Firma Chun Cheong
Concise Prescribing Info
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment w/ other immunosuppressants in adults.
Dosage/Direction for Use
Prophylaxis of kidney transplant rejection Initially 0.2-0.3 mg/kg/day once daily in the morning w/in 24 hr after surgery. Prophylaxis of liver transplant rejection Initially 0.1-0.2 mg/kg/day once daily in the morning approx 12-18 hr after surgery. Treatment of allograft rejection after kidney or liver transplantation Increased doses of tacrolimus, supplemental corticosteroid therapy, & introduction of short courses of mono-/polyclonal Ab have been used to manage rejection episodes. Conversion from other immunosuppressants to Advagraf: Begin w/ the initial oral dose recommended for primary immunosuppression. Treatment of allograft rejection after heart transplantation Initially 0.15 mg/kg/day once daily in the morning. Treatment of allograft rejection after lung transplantation Initially 0.1-0.15 mg/kg/day. Treatment of allograft rejection after pancreas transplantation Initially 0.2 mg/kg/day. Treatment of allograft rejection after intestinal transplantation Initially 0.3 mg/kg/day.
Should be taken on an empty stomach: Take at least 1 hr before or 2-3 hr after meals. Swallow whole, do not chew/crush. Avoid grapefruit & grapefruit juice.
Hypersensitivity to tacrolimus, to any of the excipients, or other macrolides.
Special Precautions
Monitor significant changes in BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), liver & renal function tests, haematology parameters, coagulation values & plasma protein determinations during initial post-transplant period. Reports of GI perforation. Perform extra monitoring of tacrolimus conc during episodes of diarrhoea. Reports of cardiomyopathy; monitor high-risk patients receiving substantial immunosuppression using echocardiography or ECG pre- & post-transplant (eg, initially at 3 mth & then 9-12 mth). May prolong QT interval & cause Torsades de Pointes. Reports of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. Perform EBV-VCA serology before starting treatment. Increase risk of opportunistic infections eg, BK virus-associated nephropathy & JC virus-associated progressive multifocal leukoencephalopathy. Risk of posterior reversible encephalopathy syndrome. Cases of pure red cell aplasia. Limit exposure to sunlight & UV light. Non-Caucasian patients & patients at elevated immunological risk (eg, retransplantation, evidence of panel reactive Ab). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hypersensitivity to peanut or soya. Concomitant use w/ strong CYP3A4 inhibitors or inducers. Avoid concomitant use w/ St. John's wort or other herbal prep; combined administration w/ ciclosporin; high K intake or K-sparing diuretics; drugs known to have nephrotoxic or neurotoxic effects; live attenuated vaccines. May cause visual & neurological disturbances. Severe liver impairment. Pregnancy & lactation. Not recommended for use in childn <18 yr.
Adverse Reactions
Tremor, renal impairment, hyperglycaemic conditions, DM, hyperkalaemia, infections, HTN & insomnia.
Drug Interactions
Increased tacrolimus blood levels w/ CYP3A4 inhibitors: antifungal agents eg, ketoconazole, fluconazole, itraconazole, voriconazole; erythromycin; HIV protease inhibitors eg, ritonavir, nelfinavir, saquinavir, HCV protease inhibitors eg, telaprevir, boceprevir; clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone, herbal remedies containing extr of Schisandra sphenanthera; bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandromycin; grapefruit juice; lansoprazole, ciclosporin. Increased tacrolimus blood levels w/ other active substances known to have high affinity for plasma proteins (eg, NSAIDs, oral anticoagulants, oral antidiabetics); prokinetic agents (eg, metoclopramide, cisapride); cimetidine; Mg-Al hydroxide. Decreased tacrolimus blood levels w/ rifampicin, phenytoin, St. John's wort; phenobarb; maintenance doses of corticosteroids; carbamazepine, metamizole, INH. Increased or decreased tacrolimus blood levels w/ high dose prednisolone or methylprednisolone. May affect metabolism of CYP3A4 substrates. Prolonged t½ of ciclosporin. Synergistic/additive nephrotoxic effects w/ ciclosporin. Increased blood levels of phenytoin. Reduced clearance of steroid-based contraceptives. Increased toxic effects w/ medicinal products known to have nephrotoxic or neurotoxic effects (eg, aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or acyclovir). Enhanced nephrotoxicity w/ amphotericin B & ibuprofen. Increased risk of hyperkalaemia w/ high K intake or K-sparing diuretics.
MIMS Class
ATC Classification
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Advagraf PR cap 0.5 mg
Advagraf PR cap 1 mg
Advagraf PR cap 5 mg
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