他克莫司胶囊说明书(英文)

Patient Population
Recommended Initial
Oral Dosage (two divided doses every 12 hours)
Observed Whole Blood Trough Concentrations
Adult Kidney transplant
In combination with 0.2 mg/kg/day azathioprine
PROGRAF® (tacrolimus) capsules PROGRAF® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete box warning
Prograf is a calcineurin-inhibitor immunosuppressant indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (1.1, 1.2, 1.3)
Careful and frequent monitoring of tacrolimus trough concentrations is recommended; Black patients may require higher doses in order to achieve comparable trough concentrations (2.1)
Limitations of Use (1.4):
o Do not use simultaneously with cyclosporine
o Intravenous use reserved for patients who can not tolerate capsules orally
o Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established
Increased risk of development of lymphoma and other
malignancies, particularly of the skin, due to
immunosuppression (5.2)
Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections (5.3, 5.4, 5.5)
----------------------DOSAGE AND ADMINISTRATION-----------------------
Summary of Initial Oral Dosage Recommendation and Observed Whole Blood Trough Concentrations (2.1, 2.2).
Only physicians experienced in immunosuppressive
therapy and management of organ transplant patients
should prescribe Prograf (5.1)
----------------------------INDICATIONS AND USAGE---------------------------
0.1 mg/kg/day
0.10-0.15 mg/kg/day 0.15-0.20 mg/kg/day 0.075 mg/kg/day
month 1-12: 4-11 ng/mL
month 1-12: 5-20 ng/mL month 1-12: 5-20 ng/mL
month 1-3: 10-20 ng/mwk.baidu.com month ≥4: 5-15 ng/mL
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (1.1, 1.2, 1.3)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF.
month 1-3: 7-20 ng/mL month 4-12: 5-15 ng/mL
In combination with MMF/IL-2 receptor antagonist Adult Liver transplant Pediatric Liver transplant Adult Heart transplant
Hepatic/Renal impaired patients should receive doses at the lowest value of the recommended initial oral dosing range (2.3, 2.4)