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Gazyva

Generic Name: obinutuzumab (OH-bi-nue-TOOZ-ue-mab)
Brand Name: Gazyva

If you have had hepatitis B before or carry the virus, Gazyva can cause the virus to become active again. This can lead to severe and sometimes deadly liver problems. Your doctor will test you for hepatitis B before you start Gazyva and then watch you for hepatitis B infection, while you take Gazyva and for several months after you stop Gazyva. Do not take Gazyva if you have active hepatitis liver disease.

A rare viral infection of the brain (progressive multifocal leukoencephalopathy [PML]) can occur with the use of Gazyva in certain patients. PML is serious and sometimes fatal. Tell your doctor right away if you notice new or worsening medical problems, such as confusion, disorientation, or problems thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination.


Gazyva is used for:

Treating chronic lymphocytic leukemia (CLL) in combination with chlorambucil.

Gazyva is a monoclonal antibody. It works by lowering the number of certain types of white blood cells (B cells) in the body.

Do NOT use Gazyva if:

  • you are allergic to any ingredient in Gazyva
  • you have an infection

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Gazyva:

Some medical conditions may interact with Gazyva. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have symptoms of an infection (eg, chills, fever, persistent sore throat), an infection that will not go away or keeps coming back, a history of frequent infections, or a weakened immune system
  • if you have a history of hepatitis B; kidney, liver, lung, or blood problems; heart problems (eg, irregular heartbeat, chest pain); high or low blood pressure; or electrolyte problems
  • if you have had a recent vaccination or are scheduled to receive a vaccination
  • if you have developed an infusion reaction or heart or lung problems from a previous dose of Gazyva
  • if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with Gazyva. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines for high blood pressure because they may increase the risk of low blood pressure when you receive Gazyva

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gazyva may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gazyva:

Use Gazyva as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Gazyva must be administered in an appropriate medical setting under close medical supervision.
  • Do not use Gazyva if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Your doctor will give you other medicines before you receive Gazyva to help reduce the risk of an infusion reaction. Discuss any questions with your doctor.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Gazyva, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Gazyva.

Important safety information:

  • Gazyva may lower the ability of your body to fight infection. This may increase the risk of serious bacterial, fungal, or viral infections. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • A rare viral infection of the brain (PML) can occur with the use of Gazyva in certain patients. PML is serious and sometimes fatal. Signs of PML may include confusion, disorientation, or trouble thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination. Tell your doctor right away if you notice any of these effects.
  • Severe and sometimes fatal infusion reactions may occur with Gazyva. These reactions may occur while you receive Gazyva or within 24 hours after you receive it. Tell your doctor right away if you develop chest pain, chills, diarrhea, dizziness, fainting, fast or irregular heartbeat, fever, flushing, headache, nausea, shortness of breath, swelling (eg, lips, tongue, throat, face), throat irritation, trouble breathing, weakness, wheezing, or vomiting while you receive or after you receive Gazyva.
  • Serious liver problems may develop with the use of Gazyva in patients who have hepatitis B infection or who carry the hepatitis B virus. Tell your doctor right away if you develop signs of liver problems, including dark urine, pale stools, severe stomach pain, or yellowing of the eyes or skin.
  • A serious and possibly fatal condition called tumor lysis syndrome (TLS) can happen with Gazyva. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
  • Worsening heart problems have been reported in patients taking Gazyva. Sometimes these have been fatal. If you have heart problems, talk with your doctor.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Gazyva. Talk with your doctor before you receive any vaccine.
  • Gazyva may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Tell your doctor or dentist that you take Gazyva before you receive any medical or dental care, emergency care, or surgery.
  • Women who may become pregnant must use effective birth control while they use Gazyva and for 12 months after they stop using it. Check with your doctor if you have questions about effective birth control.
  • Lab tests, including kidney and liver function, complete blood cell counts, and blood electrolytes, may be performed while you use Gazyva and for several months after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Gazyva should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Gazyva can cause harm to the fetus. Do not become pregnant while you use Gazyva and for 12 months after you stop using it. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gazyva while you are pregnant. It is not known if Gazyva is found in breast milk. Do not breast-feed while taking Gazyva.

Possible side effects of Gazyva:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Muscle pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); fast or irregular heartbeat; red, swollen, peeling, or blistered skin; severe or persistent headache; symptoms of infection (eg, cold symptoms, such as runny nose; cuts, scrapes, or surgery sites that are red, warm, swollen, or painful; earache; headache; fever, chills, cough, or persistent sore throat; flu-like symptoms, such as tiredness or body aches; painful urination; white patches in the mouth or throat); unusual bleeding or bruising; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Gazyva:

Gazyva is usually handled and stored by a health care provider. Keep Gazyva out of the reach of children and away from pets.

General information:

  • If you have any questions about Gazyva, please talk with your doctor, pharmacist, or other health care provider.
  • Gazyva is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Gazyva or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gazyva. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gazyva. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Gazyva.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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