Obinutuzumab

Obinutuzumab is a prescription medication used to treat patients with chronic lymphocytic leukemia (CLL) or follicular lymphoma. Obinutuzumab belongs to a group of drugs called monoclonal antibodies. These work by helping the body slow or stop the growth of cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of obinutuzumab include infusion reactions, fever, and cough.

Obinutuzumab is a prescription medication used to treat patients with chronic lymphocytic leukemia (CLL) or follicular lymphoma. CLL and follicular lymphoma are types of cancer that affects your white blood cells. White blood cells help your body fight infections. It is also used to treat follicular lymphoma

Obinutuzumab may be found in some form under the following brand names:

• Gazyva

• infusion reactions
• low white blood cell counts
• low platelet counts
• anemia
• fever
• cough
• musculoskeletal (muscle and bone) disorder

This is not a complete list of obinutuzumab side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with obinutuzumab. See the "Obinutuzumab Precautions" section.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No obinutuzumab drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with obinutuzumab including the following:

• Infusion reactions. You may receive medication before treatment with obinutuzumab to prevent an infusion reaction.
• Tumor Lysis Syndrome (TLS). You will most likely receive medications and adequte fluids to prevent TLS.
• Low white blood cell count. Tell your healthcare provider if you develop signs and symptoms of an infection, including a fever or cough.
• Low platelet count. If your blood has a low number of platelets, you can be at risk for mild to serious bleeding.
• Immunization. Do not receive live virus vaccines before or during therapy with obinutuzumab.
• Hepatitis B virus (HBV) reactivation. Symptoms of hepatitis include worsening fatigue or yellow discoloration of skin or eyes.
• Neurological problems. New or changes in neurological symptoms include confusion, dizziness or loss of balance, difficulty talking or walking, or vision problems.

Do not take obinutuzumab if you are allergic to this medication or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of obinutuzumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking obinutuzumab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to obinutuzumab or to any of its ingredients
• have liver or kidney problems
• have had a hepatitis B infection in the past
• are pregnant or breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Obinutuzumab falls into category C. There are no well-controlled studies of obinutuzumab in pregnant women. Women who can become pregnant should use effective contraception while receiving obinutuzumab and for 12 months after treatment. Obinutuzumab should be used during pregnancy only if the potential benefit outweighs the potential risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if obinutuzumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using obinutuzumab.

Take obinutuzumab exactly as prescribed.

The recommended dose of obinutuzumab, for the treatment of chronic lymphocytic leukemia (CLL), is 1000 mg, administered intravenously. However, the dose given for the first infusions in cycle 1 are 100 mg (day 1) and 900 mg (day 2).

The recommended dose of obinutuzumab, for the treatment of follicular lymphoma, is 1000 mg, administered intravenously. However, the dose given for the first infusions in cycle 1 are 1000 mg (day 1, 8, and 15), cycle 2 through 6 to 8 are 1000mg (day 1), and then 1000 mg every 2 months for up to 2 years. 

If obinutuzumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including obinutuzumab. Screen all patients for HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with obinutuzumab. Discontinue obinutuzumaband concomitant medications in the event of HBV reactivation.
• Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving obinutuzumab.