Tacrolimus Intravenous and Tisagenlecleucel Intravenous

• Generic Name: tacrolimus
• Dosage Forms: n.a.
• Other Brand Names: Astagraf XL, Envarsus XR, Prograf, Hecoria

Tacrolimus injection is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). Tacrolimus may be used with steroids, azathioprine, or mycophenolate mofetil. Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of tacrolimus as well as the risks of using it.

Tacrolimus is to be given only by or under the direct supervision of a doctor.

• Generic Name: tisagenlecleucel
• Dosage Forms: n.a.
• Other Brand Names: Kymriah

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.