Tacrolimus(alsoFK-506orfujimycin, trade namesPrograf,Advagraf,Protopic) is animmunosuppressive drugused mainly afterallogeneic organ transplantto lower the risk of organrejection. It achieves this by inhibiting the production ofinterleukin-2, amoleculethat promotes the development andproliferationoft cells, which are vital to the body's learned (oradaptive) immune response. Tacrolimus is also used in the treatment of other T cell-mediated diseases such aseczema(for which it is applied to the skin in a medicated ointment), severe refractoryuveitisafterbone marrowtransplants, exacerbations ofminimal change disease,Kimura's disease, and the skin conditionvitiligo.

Prograf is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose monohydrate NF, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 0.5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains gelatin NF, titanium dioxide USP and ferric oxide NF.

Prograf is also available as a sterile solution (tacrolimus injection) containing the equivalent of 5 mg anhydrous tacrolimus USP in 1 mL for administration by intravenous infusion only. Each mL contains polyoxyl 60 hydrogenated castor oil (HCO-60), 200 mg, and dehydrated alcohol, USP, 80.0% v/v. Prograf injection must be diluted with 0.9% Sodium Chloride Injection or 5% DextroseInjection before use.