GAZYVA contains obinutuzumab, which is a humanized monoclonal antibody targeting the CD20 molecule on B cells. It belongs to the IgG1 subclass and is designed to be administered as an intravenous injection. The drug is available in a clear, preservative-free liquid concentrate with a concentration of 25 mg/mL, supplied in 1,000 mg single-dose vials. Key inactive ingredients include L-histidine, trehalose, and poloxamer 188.

How should I use this medication?

This medication is for infusion into a vein. It is given by a care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses as directed. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is only given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bone, joint, or muscle pain
• Constipation
• Diarrhea
• Fatigue
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Infection, especially a viral infection, such as hepatitis B
• Lung or breathing disease
• Take medications that treat or prevent blood clots
• An unusual or allergic reaction to obinutuzumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Report any side effects that you notice during your treatment right away, such as changes in your breathing, fever, chills, dizziness or lightheadedness. These effects are more common with the first dose.

Visit your care team for checks on your progress. You will need to have regular blood work. Report any other side effects. The side effects of this medication can continue after you finish your treatment. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

Call your care team for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medication decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Do not become pregnant while taking this medication or for 6 months after stopping it. Inform your care team if you wish to become pregnant or think you might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your care team or pharmacist for more information. Do not breast-feed an infant while taking this medication or for 6 months after stopping it.

What are the most serious risks of this medication?

This medicine can cause severe, life-threatening neurologic problems.

If you have ever had hepatitis B, you may get a flare-up or return of the hepatitis during use of this medicine. Your healthcare provider will monitor your liver function. You will need to discontinue this medicine and take other medicines if your hepatitis flares-up or returns.