Idecabtagene vicleucel is an immunotherapy medicine used to treat multiple myeloma in adults. idecabtagene vicleucel is given after at least four other treatments have failed.

Idecabtagene vicleucel is made using white blood cells removed from blood.

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

Idecabtagene vicleucel may also be used for purposes not listed in this medication guide.

A serious side effect of idecabtagene vicleucel 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.

Idecabtagene vicleucel can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

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

Idecabtagene vicleucel 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 idecabtagene vicleucel, a process that will take 4 weeks.

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

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

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

You will be watched closely for at least 7 days after you receive idecabtagene vicleucel, to make sure you do not have an allergic reaction or serious side effects.

You will need frequent blood tests to be sure idecabtagene vicleucel has not caused harmful effects.

Using idecabtagene vicleucel 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.

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

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

Tell your doctor if you have ever had:

• an active infection or inflammation;

• hepatitis B;

• cytomegalovirus; or

• if you have received a vaccine in the past 6 weeks.

Women may need pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with idecabtagene vicleucel and chemotherapy.

If you receive idecabtagene vicleucel during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

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 idecabtagene vicleucel.

In a medical setting an overdose would be treated quickly.

idecabtagene vicleucel 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 idecabtagene vicleucel.

Ask your doctor before you receive a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), polio, 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 idecabtagene vicleucel 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 tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Also call your doctor at once if you have:

• headaches, dizziness, drowsiness;

• problems with thinking or memory;

• trouble speaking or understanding what is said to you;

• tremors, anxiety, sleep problems;

• seizure;

• right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well; 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 idecabtagene vicleucel may include:

• cytokine release syndrome (confusion, 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, severe nausea or diarrhea;

• pain in your bones, joints, or muscles;

• swelling anywhere in your body; or

• cold symptoms such as stuffy nose, sneezing, sore throat, cough.

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 idecabtagene vicleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.