ABECMA- idecabtagene vicleucel suspension
|This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: MAR 2021
|Read this Medication Guide before you start your ABECMA 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 ABECMA?
ABECMA may cause side effects that are 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 ABECMA?
ABECMA is for the treatment of multiple myeloma in patients who have received at least four kinds of treatment regimens that have not worked or have stopped working. ABECMA is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.
|How will I receive ABECMA?
ABECMA is made from your own white blood cells, so your blood will be collected by a process called "leukapheresis" (LOO-kuh-feh-REE-sis).
Your blood cells will be sent to a manufacturing center to make your ABECMA. Based on clinical trial experience, it takes about 4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
Before you get ABECMA, your healthcare provider will give you chemotherapy for 3 days to prepare your body.
When your ABECMA is ready, your healthcare provider will give ABECMA to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of ABECMA may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
You will be monitored at the certified healthcare facility where you received your treatment daily for at least 7 days after the infusion.
You should plan to stay within 2 hours of this location for at least 4 weeks after getting ABECMA. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
|What should I avoid after receiving ABECMA?
|What are the possible or reasonably likely side effects of ABECMA?
The most common side effects of ABECMA are:
ABECMA can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.
ABECMA can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired or increase your risk of severe infection or bleeding. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.
Having ABECMA in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests.
These are not all the possible side effects of ABECMA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|General information about the safe and effective use of ABECMA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ABECMA, talk with your healthcare provider. You can ask your healthcare provider for information about ABECMA that is written for health professionals.
For more information, go to ABECMA.com or call 1-888-805-4555.
Manufactured by: Celgene Corporation, a Bristol-Myers Squibb Company, 556 Morris Avenue, Summit, NJ 07901
Marketed by: Celgene Corporation, a Bristol-Myers Squibb Company (Summit, NJ 07901), and bluebird bio, Inc. (Cambridge, MA 02142)
ABECMA® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
ABEMG001 03/2021 © 2021 Celgene Corporation, a Bristol-Myers Squibb Company. All Rights Reserved.