Generic Name and Formulations:
Tacrolimus 0.5mg, 1mg, 5mg; caps.
Novartis Pharmaceuticals Corp
Indications for HECORIA:
Organ rejection prophylaxis in allogeneic hepatic transplant patients, in combination with corticosteroids; or in cardiac and renal transplant patients in combination with corticosteroids, azathioprine, or mycophenolate mofetil (MMF).
If previously on IV infusion, initial oral dose may be given 8–12hrs post infusion. Adjunct therapy with corticosteroids is recommended early post-transplant. Hepatic, cardiac: give no sooner than 6hrs after transplantation. Renal: may be given within 24hrs of transplantation but should be delayed until renal function has recovered. Hepatic: initially 0.1–0.15mg/kg/day in two divided dose every 12hrs. Cardiac: initially 0.075mg/kg/day in two divided doses every 12hrs. Renal: initially 0.2mg/kg/day in two divided doses every 12hrs in combination with azathioprine; or 0.1mg/kg/day in two divided doses every 12hrs in combination with MMF and IL-2 receptor antagonist; black patients may require higher doses. Renal or hepatic impairment: use lowest effective dose (see full labeling). Post-op oliguria: may delay therapy until renal function recovers.
If previously on IV infusion, initial oral dose may be given 8–12hrs post infusion. Adjunct therapy with corticosteroids is recommended early post-transplant. Hepatic: initially 0.15–0.2mg/kg/day in two divided doses every 12hrs. Give no sooner than 6hrs after transplantation.
Increased risk of infections (eg, bacterial, viral, fungal, protozoal, cytomegalovirus), opportunistics infections including polyoma virus. Increased risk of lymphomas and other malignancies (eg, skin). Avoid sun, UV light. Epstein Barr Virus seronegative. Diabetes: monitor for hyperglycemia. Hepatic or renal impairment; monitor and consider dose reduction. Obtain tacrolimus blood concentrations, serum creatinine, potassium, and fasting glucose periodically. Discontinue or reduce dose if myocardial hypertrophy occurs. Pregnancy (Cat.C), nursing mothers: not recommended.
Concomitant sirolimus, live vaccines: not recommended. Concomitant mycophenolic acid (MPA) products: can increase MPA exposure after crossover from cyclosporine to tacrolimus; monitor and adjust doses. Concomitant strong CYP3A4 inhibitors/inducers or substrates: must adjust dosing regimen, closely monitor tacrolimus blood concentrations and for QT prolongation. Avoid potassium-sparing diuretics, grapefruit juice, nelfinavir. Additive nephrotoxicity with cyclosporine (discontinue at least 24hrs prior to initiating the other drug), aminoglycosides, ganciclovir, amphotericin B, cisplatin, tenofovir, ritonavir, indinavir. May be potentiated by calcium channel blockers (eg, verapamil, diltiazem, nifedipine), antifungals (eg, fluconazole, ketoconazole), macrolides (eg, troleandomycin, clarithromycin, erythromycin), metoclopramide, lansoprazole, omeprazole, bromocriptine, chloramphenicol, cimetidine, cyclosporine, danazol, ethinyl estradiol, amiodarone, methylprednisolone, protease inhibitors (eg, telaprevir, boceprevir, ritonavir), nefazodone, magnesium-aluminum-hydroxide. May be antagonized by carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, caspofungin, St. Johns Wort.
Tremor, headache, diarrhea, nausea, constipation, abdominal pain, insomnia, hypertension, abnormal renal function, infections (eg,viral, cytomegalovirus, polyoma virus), anemia, hypophosphatemia, hyperkalemia, hypomagnesemia, hyperglycemia, nephrotoxicity or neurotoxicity (esp. in high doses), JC virus-associated progressive multifocal leukoencephalopathy, post-transplant diabetes mellitus, posterior reversible encephalopathy syndrome (consider reduced dose or discontinue), malignancies (eg, lymphomas, skin), post-transplant lymphoproliferative disorder, myocardial hypertrophy, pure red cell aplasia.
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