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Afamitresgene autoleucel may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusion, during your stay at the healthcare facility (at least 7 days), and for at least 4 weeks after your treatment. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to afamitresgene autoleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills/shivering, difficulty breathing, fast or irregular heartbeat, dizziness or lightheadedness, tiredness, nausea, vomiting, or diarrhea, headache, or rash.
Afamitresgene autoleucel is only available through a special restricted distribution program because of the risks of CRS. You can only receive the medication from a doctor and healthcare facility that participates in the program. Ask your doctor if you have any questions about this program.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with afamitresgene autoleucel. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risk(s) of receiving afamitresgene autoleucel.
WHY is this medicine prescribed?
Afamitresgene autoleucel is used in adults to treat certain types of synovial sarcoma that cannot be treated with surgery or is unresponsive to other treatments. Afamitresgene autoleucel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
HOW should this medicine be used?
Afamitresgene autoleucel comes as a suspension (liquid) to be given intravenously (into a vein) by a doctor or nurse in a hospital. It is usually given in an hour or less as a one-time dose. Before you receive your afamitresgene autoleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for afamitresgene autoleucel.
Before your dose of afamitresgene autoleucel injection is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). Because this medication is made from your own cells, it must be given only to you. It is important to be on time and to not to miss your scheduled cell collection appointment(s) or to receive your treatment dose. Your healthcare provider will check you daily for at least 7 days after you receive your afamitresgene autoleucel dose to monitor you for any side effects. You should also plan to stay near where you received your afamitresgene autoleucel treatment for at least 4 weeks after your dose. Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.
Are there OTHER USES for this medication?
Afamitresgene autoleucel is also sometimes used to treat other conditions. Talk to your doctor about the risks of using this medication for your condition.
What SPECIAL PRECAUTIONS should I follow?
Before taking afamitresgene autoleucel,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you miss the appointment to collect your cells, you must call your doctor and the collection center right away. If you miss the appointment to receive your afamitresgene autoleucel dose, you must call your doctor right away.
What SIDE EFFECTS can this medicine cause?
Afamitresgene autoleucel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
Afamitresgene autoleucel may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication.
Afamitresgene autoleucel may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What OTHER INFORMATION should I know?
Keep all appointments with your doctor, the cell collection center, and the laboratory. Your doctor may order certain lab tests before, during, and after your treatment to check your body's response to afamitresgene autoleucel injection.
Ask your pharmacist any questions you have about afamitresgene autoleucel injection.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 20, 2024.