Prograf

Prograf

tacrolimus

Manufacturer:

Astellas

Distributor:

Zuellig
Concise Prescribing Info
Contents
Tacrolimus
Indications/Uses
Prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants. Treatment of lupus nephritis.
Dosage/Direction for Use
Liver transplantation Adult Initially 0.1-0.15 mg/kg/day in 2 divided doses every 12 hr, to be administered no sooner than 6 hr after transplantation. In patients transferring from IV infusion to oral dosing, 1st oral dose should be given 8-12 hr after discontinuing IV infusion. Childn Initially 0.15-0.2 mg/kg/day in 2 divided doses every 12 hr. Kidney transplantation Adult Initially 0.2 mg/kg/day every 12 hr in 2 divided doses when in combination w/ azathioprine, or, 0.1 mg/kg/day every 12 hr in 2 divided doses when in combination w/ MMF & IL-2 receptor antagonist. Initial dose of may be administered w/in 24 hr of transplantation. Lupus nephritis Adult 3 mg once daily after supper.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2-3 hr after meals. Avoid grapefruit juice.
Contraindications
Special Precautions
Increased risk of development of post-transplant DM in Black & Hispanic kidney transplant patients. Hyperglycemia. Nephrotoxicity in high doses. Patients w/ persistent elevations of serum creatinine. Caution in concomitant w/ other nephrotoxic drugs. Do not use simultaneously w/ cyclosporine. Monitor serum K levels & do not use K-sparing diuretics during therapy. Neurotoxicity in high doses. Posterior reversible encephalopathy syndrome may develop. Risk of lymphoproliferative disorder in young childn who are at risk for primary Epstein-Barr virus infection. Increased risk for opportunistic infections & activation of latent viral infections including BK virus associated nephropathy & JC virus associated progressive multifocal leukoencephalopathy. Not recommended to use w/ sirolimus in heart transplant recipients. Patients w/ congenital long QT syndrome; CHF bradyarrhythmias, taking certain antiarrhythmic medications or other drugs that lead to QT prolongation, electrolyte disturbances eg, hypokalemia, hypocalcemia, hypomagnesemia. Avoid concomitant w/ St. John's wort. Risk factors for pure red cell aplasia (PRCA) eg, parvovirus B19 infection, underlying disease or concomitant drugs associated w/ PRCA. GI perforation. HTN; hyperkalemia; myocardial hypertrophy. Risk factor for the development of the CAD associated w/ systemic erythematosus especially in patients w/ lupus nephritis. DM. Impaired renal function or patients w/ renal insufficiency. Post-transplant hepatic impairment. Pregnancy. Avoid in lactation. Ped patients w/ lupus nephritis & on kidney transplant.
Adverse Reactions
Liver transplantation: Tremor, headache, diarrhea, HTN, nausea & abnormal renal function; diarrhea, sometimes associated w/ other GI complaints eg, nausea & vomiting; hyperkalemia & hypomagnesemia; hyperglycemia. Kidney transplantation: Infection, tremor, HTN, abnormal renal function, constipation, diarrhea, headache, abdominal pain & insomnia. Lupus nephritis: Increased urinary β2-microglobulin, increased urinary NAG, nasopharyngitis, hyperuricemia, leukocytosis, increased creatinine, diarrhea, increased BP & hyperglycemia.
Drug Interactions
Potential for additive or synergistic impairment of renal function w/ drugs that may be associated w/ renal dysfunction. Additive/synergistic nephrotoxicity w/ cyclosporine. Increased whole blood conc w/ CYP3A inhibitor. Decreased whole blood conc w/ CYP3A inducer. Reduced levels w/ St. John's wort. Increased mean AUC & decreased mean Cmax w/ Mg-/Al-hydroxide. Decreased oral bioavailability w/ rifampin (600 mg). Caution w/ HIV therapy eg, nephrotoxic drugs (eg, ganciclovir) or that are metabolized by CYP3A (eg, nelfinavir, ritonavir). Increased whole blood conc w/ most PIs (eg, ritonavir, telaprevir, boceprevir). May affect pharmacokinetics of other drugs (eg, phenytoin). May affect CYP3A-mediate metabolism w/ grapefruit juice. Not recommended in combination w/ sirolimus in prevention of graft rejection. Avoid use w/ live vaccines. Potential for increased mycophenolic acid (MPA) exposure after crossover from cyclosporine to tacrolimus in patients concomitantly receiving MMF or MPA.
MIMS Class
ATC Classification
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Prograf cap 1 mg
Packing/Price
50's
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