Prograf (tacrolimus) is an approved immunosuppressant that, used together with other medicines, helps to prevent rejection after an organ transplant (heart, liver or kidneys).

Scientific evidence suggests that tacrolimus may help to manage symptoms of myasthenia gravis, a rare autoimmune disease in which the body produces antibodies that disrupt communication between nerves and muscles.

How Prograf (tacrolimus) works

Because myasthenia gravis is caused by an autoimmune response — immune attacks targeting normal and healthy tissue — suppressing immune system activity may improve disease symptoms.

Besides its immunosuppressive effect, researchers think tacrolimus may improve communication between nerve cells and muscle cells by increasing the release of calcium ions in muscle cells. Calcium interacts with two proteins found inside cells, called actin and myosin, leading to better muscle contraction.

Clinical trials

Several studies assessed the potential benefits of tacrolimus in the management of myasthenia gravis. The largest randomized and controlled study among these — a Phase 3 double-blind, placebo-controlled study (NCT00309088) — showed treatment was well-tolerated with no safety concerns, but effectiveness was not evident. The trial, which ended in 2008, failed to meet its primary goal, and no significant differences were found between drug and placebo treatments.

A single center, retrospective study of low-dose tacrolimus in myasthenia gravis patients concluded that treatment may be of benefit after unsuccessful thymectomy (surgical removal of the thymus) and conventional immunosuppressant use, as well as in people unable to undergo a thymectomy. Tacrolimus was especially useful when given after thymectomy in combination with prednisone. In the majority of participants, it replaced prednisone as an immunosuppressive agent.

Additional studies are needed to confirm its potential benefits to myasthenia gravis patients.

Other details

Because Prograf (tacrolimus) suppresses the immune system, it increases the risk of serious infections and cancer.

Common side effects of Prograf use include infections, high blood pressure, high or low potassium blood levels, tremors or shaking, numbness or tingling, nausea, diarrhea or constipation, headache, general pain and difficulty sleeping.

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