Astellas Pharma


Concise Prescribing Info
Prophylaxis of transplant rejection in adult kidney or liver allograft receipients. Kidney or liver allograft rejection resistant to treatment w/ other immunosuppressive medicinal products in adult patients.
Dosage/Direction for Use
Prophylaxis of kidney transplant rejection Initially 0.2-0.3 mg/kg daily once daily in the morning w/in 24 hr after completion of surgery. Prophylaxis of liver transplant rejection Initially 0.1-0.2 mg/kg daily once daily in the morning 12-18 hr after completion of surgery.
Should be taken on an empty stomach: Take at least 1 hr before or 2-3 hr after meals. Swallow whole w/ water.
Hypersensitivity to tacrolimus or other macrolides.
Special Precautions
Hypersensitivity to peanut or soya. GI disorders; pure red cell aphasia; risk factors for QT prolongation including patients w/ personal or family history of QT prolongation, CHF, bradyarrhythmia, electrolyte abnormalities, diagnosed or suspected congenital long QT syndrome or acquired QT prolongation; lymphoproliferative disorders & malignancies; posterior reversible encephalopathy syndrome. Increased risk of opportunistic infections eg, BK virus-associated nephropathy, JC virus-associated progressive multifocal leukoencephalopathy, viral hepatitis. Monitor BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), hepatic & renal function tests, haematology parameters, coagulation values & plasma protein determinations, EBV-PCR during initial post-transplant period. Concomitant use w/ strong CYP3A4 inhibitors/inducers, nephrotoxic or neurotoxic drugs; drugs prolonging QT interval, inducing electrolyte abnormalities or increasing tacrolimus exposure. Avoid use w/ St. John's wort-containing herbal prep, ciclosporin, high K or K-sparing diuretic therapy, live vaccines. Limit exposure to sunlight & UV light. Black patients; non-Caucasian patients & patients at elevated immunological risk. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Renal & severe hepatic impairment. May affect male fertility. Pregnancy. Not to be used during lactation. Not recommended in childn <18 yr.
Adverse Reactions
DM, hyperglycaemic conditions, hyperkalaemia; insomnia; headache, tremor; HTN; diarrhoea, nausea; abnormal liver function tests; renal impairment. Anaemia, thrombocytopenia, leukopenia, abnormal RBC analyses, leukocytosis; metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, decreased appetite, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia; confusion, disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders & disturbances, nightmare; nervous system disorders; eye disorders, vision blurred, photophobia; tinnitus; ischaemic CAD, tachycardia; thromboembolic & ischaemic events, vascular hypotensive disorders, haemorrhage, peripheral vascular disorders; parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion & inflammations; GI disorders; bile duct disorders, hepatocellular damage & hepatitis, cholestasis, jaundice; rash, pruritus, alopecias, acne, increased sweating; arthralgia, back pain, muscle spasms, pain in extremity; renal & urinary disorders; febrile disorders, pain & discomfort, asthenic conditions, oedema, disturbed body temp perception, increased blood alkaline phosphatase, increased wt; primary graft dysfunction.
Drug Interactions
Increased blood levels w/ ketoconazole, fluconazole, itraconazole, voriconazole, isavuconazole, erythromycin, HIV & HCV PIs, letermovir, cobicistat, nilotinib, imatinib; clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone, Schisandra sphenanthera-containing herbal remedies; grapefruit juice; NSAIDs, oral anticoagulants, oral antidiabetics; metoclopramide, cisapride, cimetidine, Mg-Al-hydroxide. Inhibited metabolism w/ bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl) oleandomycin; lansoprazole, ciclosporin. Decreased blood levels w/ rifampicin, phenytoin, St. John's wort; phenobarb; carbamazepine, metamizole, INH. Increased or decreased blood levels w/ high-dose prednisolone or methylprednisolone. Prolonged t½ of ciclosporin. Increased blood level of phenytoin. Reduced clearance of steroid-based contraceptives. Potentially decreased clearance & increased t½ of pentobarbital & antipyrine. Increased nephrotoxic or neurotoxic effects w/ aminoglycosides, gyrase inhibitors, vancomycin, co-trimoxazole, NSAIDs, ganciclovir, aciclovir. Enhanced nephrotoxicity w/ amphotericin B & ibuprofen. Risk of hyperkalaemia w/ high K intake or K-sparing diuretics (eg, amiloride, triamterene or spironolactone). Avoid use w/ live vaccines.
MIMS Class
ATC Classification
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
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