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Tacrolimus and Nephrotic Syndrome

Is Tacrolimus Used to Treat Nephrotic Syndrome?

Tacrolimus (Prograf®, Protopic®) is an immunosuppressant medication approved to prevent transplant rejection in people who have received a kidney, heart, or liver transplant. It is also an active ingredient in an ointment that is applied to the skin to treat symptoms of atopic dermatitis (commonly called eczema). This medicine is sometimes used off-label to treat nephrotic syndrome.
The phrase "off-label" refers to using a drug in a way that has not been officially approved by the U.S. Food and Drug Administration (FDA). It is also sometimes called an "unapproved" or "nonapproved" use. Off-label use is legal, and many medicines are used appropriately and safely for off-label purposes.
Because tacrolimus can cause potentially serious side effects, it is typically reserved for people who have failed other treatments, such as corticosteroids.

Is Tacrolimus Effective for This Use?

Tacrolimus has been studied in clinical trials for the treatment of nephrotic syndrome in children and adults. In these studies, tacrolimus was more effective than a placebo (a "sugar pill" that does not contain any active ingredients) in adults and as effective as cyclosporine (Gengraf®, Neoral®, Sandimmune®), another immunosuppressant medication, in children.
In one study, 82 percent of adults who were using tacrolimus were considered to be in remission (with little or no symptoms) after 12 months of treatment, compared with 24 percent of people taking the placebo. In another study, 86 percent of children given tacrolimus went into remission, compared with 80 percent of those given cyclosporine. In addition, children who were using tacrolimus were less likely to experience a return of their symptoms (called a relapse).

Tacrolimus Drug Information

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