Linvoseltamab-gcpt injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). Your doctor may tell you to take certain medications before receiving linvoseltamab-gcpt injection to help prevent this reaction. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, fast heartbeat, or dizziness or lightheadedness.
Linvoseltamab-gcpt injection may also cause serious, life-threatening central nervous system reactions. If you experience any of the following symptoms, tell your doctor immediately: headache; agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations); trouble speaking, writing, thinking, remembering things, paying attention, or understanding things; problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms; numbness and tingling (feeling like "pins and needles"); burning, throbbing, or stabbing pain; changes in your handwriting; and seizures.
You may experience CRS or central nervous system reactions while you receive a dose of linvoseltamab-gcpt but these reactions may occur afterwards. These reactions are more common with the first 2 doses of linvoseltamab-gcpt but may occur at any time during treatment. A doctor or nurse will monitor you carefully during your infusion and you will be hospitalized to monitor your condition for at least 24 hours after your first 2 infusions. Your healthcare provider will give you a Patient Wallet Card with a list of symptoms. If any of these symptoms occur, you should get medical help right away. Carry the card with you at all times during your treatment with linvoseltamab-gcpt injection, and show it to all of your healthcare providers.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to linvoseltamab-gcpt.
You will be given the Medication Guide when you begin treatment with linvoseltamab-gcpt. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
Talk to your doctor about the risk(s) of receiving linvoseltamab-gcpt.
Why is this medicine prescribed?
Linvoseltamab-gcpt is used for the treatment of multiple myeloma (a type of cancer of the bone marrow). Linvoseltamab-gcpt is in a class of medications called bispecific T-cell receptor engager antibodies. It works by stimulating the immune system to kill cancer cells.
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?
Linvoseltamab-gcpt comes as a solution (liquid) to be given intravenously (into a vein) by a medical professional in a hospital or medical facility. Your doctor will tell you how often you will receive linvoseltamab-gcpt. The schedule depends on your condition and on how your body responds to the medication. The length of treatment depends on how you respond to the medication.
Your doctor may delay or stop your treatment with linvoseltamab-gcpt 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.
What special precautions should I follow?
Before receiving linvoseltamab-gcpt,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving linvoseltamab-gcpt. 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 have or have ever had 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 linvoseltamab-gcpt injection. You should use birth control to prevent pregnancy during your treatment with linvoseltamab-gcpt 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 linvoseltamab-gcpt injection, call your doctor. linvoseltamab-gcpt 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 linvoseltamab-gcpt may make you drowsy and cause confusion, weakness, and dizziness. Do not drive a car, operate heavy machinery, or do other dangerous activities for 48 hours after you receive a dose of linvoseltamab-gcpt injection or for the duration of your linvoseltamab-gcpt treatment if you experience any of these symptoms.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving linvoseltamab-gcpt.
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 linvoseltamab-gcpt injection, call your doctor right away.
What side effects can this medicine cause?
Linvoseltamab-gcpt may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- joint or muscle pain
- nausea, diarrhea
- headache
- shortness of breath
- tiredness, weakness
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:
- extreme tiredness; loss of appetite; pain in upper right side of your stomach, dark urine, or yellowing of the skin or eyes
- sore throat, cough, fever, chills, or other signs of infection
Linvoseltamab-gcpt 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?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving linvoseltamab-gcpt.
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.