Ciltacabtagene Autoleucel Suspension for Injection

What is this medication?

CILTACABTAGENE AUTOLEUCEL (sil ta kab ta jeen aw toe loo sel) treats multiple myeloma. It is a gene therapy that is made from cells in your immune system.

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

COMMON BRAND NAME(S): CARVYKTI

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

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

• Heart disease
• Infection
• Inflammatory disorder
• Kidney disease
• Liver disease
• Low blood counts
• Lung disease
• Nervous system problems (stroke, seizures, loss of memory)
• An unusual or allergic reaction to ciltacabtagene autoleucel, other medicines, foods, dyes, or preservative
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given in a hospital or clinic setting. This medication 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 care team 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 medication 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 medication.

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

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

This medication may increase your risk of getting an infection. Call your care team 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 medication.

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

Do not become pregnant while taking this medication. 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 care team for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team 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, chills, cough, sore throat, pain or trouble passing urine
• Loss of balance or coordination
• Low blood pressure—dizziness, feeling faint or lightheaded, falls, unusually weak or tired
• Muscle weakness
• Pain, tingling, numbness in the hands or feet
• Seizures
• Sudden numbness or weakness of the face, arm or leg
• Tremors
• Trouble breathing

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

• Diarrhea
• Constipation
• Cough
• Headache
• Joint pain
• Muscle pain
• Nausea

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 medication 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.