Injection of idecabtagene vicleucel may result in a severe or fatal event known as cytokine release syndrome (CRS). For at least 4 weeks following your infusion, a doctor or nurse will keep a close eye on you. If you currently have or suspect that you may have an infection of any kind, tell your doctor. In order to lessen the chance of adverse responses to idecabtagene vicleucel, you will get medicine 30 to 60 minutes before to your infusion. Tell your doctor right away if you experience any of these symptoms during or after your infusion: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhoea, exhaustion, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

Injection of idecabtagene vicleucel may result in serious or fatal central nervous system responses. After receiving idecabtagene vicleucel therapy, these responses are possible. Inform your doctor if you experience or have ever experienced memory loss, seizures, or strokes. You should contact your doctor right away if you experience any of the following symptoms: headache, dizziness, trouble falling or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or trouble speaking.

The injection of idecabtagene vicleucel may significantly reduce the amount of specific blood cell types in your blood. This could result in specific symptoms and raise your risk of getting a major infection or bleeding. After receiving treatment, if you suffer any of the following symptoms, call your doctor right away: fever, exhaustion, bruises, or bleeding are all symptoms.

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

When you first start receiving idecabtagene vicleucel therapy and each time you get a prescription refill, 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 specific forms of multiple myeloma (a bone marrow cancer) who have had their illness come back or who have had no response to at least four different treatments can receive the injectable idecabtagene vicleucel. The drug idecabtagene vicleucel injection belongs to a group of treatments known as autologous cellular immunotherapy, which is a treatment made from 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.

Idecabtagene vicleucel injection is administered intravenously (into a vein) by a physician or nurse in a clinic or infusion facility. It comes as a suspension (liquid). It is typically administered as a single dose over a period of up to 30 minutes. Your doctor or nurse will give you other chemotherapy drugs to take before your idecabtagene vicleucel dose in order to get your body ready.

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 idecabtagene vicleucel injection (a process that removes white blood cells from the body). 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. For at least 4 weeks following your dose, you should make arrangements to remain 2 hours from the site where you received your idecabtagene vicleucel treatment. Your healthcare practitioner will assess the effectiveness of your treatment and keep an eye out for any potential adverse effects. Consult your doctor for information on leukapheresis preparation, as well as what to expect both during and after the procedure.

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

Before receiving idecabtagene vicleucel injection,

• If you have an allergy to idecabtagene vicleucel, any other drugs, dimethyl sulfoxide (DMSO), or any of the chemicals in idecabtagene vicleucel injection, tell 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 any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Steroids like dexamethasone, methylprednisolone (Medrol), prednisolone, and prednisone should be mentioned, to name a few (Rayos). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• If you have ever experienced side effects from chemotherapy treatments, such as breathing issues or an erratic heartbeat, let your doctor know. Additionally, let your doctor know whether you now or formerly had liver, renal, heart, or lung issues.
• Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. A pregnancy test is required before beginning idecabtagene vicleucel. Call your doctor right away if you get pregnant while taking idecabtagene vicleucel. The foetus can suffer from idecabtagene vicleucel.
• You should be aware that idecabtagene vicleucel injection may cause you to feel sleepy, confused, weak, dizzy, experience seizures, and have trouble with your coordination. For at least 8 weeks following your idecabtagene vicleucel dose, avoid operating machinery or operating a vehicle.
• After receiving your idecabtagene vicleucel injection, refrain from giving blood, organs, tissues, or cells for transplantation.
• Find out from your doctor if you require any vaccines. Prior to starting chemotherapy, for at least 6 weeks, during your idecabtagene vicleucel treatment, and until your doctor says your immune system has recovered, avoid getting any vaccinations without first consulting a medical professional.

Call your doctor and the collection centre as soon as possible if you are unable to keep the appointment to collect your cells. Call your doctor as soon as possible if you don’t show up for the appointment to receive your idecabtagene vicleucel dose.

There may be adverse effects from idecabtagene vicleucel. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Constipation
• Loss of weight
• Reduced appetite
• Mouth ache
• Dry mouth
• Wet eyes

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

• Decreased frequency or volume of urine
• Swelling of the lower legs, hands, feet, ankles, lips, tongue, throat, arms, or other body parts
• Having trouble swallowing
• Rash
• Hives
• Itching

Your chance of developing some malignancies may increase if you use idecabtagene vicleucel. You should discuss the dangers of using this drug with your doctor.

Other negative effects of idecabtagene vicleucel could also occur. 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 programme online or by phone if you have a serious side event (1-800-332-1088).

Respect all scheduled times with your doctor, the cell collection facility, and the lab. To monitor your body’s reaction to the idecabtagene vicleucel injection, your doctor may request specific lab tests before to, during, and after your therapy.

Inform the lab staff and your doctor that you are receiving idecabtagene vicleucel prior to any laboratory test. The outcomes of some laboratory tests could be impacted by this medicine.

Ask your pharmacist any inquiries you may have regarding the injection of idecabtagene vicleucel.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.