Gazyva

What is Gazyva?

Gazyva, a monoclonal antigen, affects the immune system of the body. Obinutuzumab helps your body fight tumor cells by strengthening your immune system. Gazyva can be used with another cancer drug called chlorambucil in order to treat chronic lymphocytic leukemia. Gazyva can also be used with other cancer drugs to treat non-Hodgkin's lymphoma or to slow down the progression of this condition.

Warnings

Gazyva may cause hepatitis B to reactivate or worsen, if you have ever had it. If you feel unwell and have upper right stomach pain, nausea, loss of appetite, or yellowing skin or eyes, tell your doctor. Gazyva can cause a serious infection of the brain that may lead to death or disability. If you are experiencing problems with your speech, thinking, vision, walking, or muscle movements, call your doctor immediately.

Before you take this drug

If you've ever experienced a severe reaction to obinutuzumab (including a condition known as serum sickness), then you should not take Gazyva.

Tell your doctor about any of the following to ensure that you are safe when taking Gazyva:

• High blood pressure
• Hepatitis B and other liver diseases
• Kidney disease
• An electrolyte imbalance refers to low potassium or magnesium blood levels.
• If you have an infection that is active,

Do not use Gazyva if you are pregnant. This could harm your unborn child. While receiving treatment and up to six months after finishing taking your last dose of birth control. Do not breastfeed for 6 months after the last dose of Gazyva.

Similar/related drugs

Rituximab, Cyclophosphamide, Revlimid, Rituxan, Imbruvica, Lenalidomide, and Calquence

How to take Gazyva?

Gazyva can be infused into a vein. This injection will be given by a healthcare provider. Gazyva comes in a 28-day treatment cycle. You may only need to take the medication on certain days during each cycle. You will be treated by your doctor for the prescribed duration. Plan to spend the majority of your day in the hospital or at an infusion clinic on the days that you receive this medication. Other medications may be prescribed to prevent severe side effects or an allergic reaction. Continue to use these medications as prescribed by your doctor. Gazyva can reduce your blood count. You will have to test your blood frequently. The results may delay your cancer treatment. Gazyva may cause the virus to be active again or worsen if you have ever had hepatitis B. You may require frequent liver function testing while taking this medication and for several weeks after stopping.

Details on dosage

Adult dose for chronic lymphocytic leukemia:
The treatment consists of six 28-day cycles in conjunction with chlorambucil:
Cycle 1: Day 1: 100mg IV at 25 mg/hr for 4 hours. Do not increase the infusion rate.
Cycle 1, Day 2: 900mg IV at 50 mg/hr, if there was no reaction to the last infusion. The rate can then be increased by 50 mg/hr every 30 minutes up to 400 mg/hr. If an infusion response occurred in the previous infusion, you can administer the dose at 25 mg/hr.
Cycle 1: Days 8 and 15, and Cycles 2 to 6, Day 1, 1000 mg IV, 100 mg/hr. If no infusion reactions occurred in the previous infusions and the final rate is 100 mg/hr, The rate can then be increased in increments of 100 mg/hr every 30 minutes up to 400 mg/hr.
NOTE: If you miss a dose, give it as soon as you can and adjust the schedule so that there is a time interval between each dose. Patients who have not completed the Cycle 1 day 1 dose can proceed to the Cycle 1 day 2 dose if appropriate.
Adult dose for follicular lymphoma:
THERAPY REGIMENS FOLLICULAR LYMPHOMA: />1) For follicularly lymphoma patients who failed to respond or progressed after treatment with rituximab or a rituximab-containing regimen or during the first 6 months of that treatment, administer Gazyva with bendamustine over six cycles of 28 days. Gazyva 1000mg monotherapy can be continued for 2 years by patients who have achieved a complete or partial response after the first 6 cycles.
Gazyva can be administered with any of the following chemotherapy regimens for patients who have previously not been treated with follicular lymphoma:
Six 28-day cycles combined with bendamustine
Six cycles of 21 days in combination with cyclophosphamide (CHOP), vincristine, and prednisolone, followed by two additional cycles of 21 days using Gazyva
eight 21-day cycles in combination with cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone (CVP).
Gazyva is recommended for patients with previously untreated lymphoma follicular that have achieved a partial or complete response after the first 6 or 8 cycles.
GAZYVA IS TO BE ADMINISTERED AS A MONOTHERAPY IN PATIENTS WHO HAVE FOLLICULAR LYMPHOMA AFTER THE DOSE.
Cycle 1, Day 1: 1,000 mg IV at 50 mg/hr. The rate of infusion may be increased in increments of 50 mg/hr every 30 minutes up to 400 mg/hr.
Cycle 1, Day 8, and Day 15, AND Cycles 2–6 on Day 1 OR Cycles 2–8 on Day 1 AND As monotherapy every two months for up to two years: 1000mg IV at 100 mg/hr, if there was no infusion or Grade 1 reaction during the last infusion. The final rate should be 100 mg/hr. This rate can then be increased in 100 mg/hr increments every 30 minutes until a rate of 400 mg/hr is reached. If an infusion or Grade 2 reaction occurs, the previous infusion occurred, and the previous infusion was grade 2 or higher during the previous graded if the previous infusion a grade 2 or greater occurred during the prior infusion a grade 2 or higher during the previous a grade 2 or more than a grade 2 or higher during the
If a dose is missed during treatment, give it as soon as possible. Adjust the dosage schedule to maintain the interval between chemotherapy treatments when using Gazyva in conjunction with chemotherapy. Maintain the original schedule of subsequent doses during monotherapy. Monotherapy should begin approximately 2 months following the last dose administered by Gazyva during the induction period.

