TACROLIMUS

generic for PROGRAF

Tacrolimus Warnings

Patients have benefited from tacrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using tacrolimus. It is not known whether tacrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor right away.

The US Food and Drug Administration recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Tacrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used in children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.
  • Avoid prolonged or excessive exposure to direct and/or artificial sunlight while using this medication.
  • For external use only.
  • Read the boxed warning information for this medication.

Lactation Warnings

  • MINIMAL SYSTEMIC ABSORPTION EXPECTED

Pregnancy Warnings

  • Insufficient human and animal data with topical form; minimally absorbed
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