July 16, 2021

The U.S. FDA has approved an expanded indication for Prograf® (tacrolimus – Astellas Pharma), a drug indicated for use with other immunosuppressants to prevent organ rejection in patients who receive certain types of transplants. Prograf is now approved for patients who undergo lung transplants, in addition to previously approved use in patients receiving liver, kidney, or heart transplants.

Organ transplants are lifesaving procedures but carry a risk of the body rejecting the new organ as foreign material. Immunosuppressants are used to reduce immune system activity, helping to prevent the body from attacking and damaging the new organ. Prograf is now the first FDA-approved drug to prevent organ rejection in adult and pediatric patients receiving a lung transplant. However, its active pharmaceutical ingredient, tacrolimus, has been used off-label for this purpose as a standard of care for many years.

In an observational study of real-world effectiveness, Prograf delivered a dramatic improvement in outcomes for patients receiving a lung transplant when compared to the natural history of using no or minimal immunosuppressive therapy. The FDA also considered results from controlled clinical trials of Prograf in other solid organ transplant settings to confirm effectiveness of the drug.

Recommended dosing is based on the type of transplant received and other individual patient factors such as the patient’s age, weight, and treatment response. The product can be administered as an intravenous infusion or be taken by mouth in either capsule or oral granule form. It should only be used under the supervision of a physician experienced in immunosuppressive therapy. A black box warning cautions that immunosuppressants like Prograf are associated with a risk of malignancies and serious infection that could lead to hospitalization or death.

Prograf first received FDA approval in 1994.

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