Teclistamab-cqyv 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 teclistamab-cqyv 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.

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

Because of the risk of CRS and central nervous system reactions with this medication, teclistamab-cqyv is only available through a special program called Tecvayli REMS^®. You, your doctor, and your healthcare facility must be enrolled in this program before you can receive teclistamab-cqyv. Ask your doctor for more information about this program.

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

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

Teclistamab-cqyv injection is used to treat multiple myeloma (a type of cancer of the bone marrow) that has returned or has not improved in adults who have received at least 4 other medications. Teclistamab-cqyv is in a class of medications bispecific T-cell engager antibodies. It works by killing cancer cells.

Teclistamab-cqyv comes as a liquid to be injected subcutaneously (under the skin) by a doctor or a nurse in a hospital or medical facility. Initially, it is usually given on days 1, 4, and 7 for the first 3 doses and then once a week thereafter.

Your doctor may delay or stop your treatment with teclistamab-cqyv 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 teclistamab-cqyv injection,

• tell your doctor and pharmacist if you are allergic to teclistamab-cqyv, any other medications, or any of the ingredients in teclistamab-cqyv 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 and infection or if you have or ever have ever had herpes zoster (shingles), low blood cell counts (leukopenia, neutropenia, anemia), or liver problems.
• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with teclistamab-cqyv injection. You should use birth control to prevent pregnancy during your treatment with teclistamab-cqyv injection and for 5 months after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving teclistamab-cqyv injection, call your doctor. Teclistamab-cqyv injection may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 5 months after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving teclistamab-cqyv injection.
• you should know that teclistamab-cqyv may make you drowsy and cause confusion, weakness, and dizziness. Do not drive a car or operate machinery for 48 hours after you recieve a dose of teclistamab-cqyv injection or for the duration of your teclistamab-cqyv treatment if you experience any of these symptoms.

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

If you miss an appointment to receive teclistamab-cqyv injection, call your doctor right away.

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

• redness, heat, swelling, bruising, pain, rash, or blood collection under the skin at the injection site
• nausea
• diarrhea
• constipation
• joint, back, or bone pain
• swelling of the hands, feet, ankles, or lower legs

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:

• recurrent fever
• swollen tongue
• sore throat, cough, fever, chills, or other signs of infection
• extreme tiredness, loss of appetite, pain in upper right side of your stomach, dark urine, or yellowing of the skin or eyes
• unusual bleeding or bruising

Teclistamab-cqyv injection 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).

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving teclistamab-cqyv injection.

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.

• Tecvayli^®