Advagraf

Advagraf

tacrolimus

Manufacturer:

Astellas Pharma

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tacrolimus (as monohydrate)
Indications/Uses
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Allograft rejection resistant to treatment w/ other immunosuppressants in adults.
Dosage/Direction for Use
Prophylaxis of kidney transplant rejection 0.2-0.3 mg/kg/day once daily in the morning w/in 24 hr post-op. Prophylaxis of liver transplant rejection 0.1-0.2 mg/kg/day once daily in the morning approx 12-18 hr post-op. Conversion of Prograf-treated patients to Advagraf Convert on 1:1 (mg:mg) total daily dose basis. Administer in the morning. Treatment of allograft rejection after heart transplantation Initially 0.15 mg/kg/day once daily in the morning.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2-3 hr after meals. Swallow whole w/ water. Avoid grapefruit juice.
Contraindications
Hypersensitivity to tacrolimus or other macrolides.
Special Precautions
Hypersensitivity to peanut or soya. Monitor BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), liver & renal function tests, haematology parameters, coagulation values, plasma protein determinations; tacrolimus blood levels when given w/ strong CYP3A4 inhibitors or inducers, or during diarrhoea episodes. Early & frequent monitoring of tacrolimus blood level w/in the 1st few days of coadministration w/ CYP3A4 inhibitors & inducers, & monitoring for renal function, QT prolongation w/ ECG, & other side effects. GI perforation, cardiomyopathies may occur. Preexisting heart disease, corticosteroid usage, HTN, renal or hepatic dysfunction, infections, fluid overload, oedema. May prolong the QT interval & may cause Torsades de Pointes. Patients w/ risk factors for & history of QT prolongation, CHF, bradyarrhythmias & electrolyte abnormalities; diagnosed or suspected congenital long QT syndrome or acquired QT prolongation; patients on concomitant drugs known to prolong the QT interval, induce electrolyte abnormalities or known to increase tacrolimus exposure. Epstein-Barr virus (EBV)-associated lymphoproliferative disorders; have EBV-viral capsid antigen (VCA) serology ascertained before starting treatment & monitor EBV-PCR carefully; concomitant use w/ antilymphocytic Ab may increase risk of EBV-associated lymphoproliferative disorders. Risk of opportunistic infections (bacterial, fungal, viral & protozoal). Limit sun & UV light exposure. Discontinue therapy immediately, have adequate BP & seizure control if posterior reversible encephalopathy is diagnosed. Pure red cell aplasia. Avoid coadministration w/ St. John's wort, ciclosporin, drugs known to have nephrotoxic or neurotoxic effects, live attenuated vaccine. Avoid high K intake or K-sparing diuretics. Non-Caucasian & patients at elevated immunological risk. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May cause visual & neurological disturbances. Severe liver impairment. Females & males of reproductive potential should use appropriate contraception prior to start of therapy. Pregnancy & lactation. 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 acidosis, 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, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paraesthesias & dysaesthesias, impaired writing; eye disorders, blurred vision, 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 signs & symptoms, vomiting, GI & abdominal pains, GI inflammatory conditions, haemorrhages, ulceration & perforation, ascites, stomatitis & ulceration, constipation, dyspeptic signs & symptoms, flatulence, bloating & distension, loose stools; bile duct disorders, hepatocellular damage & hepatitis, cholestasis & jaundice; rash, pruritus, alopecias, acne, increased sweating; arthralgia, back pain, muscle spasms, pain in extremity; acute renal failure, toxic nephropathy, renal tubular necrosis, urinary abnormalities, oliguria, bladder & urethral symptoms; febrile disorders, pain & discomfort, asthenic conditions, oedema, disturbed body temp perception, increased blood alkaline phosphatase, increased wt; primary graft dysfunction. Toxic epidermal necrolysis (Lyell's syndrome). Stevens Johnson syndrome.
Drug Interactions
Increased blood levels w/ CYP3A4 inhibitors, antifungal agents (eg, ketoconazole, fluconazole, itraconazole & voriconazole), erythromycin, HIV PIs (eg, ritonavir, nelfinavir, saquinavir), HCV PIs (eg, telaprevir, boceprevir), letermovir, clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, amiodarone, verapamil, danazol, ethinylestradiol, omeprazole, nefazodone, extr containing Schisandra sphenanthera, grapefruit juice. Potential inhibition of metabolism w/ bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin. Increased whole blood conc w/ lansoprazole & ciclosporin. Possible interactions w/ NSAIDs, oral anticoagulants, oral antidiabetics. Increased systemic exposure w/ prokinetics (eg, metoclopramide & cisapride), cimetidine, & Mg-Al hydroxide. Decreased blood levels w/ rifampicin, phenytoin, St. John's wort (Hypericum perforatum), phenobarb, corticosteroids, carbamazepine, metamizole, INH. Higher exposure of mycophenolic acid products. Increased or decreased blood levels w/ high dose prednisolone or methylprednisolone. Prolong t½ of ciclosporin. Increase blood level of phenytoin. May reduce clearance of steroid-based contraceptives. May potentially decrease clearance & increase t½ of pentobarbital & antipyrine. May increase nephrotoxic or neurotoxic effects of aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir, aciclovir. Enhanced nephrotoxicity w/ amphotericin B, ibuprofen. Increased preexisting hyperkalaemia w/ high K intake or K-sparing diuretics (eg, amiloride, triamterene or spironolactone). May lessen effect of live attenuated vaccines.
MIMS Class
ATC Classification
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Advagraf PR hard cap 0.5 mg
Packing/Price
5 × 10's
Form
Advagraf PR hard cap 3 mg
Packing/Price
5 × 10's
Form
Advagraf PR hard cap 1 mg
Packing/Price
5 × 10's
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