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.

Gazyva may also be used for purposes not listed in this medication guide.

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.

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).

FDA pregnancy category C. 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

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.

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.

What should I avoid?

Do not receive a "live" vaccine while using Gazyva. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Gazyva side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy or nauseated, or have chest pain, trouble breathing, vomiting, or diarrhea.

Tell your caregiver right away if you have:

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• dizziness, confusion, vision problems, loss of balance or coordination, problems with speech or walking;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common Gazyva side effects may include:

• fever;

• cough; or

• muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Gazyva?

Other drugs may interact with obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.