Pronunciation: gaz-ee-vah
Generic name: obinutuzumab
Dosage form: single-dose vial for intravenous infusion (1000 mg)
Drug class: CD20 monoclonal antibodies

Medically reviewed by Carmen Pope, BPharm. Last updated on May 9, 2025.

What is Gazyva?

Gazyva is used to treat chronic lymphocytic leukemia (CLL) or follicular lymphoma (FL) in adults. It is administered as an intravenous infusion by a healthcare provider, 3 or 4 times during cycle 1, then on day 1 of subsequent cycles.

Gazyva (obinutuzumab) is a targeted immunotherapy treatment that works with your immune system to treat cancer. It is not chemotherapy, although it is usually given with chemotherapy treatments. It gained FDA approval on November 1, 2013.

FDA approvals and indications

Gazyva is approved for adults with:

• Previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil
• Follicular lymphoma (FL), who have relapsed after or are refractory to a rituximab-containing regimen. Used in combination with bendamustine, followed by Gazyva monotherapy
• previously untreated stage II bulky, III, or IV follicular lymphoma in combination with chemotherapy, followed by Gazyva monotherapy in patients achieving at least a partial remission. 

How does Gazyva work?

Gazyva works by targeting a protein called CD20 that appears on both normal and cancerous B-lymphocytes (lymphocytes are a type of white blood cell). By binding to this protein, Gazyva:

• Helps your immune system identify and destroy marked cells
• Directly attacks cancer cells
• Preserves stem cells in bone marrow, allowing your body to keep producing healthy blood cells.

Gazyva belongs to the drug class called CD20 monoclonal antibodies.

How effective is Gazyva?

Clinical trials have demonstrated that CLL patients receiving Gazyva plus chlorambucil experienced:

• Nearly 80% partial or complete response rate (versus 66.3% with rituximab plus chlorambucil)
• Approximately one additional year without cancer progression (26.7 months versus 14.9 months with rituximab plus chlorambucil).

Side effects

The most common side effects of Gazyva are:

• infusion-related reactions
• low white blood cell counts (neutropenia)
• fatigue
• nausea
• fever
• cough.

Serious side effects and warnings

Gazyva carries a boxed warning for hepatitis B Virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML).

• 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 this medicine 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 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. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.

Gazyva may also cause the following other serious side effects:

• Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any Gazyva infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. 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 IRR is life-threatening, the infusion will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have from the infusion process. You may be given medicines to take before each Gazyva treatment. Symptoms of IRRs may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
• Hypersensitivity Reactions including serum sickness: Some people receiving this medicine 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. This medicine 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 nausea, vomiting, diarrhea, and tiredness
• Infections: 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 this medicine 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 this medicine 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 a low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking this medicine, 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 this medicine. If your platelet count gets too low, your treatment may be delayed or reduced
• Disseminated intravascular coagulation (DIC): Fatal and severe DIC has been reported in people receiving Gazyva. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding.

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 this medicine should not receive live vaccines.

These are not all the possible side effects of Gazyva. For more information, ask your doctor or pharmacist. Tell your doctor right away about any side effects you experience. 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.

Related/similar drugs

Before receiving

Do NOT receive Gazyva if you've had an allergic reaction to obinutuzumab, Gazyva, or any of the ingredients in the injection.

Before receiving Gazyva, tell your healthcare provider about all your medical conditions, including if you:

• have heart disease
• have an infection, particularly hepatitis B
• have lung or breathing problems
• have recently received or plan to receive a vaccine
• take blood-thinning medications
• are pregnant or planning pregnancy
• are breastfeeding or planning to breastfeed.

Pregnancy

Gazyva may harm an unborn baby. Use effective contraception during treatment and for 6 months afterward.

If you become pregnant while taking this medicine, talk to your healthcare provider immediately. If you received Gazyva during pregnancy, you will also need to talk to your healthcare provider about the best time for your infant to receive their vaccinations. 

Breastfeeding

Breastfeeding is not recommended during treatment and for 6 months after the last dose due to potential risks to infants.

How do I receive Gazyva?

Gazyva is administered as an intravenous infusion in a clinic or infusion center. Most people will complete their treatment in about 6 months, although some may receive it every 2 months following the initial course for up to 2 years.

