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Gazyva is the brand name for obinutuzumab IV infusion.

Gazyva is available as a 1,000 mg/40 mL (25 mg/mL) single-dose vial.

Gazyva is a monoclonal antibody that is used to treat:

• Chronic lymphocytic leukemia (CLL)
• Follicular lymphoma (FL)

Gazyva is a monoclonal antibody that attaches to specific proteins called CD20 on B cells. B cells are a type of white blood cell. They are a part of your immune system and help your body make antibodies. Cancer cells usually have more CD20 proteins than normal, healthy cells. When Gazyva attaches to CD20, an immune response gets triggered. Signals get sent out to attack and kill the cells that the medication is attached to. Gazyva can also signal the cancer cells to die directly.

This medication is an injection into a vein (intravenously or IV) that’s given by a healthcare provider. The typical dose is 1,000 mg per infusion. Gazyva is given weekly for the first 3 weeks in your first cycle. Then, it’s given every 3 to 4 weeks for future cycles, depending on your treatment regimen. Due to the risk for infusion reactions, your very first infusion will be split over 2 days, with 100 mg on the first day, then 900 mg on the second day.

Gazyva is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. Gazyva is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use.

Common side effects of Gazyva:

• Infusion-related reactions
• Infections of the nose, throat, or lungs
• Cough
• Muscle, bone, or joint pain
• Fever

Serious side effects are rare with Gazyva. Contact your healthcare provider immediately if you experience any of the following.

• Serious infusion-related or allergic reactions: throat tightness, trouble breathing, itching or hives, swelling, chest pain, fast heartbeat, dizziness, flushing, chills, fever
• Infections (general): repeated fevers, chills, cough, trouble breathing, severe diarrhea, vomiting, painful urination, urinating more often than usual
• Brain infection: changes in mood or behavior, difficulty concentrating, vision loss, weakness, facial drooping, issues with balance or walking
• Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool

• There are no major drug interactions listed for Gazyva. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Genentech, Inc.

Based on its mechanism of action and findings in animals, Gazyva can cause B-cell depletion in infants exposed to obinutuzumab. Females of reproductive potential to use effective contraception while receiving Gazyva and for 6 months after the last dose

• Obinutuzumab