Mosunetuzumab-axgb Injection

Mosunetuzumab-axgb injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusions. Your doctor will increase the dose of mosunetuzumab-axgb gradually with each infusion to ensure you are tolerating it. If you miss a dose, you may have to start the dosing schedule over again. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever (100.4°F or higher), chills, low blood pressure, fast or irregular heartbeat, tiredness or weakness, difficulty breathing, headache, confusion, anxiousness, dizziness, nausea or vomiting.

Mosunetuzumab-axgb injection is used to treat people with follicular lymphoma (FL; a slow-growing blood cancer) that has returned after being treated 2 or more times with other medications. Mosunetuzumab-axgb is in a class of medications called monoclonal antibodies. It works by killing cancer cells.

Mosunetuzumab-axgb injection comes as a solution (liquid) to be given intravenously (into the vein) by a doctor or nurse at a healthcare facility. It is usually given on days 1, 8 and 15 and then every 3 weeks thereafter for a minimum of 8 21-day cycles. You will be given different medications before treatment to help you tolerate mosunetuzumab-axgb injection.

Your doctor may delay or stop your treatment with mosunetuzumab-axgb, or treat you with additional medications, depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

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

Before receiving mosunetuzumab-axgb injection,

• tell your doctor and pharmacist if you are allergic to mosunetuzumab-axgb, any other medications, or any of the ingredients in mosunetuzumab-axgb injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an infection or if you have or ever have ever had Epstein Barr Virus (EBV; mononucleosis), or low blood cell counts (leukopenia, neutropenia, anemia).
• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with mosunetuzumab-axgb injection. You should use birth control to prevent pregnancy during your treatment with mosunetuzumab-axgb injection and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving mosunetuzumab-axgbinjection, call your doctor. Mosunetuzumab-axgb injection may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 3 months after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving mosunetuzumab-axgb.
• you should know that mosunetuzumab-axgb may make you drowsy and cause confusion, weakness, and dizziness. Do not drive a car or operate machinery after you receive a dose of mosunetuzumab-axgb injection or for the duration of your mosunetuzumab-axgb treatment if you experience any of these symptoms.

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

Mosunetuzumab-axgb may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness, fever, swelling
• rash, itching, dry skin
• headache, tingling in hands or feet, dizziness
• muscle or joint pain
• diarrhea, nausea, abdominal pain

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

• numbness or tingling in arms or legs, dizziness, forgetfulness, sleepiness or insomnia, tremors, loss of consciousness, seizures, loss of balance
• cough, chest pain, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or general unwell feeling
• tender or swollen lymph nodes or pain or swelling a the site of the tumor

Mosunetuzumab-axgb may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Mosunetuzumab-axgb.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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