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Tacrolimus (Oral, Injection)

Lymphoma risk; infection related to immunosuppression

 Mortality in Liver Transplantation

  • Increased mortality in female transplant recipients was observed in a clinical trial of liver transplantation. Use in liver transplantation is not recommended.

 Increased Susceptibility to Serious Infection, Malignancies

  • Increased susceptibility to infection and the possible development of malignancies, such as lymphoma and skin cancer, may result from immunosuppression. an lead to hospitialization or death; exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.

Qualified Physician/Equipped Facility

  • Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should use tacrolimus.
  • Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
  • The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient .

Not Interchangeable with Extended Release Tacrolimus Products - Medication Errors

  • PROGRAF is not interchangeable or substitutable for tacrolimus extended-release products. Changes between tacrolimus immediate-release and extended- release dosage forms must occur under physician supervision. Instruct patients and caregivers to recognize the appearance of PROGRAF dosage forms and to confirm with the healthcare provider if a different product is dispensed.

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information


Medication Guides

Patient Medication Guide - ASTAGRAF XL
Patient Medication Guide - ENVARSUS XR

Package Inserts


Additional Information

Updated July 2021