Gazyva

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

What is Gazyva?

Gazyva (obinutuzumab) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Gazyva is used in combination with another cancer medicine called chlorambucil to treat chronic lymphocytic leukemia (CLL).

Gazyva is also used in combination with a cancer medicine called bendamustine to treat follicular lymphoma (a type of non-Hodgkin lymphoma).

Important information

If you have ever had hepatitis B, Gazyva can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

 2016 New Drug Approvals: The Year That Was

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2016 New Drug Approvals: The Year That Was

Gazyva may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.

Before receiving this medicine

You should not receive Gazyva if you are allergic to obinutuzumab.

To make sure Gazyva is safe for you, tell your doctor if you have:

hepatitis B or other liver problems;

heart disease;

high blood pressure;

an active or recent infection; or

if you take a blood thinner (warfarin, Coumadin, Jantoven), or other medicine used to prevent blood clots (clopidogrel, Plavix, Ticlid, and others).

It is not known whether Gazyva will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether obinutuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is Gazyva given?

Gazyva is injected into a vein through an IV. A healthcare provider will give you this injection.

Gazyva is given in a 28-day treatment cycle, and you may only need to take the medicine during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to prevent certain side effects of Gazyva.

Obinutuzumab can lower blood cells that help your blood to clot. This can make it easier for you to bleed from an injury. Your blood may need to be tested often.

If you have ever had hepatitis B, Gazyva can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Gazyva injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

dosing information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Initial Cycle: 100 mg IV on Day 1, 900 mg IV on Day 2, then 1000 mg IV on Days 8 and 15.

-If appropriate, patients who do not complete the Initial Cycle, Day 1 dose may proceed to the Initial Cycle, Day 2 dose.

Subsequent Cycles: 1000 mg IV on Day 1 of each subsequent 28 day cycle

Duration of therapy: Gazyva is administered for 6 treatment cycles of 28 days each.

Comments:

-Premedicate before each infusion.

-Do not administer as an intravenous push or bolus.

-Monitor blood counts at regular intervals.

-Administer by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.

Approved indication:

-The treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil.