Obinutuzumab Injection

Why is this medicine prescribed?

Obinutuzumab injection is to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells), follicular non-Hodgkin's lymphoma (NHL; a slow-growing blood cancer), and lupus nephritis (a disease in which the immune system attacks the kidneys). Obinutuzumab injection is in a class of medications called monoclonal antibodies. It treats CLL and NHL by killing cancer cells. It treats lupus nephritis by blocking the action of certain immune cells that may cause kidney damage.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Obinutuzumab injection comes as a solution (liquid) to be slowly injected intravenously (into a vein) by a doctor or nurse in a medical office or hospital. Your doctor will tell you how often you will receive obinutuzumab injection. The schedule depends on the condition you have and on how your body responds to the medication.

Obinutuzumab injection may cause a severe reaction during or shortly after the infusion of the medication. Your doctor will give you other medications before each infusion to prevent certain side effects. A doctor or nurse will watch you carefully while you are receiving the medication. If you experience any of the following symptoms, tell your doctor immediately: dizziness, lightheadedness, fainting, fast heartbeat, chest pain, difficulty breathing, swelling of the throat, nausea, vomiting, fatigue, diarrhea, sudden reddening of the face, neck, or upper chest, rash, hives, headache, chills, and fever.

Your doctor may need to delay or stop your treatment, or treat you with additional medications if you experience certain side effects. Talk to your doctor about how you are feeling during your treatment with obinutuzumab injection.

What special precautions should I follow?

Before receiving obinutuzumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any medications for high blood pressure. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had heart, lung, kidney, or liver disease. Also tell your doctor if you have any type of infection now or if you have or have ever had an infection that would not go away or an infection that comes and goes.
• tell your doctor if you are pregnant or plan to become pregnant. You should use effective birth control to prevent pregnancy during your treatment with obinutuzumab injection and for 6 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving obinutuzumab injection, call your doctor. Obinutuzumab injection may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving obinutuzumab and for 6 months after your final treatment dose.
• do not have any vaccinations without talking to your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving obinutuzumab injection.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you miss an appointment to receive obinutuzumab, call your doctor right away.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Obinutuzumab injection may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• muscle or joint pain
• constipation
• diarrhea
• unusual tiredness or weakness
• headache
• difficulty falling asleep or staying asleep
• decreased appetite
• itching

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or HOW section, call your doctor immediately or get emergency medical treatment:

• fever, chills, cough, sore throat, painful or frequent urination, or other signs of infection
• unusual bleeding or bruising
• pain, tenderness, or redness in one leg
• shortness of breath, new or worsening cough, coughing up blood
• stomach area pain, nausea, vomiting, fever, or chills
• chest pain, joint pain, and fever

Obinutuzumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What other information should I know?

Ask your pharmacist any questions you have about obinutuzumab injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.