the population of patients with FL, the
profile of adverse reactions was consistent with the overall NHL
population. The most common side effects of GAZYVA were infusion
reactions, low white blood cell counts, nausea, fatigue, cough,
diarrhea, constipation, fever, low platelet counts, vomiting, upper
respiratory tract infection, decreased appetite, joint or muscle pain,
sinusitis, low red blood cell counts, general weakness, and urinary
What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines.
Tell your doctor if you are pregnant, think that you might be
pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may
harm your unborn baby. Speak to your doctor about using GAZYVA while
you are pregnant. Talk to your doctor or your child’s doctor about the
safety and timing of live virus vaccinations to your infant if you
received GAZYVA during pregnancy. It is not known if GAZYVA may pass
into your breast milk. Speak to your doctor about using GAZYVA if you
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.
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.