Warnings:

This medication may cause serious (even fatal) reactions (cytokine release syndrome-CRS, hemophagocytic lymphohistiocytosis-HLH/macrophage activation syndrome-MAS). Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms such as high fever, trouble breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness, or signs of kidney problems (such as change in the amount of urine).

Serious nerve problems can occur after treatment with idecabtagene vicleucel. Tell your doctor right away if you have drowsiness, seizure(s), mental/mood changes (such as confusion, anxiety, memory loss), or trouble with reading, writing, speaking, or understanding.

This product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you have signs of infection (such as a sore throat that doesn't go away, fever, chills, cough), easy or unusual bruising/bleeding, or unusual tiredness.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Abecma REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Warnings:

This medication may cause serious (even fatal) reactions (cytokine release syndrome-CRS, hemophagocytic lymphohistiocytosis-HLH/macrophage activation syndrome-MAS). Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms such as high fever, trouble breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness, or signs of kidney problems (such as change in the amount of urine).

Serious nerve problems can occur after treatment with idecabtagene vicleucel. Tell your doctor right away if you have drowsiness, seizure(s), mental/mood changes (such as confusion, anxiety, memory loss), or trouble with reading, writing, speaking, or understanding.

This product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you have signs of infection (such as a sore throat that doesn't go away, fever, chills, cough), easy or unusual bruising/bleeding, or unusual tiredness.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Abecma REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

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Uses

Idecabtagene vicleucel is used to treat a certain type of cancer (multiple myeloma) that has not gotten better or that has come back after other kinds of treatment. This type of treatment is known as gene therapy. Idecabtagene vicleucel is made from your own white blood cells and is given only to you. The white blood cells have been changed to have a specific protein (chimeric antigen receptor-CAR) that helps your body slow or stop the growth of certain cancer cells.

How to use

Read the Medication Guide provided by your health care professional before you start using this product. If you have any questions, ask your health care professionals.

Your doctor will give you 3 days of chemotherapy before treatment with this product to prepare your body.

This product is given by slow injection into a vein as directed by your doctor. You will receive one or more injections, one right after another. Each injection is given over about 30 minutes. To decrease the risk of side effects, your doctor may also give you other medications (such as acetaminophen, diphenhydramine) before injecting idecabtagene vicleucel.

Your doctor will check you daily for at least 7 days after your treatment to see how well it works and help you manage any side effects. You should plan to stay for at least 4 weeks near the place of your treatment (for example, within 2 hours' drive).

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.