Elranatamab-bcmm injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. Your doctor may tell you to take certain medications before receiving elranatamab-bcmm injection to prevent this reaction. If you experience any of the following symptoms during and after your injection, tell your doctor immediately: fever, chills, fast or irregular heartbeat, difficulty breathing, shortness of breath, cough, confusion, anxiety, restlessness, headache, dizziness, lightheadedness, muscle pain, shaking, diarrhea, nausea, vomiting, tiredness, or weakness.

Elranatamab-bcmm injection may cause severe or life-threatening central nervous system reactions called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache; restlessness; confusion; loss of consciousness; seizures; uncontrollable shaking or jerking of a part of the body; hearing loss; double vision; difficulty speaking or writing; difficulty walking; muscle tightening or spasms; muscle weakness; burning, throbbing, or stabbing pain; or numbness and tingling of the skin.

You may experience CRS or central nervous system reactions while you receive a dose of elranatamab-bcmm injection, but these reactions may occur afterwards. These reactions are more common with the first 3 doses of elranatamab-bcmm injection but may occur at any time during treatment. A doctor or nurse will monitor you carefully in a hospital or medical facility during your injections and for 48 hours after at least your first 3 doses of elranatamab-bcmm injection to be sure you are not having a serious reaction to the medication.

Because of the risks of CRS and ICANS, elranatamab-bcmm is only available through a restricted program called the ELREXFIO REMS. Your doctor will register you in the program. elranatamab-bcmm is only available at certain pharmacies that are registered with ELREXFIO REMS. Ask your doctor or pharmacist if you have any questions about how you can fill your prescription.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to elranatamab-bcmm injection.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with elranatamab-bcmm injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of receiving elranatamab-bcmm injection.

Elranatamab-bcmm is used to treat multiple myeloma (a type of cancer of the bone marrow) that has returned or that did not respond to at least 4 other treatments. Talquetamab-tgvs is in a class of medications called bispecific T-cell engager antibodies. It works by killing cancer cells.

Elranatamab-bcmm comes as a solution (liquid) to be given subcutaneously (under the skin) by a doctor or a nurse at a healthcare facility. It is usually given on days 1, 4 and 8 then weekly thereafter for 24 weeks. For people who have responded to the elranatamab-bcmm therapy, it will be continued every 2 weeks after week 24. Your doctor will probably start you on a low dose of elranatamab-bcmm and then gradually increase your dose to make sure you tolerate the medication.

Your doctor may delay or stop your treatment with elranatamab-bcmm injection, 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 elranatamab-bcmm,

• tell your doctor and pharmacist if you are allergic to elranatamab-bcmm, any other medications, or any of the ingredients in elranatamab-bcmm injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have an infection or if you have or have ever had low blood cell counts (leukopenia, neutropenia, anemia) or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with elranatamab-bcmm injection. You should use birth control to prevent pregnancy during your treatment with elranatamab-bcmm injection and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving elranatamab-bcmm injection, call your doctor. Elranatamab-bcmm injection may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 4 months after your final dose.
• you should know that elranatamab-bcmm may make you dizzy or cause confusion. Do not drive a car or operate machinery until you know how this medication affects you.

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

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

• fatigue or tiredness
• pain, bruising or swelling at the site of injection
• diarrhea or constipation
• nausea and/or vomiting
• muscle or bone pain
• rash or dry and peeling skin
• decreased appetite
• difficulty sleeping

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:

• fever, chills, weakness, cough, shortness of breath, or sore throat
• yellowing of skin or whites of eyes, dark urine or lower abdominal pain

Elranatamab-bcmm 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 (http://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 talquetamab-tgvs. If you miss a scheduled infusion for talquetamab-tgvs, you may have to start over with the first cycle dose.

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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