Ivacaftor and tezacaftor and Tisagenlecleucel Intravenous

• Generic Name: ivacaftor / tezacaftor
• Dosage Forms: n.a.
• Other Brand Names: Symdeko, Symdeko 4-Week

Ivacaftor and tezacaftor is a combination medicine used to treat cystic fibrosis in adults and children who are at least 12 years old.

Ivacaftor and tezacaftor is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take ivacaftor and tezacaftor, you may need a medical test to make sure you have this gene mutation.

Ivacaftor and tezacaftor may also be used for purposes not listed in this medication guide.

• 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.