ASTELLAS PHARMA INDIA PVT.LTD
GENERIC NAME : TACROLIMUS
What is Prograf ?
Prograf (tacrolimus) lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Prograf is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.
Indication and Usage of Prograf
Prograf is a calcineurin-inhibitor immunosuppressant indicated for:
Prophylaxis of organ rejection in patients receiving allogeneicliver, kidney or heart transplants
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil.
Limitations of Use :
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who cannot tolerate capsules orally
Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established.
Dosage and Administration of Prograf
|Patient Population||Recommended Initial Oral Dosage|
(two divided doses every 12 hours)
|Adult Kidney transplant In combination with azathioprine|
In combination with MMF/IL-2 receptor antagonist
|Adult Liver transplant|
Pediatric Liver transplant
|Adult Heart transplant||0.075 mg/kg/day|
Careful and frequent monitoring of tacrolimus trough concentrations is recommended;
Black patients may require higher doses in order to achieve comparable trough concentrations
Hepatic/Renal impaired patients should receive doses at the lowest value of the recommended initial oral dosing range
Administer capsules consistently with or without food; do not drink grapefruit juice
Adverse Reactions of Prograf
Kidney Transplant: The most common adverse reactions ( ≥ 30%) were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, anemia
Liver Transplant: The most common adverse reactions (≥ 40%) were tremor, headache, diarrhea, hypertension, nausea, abnormal renal function, abdominal pain, insomnia, paresthesia, anemia, pain, fever, asthenia, hyperkalemia, hypomagnesemia, and hyperglycemia
Heart Transplant: The most common adverse reactions ( ≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection and hyperlipemia