Tacrolimus - Side Effects

What is tacrolimus?


Tacrolimus (also known as FK506) is an immunosuppressive drug. It inhibits the formation of T-cells, the activation of lymphocytes and the production of cytokines. It inhibits calcineurin. The drug is placed on the market in various forms.
  • In organ transplants

Capsules containing 0.5 mg 1 mg or 5 mg of tacrolimus, which have to be administered 2 times per day. A new variant (April 2007), Advagraf, need to be swallowed only 1 time per day.
  • In dermatology

The ointment is available in two concentrations: 0.03% and 0.1%, wherein the first is intended for children.

Application

In organ transplantation, it is used as an alternative to cyclosporine. Tacrolimus causes less high blood pressure, increased cholesterol and gum problems. On the other hand it causes relatively more often diabetes and diarrhea.
In dermatology it is only registered for use in atopic eczema, but it is also in other skin conditions sometimes tried as an alternative to dermatocorticosteroiden.

Tacrolimus


Tacrolimus side effects


When used in the dermatology
Ointment: burning or itching after application, these symptoms decrease as the eczema becomes less. Initially, they took account of increased susceptibility to infections. However, studies show that the risk of infection does not increase.

The FDA and EMA (agencies dealing with drug safety) have issued a security alert regarding a possible increased risk of developing cancer:
  • In theory tacrolimus may promote carcinogenesis
  • Meanwhile, in 19 cases the use of tacrolimus has been associated with cancer. Compared to more than 5.4 million prescriptions.
Dutch Pharmacovigilance Centre concludes that doctors and pharmacists will have to inform these potential risks. Judgments about the cancer risk one does not. However, recent research this increased risk is not apparent.

In organ
  • damage of the kidneys
  • increase of the cholesterol
  • increase in blood pressure
  • diarrhea
  • infections

Immunosuppressive drugs, such as tacrolimus increase the risk of developing cancer. This particularly comes to skin cancer and lymphoma.

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