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 and Progressive Multifocal Leukoencephalopathy:
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 eyes
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
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 serious, 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
Signs of infusion reactions may include:
- Redness of the face
- Breathing problems
- Chest pain
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 severe. Fatal infections have been reported with GAZYVA, so be sure to talk to your doctor if you think you have one. Patients with active infection should not be treated with GAZYVA. Your risk for infections may continue even after you stop taking GAZYVA. Your doctor may prescribe medications to help prevent infections.
Symptoms of infection include:
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 or after treatment with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced.
The most common side effects of GAZYVA are:
- Infusion reactions
- Low white blood cell counts
- Low platelet counts
- Low red blood cell counts
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, 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 are breastfeeding.
Side effects in a clinical trial
The following side effects have occurred with GAZYVA infusions:
- Infusion reactions
- First 2 days of treatment—65%
- Later infusions—3%
- Low counts of certain cells within the blood
- White blood cells—38%
- Red blood
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.