CARVYKTI contains the active ingredient ciltacabtagene autoleucel, which is a BCMA-directed genetically modified autologous T cell immunotherapy. It is formulated as a suspension for infusion, specifically prepared for each patient through a leukapheresis procedure. Key inactive ingredients include dimethyl sulfoxide (DMSO). This therapy is intended to recognize and eliminate cells expressing the BCMA antigen.

How should I use this medication?

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

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 medication 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.

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.

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, hives, swelling of the face, lips, tongue, or throat
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, shuffling walk
• Numbness or weakness of the face, uneven smile
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Severe back pain, numbness or weakness of the hands, arms, legs, or feet, loss of coordination, loss of bowel or bladder control
• Unusual bruising or bleeding

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

• Diarrhea
• Fatigue
• Headache
• Loss of appetite
• 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.

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 medications, foods, dyes, or preservative
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

• Live virus 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 donate blood, organs, tissues, or cells for transplant while you are 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.

Talk to your care team if you may be pregnant. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you.

What are the most serious risks of this medication?

This medication can decrease the amount of blood cells (white cells, red cells, platelets) your body makes. This increases the risk of anemia, bleeding, and infection. Your care team will check your blood cell levels during your treatment. Talk to your care team right away if you have unusual bruising or bleeding, fever, chills, cough, sore throat, pain or trouble when passing urine, or a general feeling of discomfort or being unwell.

This medicine may cause serious side effects that can lead to death if not treated. Symptoms may include low blood pressure (dizziness, feeling faint or lightheaded, falls, or unusually weak or tired), signs of kidney injury (trouble passing urine or change in the amount of urine), trouble breathing, or low blood counts leading to infection or unusual bleeding or bruising. Contact your health care provider right away if you have any of these symptoms.

This medication may increase the risk of blood or bone marrow cancer. Your care team will monitor your blood work closely.

This medication can cause a serious side effect called cytokine release syndrome. Your care team will monitor you closely. Tell your care team right away if you feel faint or lightheaded or have fever, fatigue, loss of appetite, nausea, headache, shortness of breath, or a fast or irregular heartbeat.

This medication may affect the brain and nervous system. Talk to your care team right away if you have confusion, dizziness, tremors, trouble speaking, weakness, or pain, tingling, or numbness in the hands or feet. Some side effects can be severe. Call emergency services if you have seizures or trouble staying awake.