What happens if I miss the dose?

If you missed your appointment to receive your Gazyva, call your doctor and ask for instructions.

What happens if I overdose?

Call 1-800-222-1222 immediately if you suspect being affected by poison or seek immediate medical advice.

What should be avoided?

Gazyva should not be taken with a live vaccine. Live vaccines are measles (MMR), rubella, mumps (MMR), yellow fever, typhoid (chickenpox), varicella, or zoster (shingles).

Side effects of Gazyva

If you experience any of the following symptoms of an allergic reaction: hives or rash, fever, joint pain, fast heartbeats and chest pain, wheezing or difficulty breathing, swelling of the face, lips, throat, tongue, or mouth, call 911 immediately. Gazyva can cause a serious infection of the brain that may lead to death or disability. If you are having problems with your speech, thinking, vision, or muscle movements, call your doctor immediately. These symptoms can start slowly and worsen quickly. Some side effects can occur immediately after the injection or up to 24 hours later. You should tell your caregiver if there is sudden warmth, Redness or tingling could occur, particularly if you experience feverish, chilled, or light-headed feelings. Furthermore, other side effects could include easy bruising, abnormal bleeding, purple/red patches under your skin as well as other adverse reactions.

• You may experience weakness, diarrhea, or a burning sensation when you urinate.
• Right-sided upper abdominal pain, loss of appetite, yellowing skin or eyes
• Dizziness is a loss of coordination or balance.
• Having difficulty walking, confusion, or problems with vision;
• Low counts of white blood cells; fever; mouth sores and skin sores; sore throat; coughing; difficulty breathing
• Signs that tumor cells are breaking down: fatigue, muscle cramps nausea, vomiting, rapid or slow heart rate, or tingling around the mouth or hands.

Should certain side effects interfere with cancer therapy, your cancer treatments could be stopped or postponed.

Side effects of Gazyva include:

• A reaction that occurs during or soon after an injection.
• Tiredness;
• Low white blood cell count
• Diarrhea, constipation;
• Muscle or joint pain

Cold symptoms typically include stuffy noses, sneezing fits, coughs and sore throats. There may be additional side effects. To obtain medical advice regarding any adverse reactions, call your physician immediately or reach out to the FDA directly at 1-800-FDA-1088 to report it.

Interaction with other drug

As soon as possible, inform your physician of any medications, such as:

• A blood thinner Warfarin Coumadin Jantoven
• Medicines to treat or prevent blood clots: cilostazol (clopidogrel), dipyridamole (ticagrelor), ticlopidine, and others.

This list is incomplete. Other drugs, such as vitamins and herbs, may interact with obinutuzumab. This list does not encompass all potential drug interactions.