Cytokine release syndrome, a potentially fatal reaction to iltacabtagene autoleucel injection, is a possible side effect. After your infusion and for at least 10 days following, a doctor or nurse will keep a close eye on you. If you have an inflammatory illness or believe you may have an infection of any kind right now, let your doctor know. To lessen the chance of adverse responses to ciltacabtagene autoleucel, medicines will be administered to you 30 to 60 minutes prior to the infusion. Any of the following symptoms, both during and after your infusion, should be reported to your doctor right away: fever, chills, headache, fast or irregular heartbeat, muscle pain, shaking, diarrhea, exhaustion, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

Injection of ciltacabtagene autoleucel may result in severe, deadly, or life-threatening responses of the central nervous system. After receiving ciltacabtagene autoleucel therapy, these responses may manifest days, weeks, or months later. Inform your doctor if you experience or have ever experienced memory loss, seizures, or strokes. Dizziness, trouble falling or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, difficulty writing, agitation, seizures, slow movement, change in personality or loss of interest in usual activities, loss of coordination or balance, weakness, difficulty speaking, or numbness in the face are all symptoms that should be reported to your doctor right away.

The amount of specific blood cell types in your blood may significantly drop as a result of receiving a ciltacabtagene autoleucel injection. This could result in specific symptoms and raise your risk of getting a major infection or bleeding. If you have an infection now or recently, let your doctor know. Tell your doctor right once if you suffer any of the following symptoms following treatment: fatigue; bruises; bleeding; fever, chills, or other infection-related symptoms.

The only way to obtain iltacabtagene autoleucel injection is through a unique, restricted distribution program. The hazards associated with CRS, issues with the central nervous system, and blood cell issues have led to the establishment of the Carvykti REMS program (Risk Evaluation and Mitigation Strategy). Only medical professionals and healthcare facilities that take part in the program may provide you drugs. If you have any inquiries regarding this program, speak with your doctor.

When you start receiving ciltacabtagene autoleucel medication and each time your prescription is renewed, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Adults with multiple myeloma (a bone marrow cancer type) that has returned or did not respond to at least four prior treatments are treated with ciltacabtagene autoleucel. The drug ciltacabtagene autoleucel belongs to a family of treatments known as autologous cellular immunotherapy, which is a treatment made with the patient’s own blood cells. It functions by activating the body’s immune system, a collection of cells, tissues, and organs that defends the body against attacks from bacteria, viruses, cancer cells, and other pathogens.

In a hospital or infusion facility, a doctor or nurse will inject iltacabtagene autoleucel intravenously (into a vein) using a suspension form of the drug. A single dose is typically administered over a period of 30 to 60 minutes. Your doctor or nurse will give you other chemotherapy drugs to take before you receive your ciltacabtagene autoleucel dose to get your body ready for it.

A cell collection facility will use a process known as leukapheresis to collect a sample of your white blood cells prior to administering your dosage of ciltacabtagene autoleucel injection. This drug must only be administered to you because it is created from your own cells. Being on time is crucial in order to avoid missing your scheduled cell collection appointment(s) or your treatment dose. When you receive your ciltacabtagene autoleucel dose, your healthcare practitioner will check you every day for at least 10 days to look for any side effects. For at least 4 weeks following your dose, you should also plan to stay close to the location where you received your ciltacabtagene autoleucel treatment. Your healthcare practitioner will check to see if your medication is having the desired effect and keep an eye out for any potential adverse effects. Discuss with your doctor how to be ready for leukapheresis as well as what to expect both during and after the treatment.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving ciltacabtagene autoleucel,

• If you have an allergy to ciltacabtagene autoleucel, any other drugs, dimethyl sulfoxide (DMSO), or any of the substances in ciltacabtagene autoleucel injection, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you have or have ever had hepatitis B or C (HBV or HCV; viruses that infect the liver and may cause severe liver damage), other viruses like cytomegalovirus or human immunodeficiency virus (HIV), breathing or lung issues, kidney, heart, or liver disease, or lung or breathing problems. Cytomegalovirus is a common virus that typically only causes serious symptoms in people who have weakened immune systems or who are infected at birth.
• Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. A pregnancy test is required before beginning ciltacabtagene autoleucel. While undergoing ciltacabtagene autoleucel, you should not become pregnant on your own or with your partner. Call your doctor right away if you get pregnant while taking ciltacabtagene autoleucel. The fetus can suffer from iltacabtagene autoleucel.
• You should be aware that ciltacabtagene autoleucel injection may cause you to feel sleepy, confused, weak, dizzy, experience seizures, and have trouble with your coordination. For at least 8 weeks after receiving your ciltacabtagene autoleucel dosage, avoid operating machinery or operating a vehicle.
• After receiving your ciltacabtagene autoleucel injection, refrain from giving blood, organs, tissues, or cells for transplantation.
• Find out from your doctor if you require any vaccines. For at least 6 weeks prior to beginning chemotherapy, throughout your treatment with ciltacabtagene autoleucel, and until your doctor notifies you that your immune system has healed, refrain from getting any vaccinations without first consulting a medical professional.

Keep eating normally unless your doctor instructs you otherwise.

You must contact your doctor and the collection center right once if you fail to keep the appointment to collect your cells. Call your doctor as soon as possible if you don’t show up for your scheduled ciltacabtagene autoleucel dose.

Side effects from iltacabtagene autoleucel are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Diarrhea
• Reduced appetite
• Pain in a bone, muscle, or joint
• Swelling
• Constipation

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if any of these symptoms or any of the symptoms listed in the IMPORTANT CAUTION section appear to you:

• Chest pain, a fast heartbeat, a rash, itching, hives, swelling of the face, mouth, tongue, or throat, or trouble breathing or swallowing

The chance of developing some malignancies may increase if you use iltacabtagene autoleucel. You should discuss the dangers of using this drug with your doctor.

Further adverse effects of iltacabtagene autoleucel are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone if you have a serious side event.

Keep any appointments you have with your physician, the cell collection facility, and the lab. Before, during, and after your therapy, your doctor might request certain lab tests to see how your body is responding to the ciltacabtagene autoleucel injection.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Also, it is crucial to have this knowledge on hand in case of emergency.