Gazyva is a monoclonal antibody that affects the actions of the body's immune system. Obinutuzumab strengthens your immune system to help your body fight against tumor cells.

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

Gazyva is also used in combination with other cancer medicines to treat follicular lymphoma (a type of non-Hodgkin lymphoma), or to help delay the progression of this disease.

If you've ever had hepatitis B, using Gazyva can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Gazyva may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, walking, or muscle movement.

Before taking this medicine

You should not receive Gazyva if you have ever had a severe allergic reaction to obinutuzumab, including a condition called serum sickness.

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

• high blood pressure;

• hepatitis B or other liver problems;

• kidney disease;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• if you have an active infection.

Do not use Gazyva if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

Do not breastfeed while using Gazyva, and for at least 6 months after your last dose.

Gazyva is given as an infusion into a vein. A healthcare provider will give you this injection.

Gazyva is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with Gazyva.

On the days you receive this medicine, plan to spend most of the day at the hospital or infusion clinic.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Gazyva can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

If you've ever had hepatitis B, using Gazyva can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

THERAPY CONSISTS OF SIX 28-DAY TREATMENT CYCLES IN COMBINATION WITH CHLORAMBUCIL:
-Cycle 1, Day 1: 100 mg IV at 25 mg/hr over 4 hours; do not increase the infusion rate
-Cycle 1, Day 2: 900 mg IV at 50 mg/hr if no infusion reaction occurred during the previous infusion and the rate can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr; if an infusion reaction occurred during the previous infusion, administer at 25 mg/hr and the rate can be escalated in increments of up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
-Cycle 1, Days 8 and 15 AND Cycles 2 through 6, Day 1: 1000 mg IV at 100 mg/hr if no infusion reaction occurred during the previous infusion and the final rate was 100 mg/hr or faster and the rate can be escalated in increments of 100 mg/hr every 30 minutes to a maximum rate of 400 mg/hr; if an infusion reaction occurred during the previous infusion, administer at 50 mg/hr and the rate can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
NOTE: If a dose is missed, administer it as soon as possible and adjust dosing schedule to maintain the time interval between doses. If appropriate, patients who do not complete the Cycle 1 Day 1 dose may proceed to the Cycle 1 Day 2 dose.

Usual Adult Dose for Follicular Lymphoma:

THERAPY REGIMENS FOR FOLLICULAR LYMPHOMA: />1) For patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen, administer Gazyva in combination with bendamustine in six 28-day cycles. Patients who achieve stable disease, complete response, or partial response to the initial 6 cycles should continue Gazyva 1000 mg as monotherapy for up to 2 years.
2) For patients with previously untreated follicular lymphoma, administer Gazyva with one of the following chemotherapy regimens:
-Six 28-day cycles in combination with bendamustine.
-Six 21-day cycles in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP), followed by 2 additional 21-day cycles of Gazyva alone.
-Eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Patients with previously untreated follicular lymphoma who achieve a complete response or partial response to the initial 6 or 8 cycles should continue Gazyva 1000 mg as monotherapy for up to 2 years.

DOSE TO BE ADMINISTERED DURING 6 TO 8 TREATMENT CYCLES, FOLLOWED BY GAZYVA AS MONOTHERAPY FOR PATIENTS WITH FOLLICULAR LYMPHOMA:
-Cycle 1, Day 1: 1000 mg IV at 50 mg/hr; the rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
-Cycle 1, Day 8 and Day 15 AND Cycles 2 through 6 on Day 1 OR 2 through 8 on Day 1 AND as monotherapy every 2 months for up to 2 years: 1000 mg IV at 100 mg/hr if no infusion reaction or a Grade 1 reaction occurred during the previous infusion and the final rate was 100 mg/hr or faster and the rate can be escalated in increments of 100 mg/hr every 30 minutes to a maximum rate of 400 mg/hr; if an infusion reaction of Grade 2 or higher occurred during the previous infusion, administer at 50 mg/hr and the rate can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
-If a planned dose is missed, administer it as soon as possible. During Gazyva and chemotherapy treatment, adjust the dosing schedule accordingly to maintain the time interval between chemotherapy cycles. During monotherapy, maintain the original dosing schedule for subsequent doses. Monotherapy should be initiated approximately 2 months after the last dose of Gazyva administered during the induction phase.

You should not receive Gazyva if you have ever had a severe allergic reaction to obinutuzumab, including a condition called serum sickness.

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

• high blood pressure;

• hepatitis B or other liver problems;

• kidney disease;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• if you have an active infection.

Do not use Gazyva if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

Do not breastfeed while using Gazyva, and for at least 6 months after your last dose.

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

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

Do not receive a "live" vaccine while receiving Gazyva. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction to Gazyva: hives, rash; fever, joint pain; fast heartbeats, chest pain, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Gazyva may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection, or within 24 hours afterward. Tell your caregiver if you feel sudden warmth, redness, tingly feeling, feverish, chilled, light-headed, nauseated, or if you have headache, pounding in your neck or ears, tiredness, rash, dizziness, diarrhea, vomiting, chest discomfort, or trouble breathing.

Call your doctor at once if you have other side effects such as:

• easy bruising, unusual bleeding, purple or red spots under your skin;

• weakness, cough, diarrhea, burning when you urinate;

• right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes;

• dizziness, loss of balance or coordination;

• confusion, vision problems, problems with speech or walking;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

• signs of tumor cell breakdown - tiredness, muscle cramps, nausea, vomiting, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Gazyva side effects may include:

• a reaction during or shortly after the injection;

• tiredness;

• low white blood cell counts;

• diarrhea, constipation;

• muscle or joint pain; or

• cold symptoms such as stuffy nose, sneezing, cough, sore throat.

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.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven; or

• medicine to treat or prevent blood clots - cilostazol, clopidogrel, dipyridamole, ticagrelor, ticlopidine, and others.

This list is not complete. Other drugs may interact wth obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.