Ciltacabtagene autoleucel is an immunotherapy medicine used to treat multiple myeloma in adults. ciltacabtagene autoleucel is given after at least four other treatments have failed.

Ciltacabtagene autoleucel is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Ciltacabtagene autoleucel may also be used for purposes not listed in this medication guide.

A serious side effect of ciltacabtagene autoleucel is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Ciltacabtagene autoleucel is available only at an authorized hospital or clinic, and must be given by specially trained healthcare professionals.

Ciltacabtagene autoleucel is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis).

During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood. The cells are then sent to a laboratory where they are made into ciltacabtagene autoleucel, a process that will take 4 to 5 weeks.

About 3 days before ciltacabtagene autoleucel is given, you will be pre-treated with chemotherapy to help prepare your body for ciltacabtagene autoleucel.

Just before you receive ciltacabtagene autoleucel, you will be given other medications to help prevent serious side effects or allergic reaction.

Once your body is ready to receive ciltacabtagene autoleucel, your care providers will inject the medicine into a vein through an IV.

You will be watched closely after you receive ciltacabtagene autoleucel, to make sure you do not have an allergic reaction or serious side effects.

You will need frequent blood tests to be sure ciltacabtagene autoleucel has not caused harmful effects.

Using ciltacabtagene autoleucel may increase your risk of developing other cancers. Ask your doctor about this risk. You may need cancer screening tests for the rest of your life.

Ciltacabtagene autoleucel may cause false results on a laboratory test for human immunodeficiency virus (HIV). Tell any doctor who treats you that you are using ciltacabtagene autoleucel.

For at least 4 weeks, plan to stay near the hospital or clinic where you received ciltacabtagene autoleucel. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.

Usual Adult Dose for Multiple Myeloma:

Provided as one bag with a single dose for IV infusion:
Recommended dose range: 0.5 to 1.0 × 10(6) CAR-positive viable T cells per kg of body weight
Maximum dose of 1×10(8) CAR-positive viable T cells per single infusion
Treatment duration: The single IV infusion should be administered within 2.5 hours

Comments:
-This drug is for autologous use only. The patient identity must match the identifiers on the drug cassette and infusion bag. Do not use if the information on the patient-specific labels does not match.

Use: For the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD 38 monoclonal antibody.

Tell your doctor if you have ever had:

• neurologic problems (such as stroke, seizures, memory loss);

• breathing problems;

• heart problems;

• liver or kidney disease;

• recent or active infection; or

• low blood counts.

Women will need pregnancy testing before receiving this medicine. You also will need to use birth control to prevent pregnancy during treatment with ciltacabtagene autoleucel. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent side effects of ciltacabtagene autoleucel.

In a medical setting an overdose would be treated quickly.

ciltacabtagene autoleucel can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with ciltacabtagene autoleucel.

Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Do not donate blood, an organ, or any tissues or cells.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of ciltacabtagene autoleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also call your doctor at once if you have:

• confusion, loss of consciousness, seizures, problems with speech, reading or writing, depression;

• tingling and numbness of hands and feet , leg and arm weakness, facial numbness; or

• low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of ciltacabtagene autoleucel may include:

• confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;

• headache, dizziness;

• problems with speech;

• low blood cell counts;

• fever, chills, tiredness, or other signs of infection;

• decreased appetite, constipation, nausea or diarrhea; or

• pain in your joints or muscles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect ciltacabtagene autoleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.