CARVYKTI- ciltacabtagene autoleucel injection, suspension
Janssen Biotech, Inc
CARVYKTI ® (car-vick-tee)
|Manufactured/Marketed by: Janssen Biotech, Inc., Horsham, PA 19044, USA. U.S. License Number 1864|
|Marketed by: Legend Biotech, Somerset, NJ 08873, USA. For more information, call 1-800-526-7736 or go to www.CARVYKTI.com.|
|Read this Medication Guide before you start your CARVYKTI treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment.|
|What is the most important information I should know about CARVYKTI?
CARVYKTI may cause side effects that are severe or life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:
|What is CARVYKTI?
|Before you receive CARVYKTI tell your healthcare provider about all your medical conditions, including if you have:
|How will I receive CARVYKTI?
30 to 60 minutes before you are given CARVYKTI, you may be given other medicines. These may include:
After getting CARVYKTI, you will be monitored at the certified healthcare facility where you received your treatment for at least 10 days after the infusion.
You should plan to stay close to the location where you received your treatment for at least 4 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital.
Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
|What should I avoid after receiving CARVYKTI?
|What are the possible or reasonably likely side effects of CARVYKTI?
The most common side effects of CARVYKTI include:
CARVYKTI can increase the risk of life-threatening infections including COVID 19 that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.
CARVYKTI can cause various neurologic side effects, some of which may be severe or fatal. Symptoms include but are not limited to confusion, disorientation, loss of consciousness, seizures, difficulty speaking, reading or writing, tremor, slower movements, changes in personality, depression, tingling and numbness of hands and feet, leg and arm weakness, and facial numbness.
CARVYKTI can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]), which may make you feel weak or tired or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.
Having CARVYKTI in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.
These are not all the possible side effects of CARVYKTI. Call your healthcare provider if you have any side effects.
You may report side effects to FDA at 1-800-FDA-1088.
|General information about the safe and effective use of CARVYKTI
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about CARVYKTI, talk with your healthcare provider. You can ask your healthcare provider for information about CARVYKTI that is written for health professionals. For more information go to www.CARVYKTI.com or call 1-800-526-7736.
|What are the ingredients in CARVYKTI?
Active ingredient: ciltacabtagene autoleucel
Inactive ingredients: DMSO
This Medication guide has been approved by the U.S. Food and Drug Administration.
Revised: FEB 2023