Talquetamab-tgvs 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 talquetamab-tgvs 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.

Talquetamab-tgvs 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 talquetamab-tgvs injection, but these reactions may occur afterwards. These reactions are more common with the first 3 doses of talquetamab-tgvs 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 talquetamab-tgvs injection to be sure you are not having a serious reaction to the medication.

Because of the risks of CRS and ICANS, talquetamab-tgvs is only available through a restricted program called the TECVAYLI and TALVEY REMS. Your doctor will register you in the program. Talquetamab-tgvs is only available at certain pharmacies that are registered with TECVAYLI and TALVEY 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 talquetamab-tgvs injection.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with talquetamab-tgvs 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 talquetamab-tgvs injection.

Talquetamab-tgvs 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.

Talquetamab-tgvs 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 7 then weekly thereafter or on days 1, 4, 7 and 10 and then every 2 weeks thereafter. Your doctor will probably start you on a low dose of talquetamab-tgvs and then gradually increase your dose to make sure you tolerate the medication.

Your doctor may delay or stop your treatment with talquetamab-tgvs 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 talquetamab-tgvs,

• tell your doctor and pharmacist if you are allergic to talquetamab-tgvs, any other medications, or any of the ingredients in talquetamab-tgvs 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 talquetamab-tgvs injection. You should use birth control to prevent pregnancy during your treatment with talquetamab-tgvs 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 talquetamab-tgvs injection, call your doctor. Talquetamab-tgvs 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.
• you should know that talquetamab-tgvs 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.

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

• fever
• fatigue
• chills
• pain
• swelling
• nausea
• constipation or diarrhea
• nail discoloration
• dry skin
• muscle and bone pain
• decreased appetite

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
• dry mouth, difficulty swallowing, altered or loss of taste, or sores in the mouth
• rash or redness of skin, dry skin or itching
• feeling of racing heart
• yellowing of skin or whites of eyes, dark urine or lower abdominal pain

Talquetamab-tgvs may cause weight loss. Talk to your doctor about the risks of taking this medication.

Talquetamab-tgvs 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.

• Talvey^®