tacrolimus
Drug Details
- Generic Name
- tacrolimus
- Brand Names
- tacrolimus, Tacrolimus
- Application Number
- ANDA206662
- Sponsor
- NORTHSTAR RX LLC
- NDC Codes
- 10
- Dosage Forms
- CAPSULE, POWDER, OINTMENT
- Routes
- ORAL, TOPICAL
- Active Ingredients
- TACROLIMUS
Indications and Usage
1 INDICATIONS AND USAGE Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant Tacrolimus is indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1) ] , liver transplants [see Clinical Studies (14.2)] , or heart transplant [see Clinical Studies (14.3) ] , and pediatric patients receiving allogeneic liver transplants [see Clinical Studies (14.2) ] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.