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Overview: Gazyva is used to treat certain types of blood cancer. It activates the immune system to help kill cancer cells. Common side effects include infusion reactions, low levels of neutrophils, tiredness, common cold symptoms, muscle or joint pain, constipation, and diarrhea. Keep all appointments to have your blood checked even after you stop using this medicine. Contact your health care provider right away or get emergency help if you have yellowing of your skin or eyes, changes in thinking or vision, trouble walking or speaking, seizures, fever or chills, infection, swelling, bleeding, bruising, sudden weakness, or trouble breathing.

Uses

What is Gazyva used for?

Gazyva (obinutuzumab) is commonly used to treat the following types of cancer.

Gazyva may also be used for other conditions as determined by your health care provider.

How does Gazyva work (mechanism of action)?

Gazyva attaches to a protein called CD20 that is found on the surface of certain immune cells known as B cells, which can be normal or cancerous. This binding activates the immune system to help kill the cancer cells.

How is Gazyva supplied (dosage forms)?

Gazyva is available in an injectable form that is given by a health care provider.

How should I store Gazyva?

Gazyva is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Gazyva?

The most common side effects of Gazyva are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Infusion reactions (see below)
  • Low neutrophil levels (neutropenia, see below)
  • Tiredness
  • Cough
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Muscle or joint pain
  • Constipation
  • Diarrhea

There may be other side effects of Gazyva that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Gazyva?

While less common, the most serious side effects of Gazyva are described below, along with what to do if they happen.

Severe Allergic Reactions. Gazyva may cause allergic reactions, which can be serious. These reactions can happen right away or can be delayed, which is called serum sickness. Get help right away if you have any of the following symptoms of a serious allergic reaction or serum sickness.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Chest pain

Infusion Reactions. Gazyva can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away or get emergency help if you have any of the following symptoms when you get your infusion or within a day of getting this medicine.

  • Fever or chills
  • Dizziness
  • Nausea or vomiting
  • Diarrhea
  • Shortness of breath
  • Chest pain

Hepatitis B Virus Reactivation. If you have the hepatitis B virus in your body or have had hepatitis B in the past, Gazyva could make the virus active again. If the virus becomes active, you can get life-threatening liver failure. Keep all appointments for blood tests before starting Gazyva and during treatment. Call your health care provider right away if you have any of the following symptoms of hepatitis.

  • Unusual tiredness
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Nausea, vomiting, or loss of appetite
  • Dark-colored pee
  • Fever or chills
  • Pain in your side
  • Clay-colored stool (poop)

Progressive Multifocal Leukoencephalopathy (PML). People using Gazyva may get a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • A hard time walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Tumor Lysis Syndrome. Gazyva can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be life-threatening. It is important to drink plenty of water while receiving Gazyva and to keep all appointments for blood tests so that your health care provider can see how your body is responding to Gazyva. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while using Gazyva.

  • Nausea, vomiting, or diarrhea
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Infections. Gazyva can increase your risk of infections, including serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee
  • Coughing, or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Low Neutrophil Levels (Neutropenia). Gazyva may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Keep all appointments to have your blood checked even after you finish using this medicine. Take any medicines you may be given to help prevent an infection. Tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Severely Low Platelet Levels. Gazyva can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding, including life-threatening bleeding. Make sure that your health care provider knows about all of your medicines, including over-the-counter (OTC) products like aspirin. Tell your health care provider if you have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds

Clotting Problems (Disseminated Intravascular Coagulation). Gazyva can cause a condition called disseminated intravascular coagulation (DIC), which can affect the body’s ability to form blood clots. DIC can be serious and even life-threatening. In the first stage of DIC, a lot of small blood clots form throughout your body, which uses up the supplies your body needs to stop bleeding. In the second stage of DIC, you start to bleed uncontrollably because your body has used up all of its clotting abilities. Get emergency help if you have any of the following symptoms of DIC.

  • Uncontrollable bleeding
  • Bruising
  • Vomiting
  • Blood in your stool (poop)
  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Warnings & Precautions

Who should not use Gazyva?

Allergies to Ingredients. People who are allergic to any of the following should not use Gazyva.

  • Gazyva
  • Obinutuzumab
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Gazyva.

What should I know about Gazyva before using it?

Gazyva is usually given by a health care provider in a hospital or clinic.

Gazyva can make you feel tired and affect your alertness. Do not drive or do other activities that require alertness or coordination until you know how Gazyva affects you.

People who are 65 and older can be at greater risk of some side effects from Gazyva. Talk to your health care provider about your risks if you are in this age group.

If you can get pregnant, use effective birth control while using Gazyva and for six months after your last dose. Talk to your health care provider about your birth control options.

What should I tell my health care provider before using Gazyva?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Gazyva is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • An active infection or an infection that keeps coming back
  • Tuberculosis (TB)
  • Hepatitis B
  • Heart problems
  • Lung problems
  • Kidney problems

Vaccines. Talk to your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Gazyva. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. Gazyva can harm a fetus. Your health care provider will likely do a test to make sure you are not pregnant before starting Gazyva. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed during treatment with Gazyva and for six months after your last dose. It is not known if Gazyva passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Gazyva?

For more information about Gazyva, you can visit the drugmaker’s website at www.gazyva.com or call them at 877-436-3683.

Interactions

Does Gazyva interact with foods or drinks?

There are no known interactions between Gazyva and foods or drinks.

There are no known interactions between Gazyva and alcohol, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Gazyva interact with other medicines (drug interactions)?

There are no known interactions between Gazyva and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Gazyva?

If you or someone else has used too much Gazyva, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Gazyva?

Gazyva is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Gazyva as scheduled.

If you miss an appointment to get your Gazyva dose, call to make another appointment as soon as possible.

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