Idecabtagene Vicleucel

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Warning

This medication may cause serious (even fatal) reactions (cytokine release syndrome-CRS, hemophagocytic lymphohistiocytosis-HLH/macrophage activation syndrome-MAS). Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms such as high fever, trouble breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness, or signs of kidney problems (such as change in the amount of urine).

Serious nerve problems can occur after treatment with idecabtagene vicleucel. Tell your doctor right away if you have drowsiness, seizure(s), mental/mood changes (such as confusion, anxiety, memory loss), or trouble with reading, writing, speaking, or understanding.

This product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you have signs of infection (such as a sore throat that doesn't go away, fever, chills, cough), easy or unusual bruising/bleeding, or unusual tiredness.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Abecma REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before receiving idecabtagene vicleucel, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, kidney/liver problems, lung or breathing problems, nerve problems (such as memory loss, seizures), past/current/recent infection.

This product can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you drowsy or dizzy, affect your coordination, or make it harder for you to think clearly. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely (at least 8 weeks after receiving treatment is recommended by the manufacturer). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this product. Idecabtagene vicleucel may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product passes into breast milk. Consult your doctor before breast-feeding.

Side Effects

See also Warning section.

Nausea, constipation, headache, tiredness, trouble sleeping, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, muscle/joint pain, swelling.

Although idecabtagene vicleucel is used to treat cancer, it may rarely increase your risk of developing other cancers. Tell your doctor right away if you develop swollen glands or unusual growths/lumps.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Copyright © 2021 TraceGains, Inc. All rights reserved.

RxAnswers™ is a copyrighted combined product from TraceGains and First DataBank, Inc.

Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

This information is intended only for residents of the United States. Products sold under the same brand names in other countries may contain different ingredients.

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TraceGains and/or its suppliers make no warranties or representations as to the accuracy or completeness of this content herein or that of any organization referred or linked to within this content and will not be liable for any damages arising out of your access to or use of any information found herein or that of any organization referred to within this content.

Information expires December 2021.

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