Tisagenlecleucel (Intravenous)
Medically reviewed by Drugs.com. Last updated on Jun 8, 2022.
Warning: Cytokine release syndrome and neurological toxicitiesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving tisagenlecleucel. Do not administer tisagenlecleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurological toxicities, which may be severe or life-threatening, can occur following treatment with tisagenlecleucel, including concurrently with CRS. Monitor for neurological events after treatment with tisagenlecleucel. Provide supportive care as needed.Tisagenlecleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS .
Commonly used brand name(s)
In the U.S.
- Kymriah
Available Dosage Forms:
- Suspension
Therapeutic Class: Antineoplastic Agent
Chemical Class: CAR T-Cell Agent
Uses for tisagenlecleucel
Tisagenlecleucel injection is used to treat B-cell acute lymphoblastic leukemia (ALL) that has come back a second or later time or after other medicines did not work well in patients up to 25 years of age. Leukemia is a type of cancer where the body makes abnormal white blood cells.
Tisagenlecleucel injection is also used to treat diffuse large B-cell lymphoma (DLBCL) that has come back a second or later time or after at least 2 other medicines did not work well. Lymphoma is a type of cancer where the body makes abnormal white blood cells.
Tisagenlecleucel injection is an antineoplastic (cancer) medicine that is made from your own white blood cells. These cells are reprogrammed to contain a chimeric antigen receptor (CAR) to identify the cancer cells from the normal cells and kill them. Before you begin treatment, talk to your doctor about the benefits of tisagenlecleucel as well as the possible risks of receiving it.
Tisagenlecleucel is available only under a restricted distribution program called Kymriah® REMS (Risk Evaluation and Mitigation Strategy) Program.
Before using tisagenlecleucel
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tisagenlecleucel, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to tisagenlecleucel or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tisagenlecleucel injection in children with ALL. Safety and efficacy have been established.
Appropriate studies have not been performed on the relationship of age to the effects of tisagenlecleucel injection in children with DLBCL. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of tisagenlecle..
