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Manufacturer Astellas 
Distributor Hong Kong: DKSH/Macau: Firma Chun Cheong 
Contents Tacrolimus
Indications Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment w/ other immunosuppressants in adults.
Dosage 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. Conversion of heart transplantation 0.15 mg/kg/day once daily in the morning. Lung-transplanted patient 0.1-0.15 mg/kg/day. Pancreas-transplanted patient 0.2 mg/kg/day. Intestine-transplanted patient 0.3 mg/kg/day.
Administration Should be taken on an empty stomach (Take on an empty stomach at least 1 hr before or 2-3 hr after meals. Swallow whole, do not chew/crush. Avoid consumption of grapefruit or grapefruit juice. ).
Contraindications Hypersensitivity to macrolides. Lactation.
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, EBV-PCR during initial post-transplant period. Concomitant administration w/ St. John's wort or other herbal prep, ciclosporin. Episodes of diarrhoea. Monitor high-risk patients receiving substantial immunosuppression using echocardiography or ECG pre- & post-transplant (eg initially at 3 mth & then 9-12 mth). Diagnosed or suspected Congenital Long QT Syndrome. Perform EBV-VCA serology before use. Increase risk of opportunistic infections eg BK virus-associated nephropathy & JC virus-associated progressive multifocal leukoencephalopathy. Monitor symptoms of posterior reversible encephalopathy syndrome. Limit exposure to sunlight & UV light. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hypersensitivity to peanut or soya. May impair ability to drive or operate machinery. Pregnancy.
Adverse Drug Reactions Tremor, headache, diarrhoea, nausea, renal impairment, hyperglycaemic conditions, DM, hyperkalaemia, HTN, insomnia.
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Drug Interactions CYP 3A4 inducers & inhibitors; antifungal agents eg ketoconazole, itraconazole, voriconazole; erythromycin; HIV protease inhibitors eg ritonavir; bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandromycin, grapefruit juice, lansoprazole, ciclosporin; rifampicin, phenytoin, St. John's wort; ciclosporin, phenobarb, corticosteroids, carbamazepine, metamizole, INH; prokinetic agents eg metoclopromide, cisapride; cimetidine, Mg-Al hydroxide; nephrotoxic or neurotoxic drugs eg aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or acyclovir, amphotericin B, ibuprofen; K-sparing diuretics; live attenuated vaccines; oral anticoagulants & antidiabetics.
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Pregnancy Category (US FDA)      
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. 
ATC Classification D11AH01 - tacrolimus ; 
Presentation/Packing
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Advagraf prolonged-release capsule  Advagraf 0.5 mg x 50's
Advagraf 1 mg x 50's
Advagraf 5 mg x 50's
 

Manufacturer: Astellas
Distributor: Hong Kong: DKSH
Macau: Firma Chun Cheong