Obinutuzumab, Infusion

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KEY POINTS

• This medicine is given by IV to treat chronic lymphocytic leukemia.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine increases your risk of brain infection, liver injury, and severe skin problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: CD20-directed cytolytic antibody; monoclonal antibody; anticancer

Generic and brand names: obinutuzumab, infusion; Gazyva

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a vein) to treat chronic lymphocytic leukemia (CLL). It is used along with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from diseases such as HIV/AIDS, leukemia, lymphoma, or from cancer treatment, organ transplant medicine, or steroid medicine
• Hepatitis B or any liver disease
• Heart disease
• Low or high blood pressure
• Lung disease
• Progressive multifocal leukoencephalopathy (PML)

Tell your healthcare provider if you currently have an infection such as the flu or an open cut or sore, or if you often have infections that come back. Also tell your healthcare provider if you have recently had or are scheduled to have any kind of vaccination.

Also, tell your healthcare provider if you take any medicines for high blood pressure. Your healthcare provider may tell you to not take them for 12 hours before treatment with this medicine and for 1 hour after each infusion until your blood pressure is stable. Talk with your healthcare provider about this.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Use effective birth control while you are receiving this medicine and for 12 months after stopping this medicine. Talk with your healthcare provider about effective birth control. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

The infusions are given by your healthcare provider. You will be watched carefully during and after you receive each dose.

Your provider may tell you to take certain medicines before each infusion to help reduce any side effects. Follow your healthcare provider's directions exactly.

This medicine causes a temporary drop in blood pressure. If you are taking medicine for high blood pressure, your healthcare provider may tell you not to take it for 12 hours before receiving a dose of this medicine. Taking both medicines together could cause your blood pressure to become too low.

Your healthcare provider may prescribe other medicines to prevent infection while you are receiving this medicine. Take all medicines exactly as prescribed.

Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects you.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments. Talk with your healthcare provider about this.

You may have a severe reaction to the infusion. This can happen during your infusion or within 24 hours after an infusion of this medicine. Tell your healthcare provider right away if you have any of these symptoms during or after an infusion:

• Hives, rash, or Itching
• Swelling of your lips, tongue, throat, or face
• Sudden cough or shortness of breath
• Weakness, dizziness, or feeling faint
• Chest pain or irregular or fast heartbeat

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. If you notice new or sudden changes in thinking, walking, talking, or seeing, or sudden weakness on one side of your body, contact your healthcare provider right away.

If you have had hepatitis B or are a carrier of hepatitis B virus, this medicine could cause the virus to become active again. This may cause life-threatening liver problems.

This medicine may cause severe skin problems or a problem called tumor lysis syndrome. Tell your healthcare provider right away if you get painful sores or ulcers on your skin, lips, or in your mouth, peeling skin, rash, or blisters.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever (over 100°F, or 37.8°C), cough, or other signs of infection, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual tiredness or weakness; unusual bruising or bleeding; chest pain; dizziness; fast or irregular heartbeat; severe dizziness or fainting; pain when urinating or decreased urination; fever; cough; sore throat; trouble breathing; severe irritation, rash, peeling, or blisters; confusion; yellowing of the skin or eyes; dark urine; light-colored bowel movements; severe nausea, vomiting, diarrhea, or stomach pain.

Other: Mild diarrhea, nausea, or vomiting; headache; back pain; joint or muscle pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), dipyridamole/aspirin (Aggrenox), edoxaban (Savaysa), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.