• Gazyva is usually administered over 3-5 hours.

• A shorter 90-minute infusion beginning in Cycle 2 is available if you do not have a severe or life-threatening infusion-related reaction during Cycle 1, given as a standard infusion. Ask your doctor if a shorter-duration infusion may be right for you.

• Treatment occurs only on certain days of each cycle and is usually followed by several weeks of rest and recovery.

• During the infusion process, some patients may experience side effects. You will be monitored for these.

• Speak with your doctor if you miss a dose.

Preparing for the infusion

One Week Before:

• Review all medications with your doctor
• Discuss blood pressure medications that might need adjustment.

Day of the Infusion:

• Arrange transportation home
• Wear comfortable clothing
• Bring snacks, entertainment, and activities
• Expect to spend most of the day at the facility.

Pre-Medications:

Your doctor may prescribe medications one hour before infusion to reduce side effects:

• Acetaminophen
• Antihistamines
• Steroids.

Previously untreated chronic lymphocytic leukemia

Gazyva is given for a total of 6 cycles, or rounds of treatment, in combination with chlorambucil. Each cycle will last 28 days. 

Relapsed or refractory follicular lymphoma

Gazyva in combination with bendamustine is given for a total of 6 cycles, or rounds, of treatment.

• Each cycle will last 28 days.
• If your disease has not progressed during the initial 6 cycles, your doctor may recommend Gazyva alone once every 2 months for 2 years.
• Treatment occurs only on certain days of each cycle, and is usually followed by several weeks of rest and recovery.

Previously untreated follicular lymphoma

Gazyva is given in combination with chemotherapy for a total of 6-8 cycles (depending on the chemotherapy).

• If you achieve a response after the first 6-8 cycles, your doctor may recommend Gazyva alone once every 2 months for up to 2 years.

Dosing information

Previously untreated chronic lymphocytic leukemia (CLL)

• Six 28-day cycles.

Gazyva dosing schedule for CLL

Cycle 1:

• Day 1: 100 mg
• Day 2: 900 mg
• Day 8: 1000 mg
• Day 15: 1000 mg

Cycles 2-6:

• Day 1: 1000 mg

You should receive chlorambucil on Day 1 and Day 15 of Cycles 1 through 6

Relapsed or refractory (r/r) follicular lymphoma

• Six 28-day cycles, when combined with bendamustine

Gazyva dosing schedule for r/r follicular lymphoma

Cycle 1:

• Day 1: 1000 mg
• Day 8: 1000 mg
• Day 15: 1000 mg

Cycles 2-6:

• Day 1: 1000 mg

You will receive bendamustine on days 1 and 2 of Cycle 1 through 6.

Previously untreated follicular lymphoma

Depending on the type of chemotherapy your doctor recommends, you will receive one of the following cycles of treatment:

• Six 28-day cycles, when combined with bendamustine
• Six 21-day cycles, followed by 2 additional 21-day cycles of Gazyva alone, when combined with CHOP (cyclophosphamide, doxorubicin, vincristine)
• Eight 21-day cycles, when combined with CVP (cyclophosphamide, vincristine, and prednisone).

Gazyva dosing schedule for previously untreated follicular lymphoma

Cycle 1:

• Day 1: 1000 mg
• Day 8: 1000 mg
• Day 15: 1000 mg

Cycles 2-6 or 2-8:

• Day 1: 1000 mg

Ongoing monitoring

During treatment, your doctor will regularly assess:

• Symptoms
• Lymph node, liver, and spleen size
• Blood counts
• Side effects.

What to avoid during treatment

Live vaccines: Do not receive BCG, MMR, MMRV, rotavirus, or varicella vaccines during Gazyva treatment

Ingredients

Active: obinutuzumab

Inactive: 20 mM L-histidine/L-histidine hydrochloride, 240 mM trehalose, 0.02% poloxamer 188. The pH is 6.0.

Gazyva is supplied as 1,000 mg single-dose vials (concentration 25 mg/mL).

Manufacturer

Gazyva is manufactured by Genentech, a subsidiary of Roche. Genentech is headquartered in South San Francisco, California, while Roche's global headquarters is in Basel, Switzerland.

Gazyva Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Gazyva.

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Further information

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