Idecabtagene Vicleucel Suspension for Infusion

What is this medication?

IDECABTAGENE VICLEUCEL (eye de kab ta jeen vik loo sel) is a gene therapy that is made from cells in your immune system. It treats multiple myeloma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ABECMA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection
• inflammatory disease
• an unusual or allergic reaction to idecabtagene vicleucel, other medicines, foods, dyes, or preservative
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is infused into a vein. It is given by a health care provider in a hospital or clinic setting. This medicine is made from your own immune cells.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine is not for regular use.

What may interact with this medication?

• live vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

You may need blood work done while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not give blood while taking this medicine.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• confusion
• fast, irregular heartbeat
• infection (fever, or chills, cough, sore throat, pain or trouble passing urine)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• seizures
• severe nausea, vomiting, or diarrhea
• tremors
• trouble breathing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• bone pain
• constipation
• cough
• decreased appetite
• headache
• muscle pain
• swelling of the ankles, feet, hands or other unusual swelling

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.