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
Patient Counseling Information