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Hecoria Generic Name & Formulations
Legal Class
Rx
General Description
Tacrolimus 0.5mg, 1mg, 5mg; caps.
Pharmacological Class
Immunosuppressant (calcineurin-inhibitor).
How Supplied
Caps—100
Manufacturer
Hecoria Indications
Indications
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).
Hecoria Dosage and Administration
Adult
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.
Children
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.
Hecoria Contraindications
Not Applicable
Hecoria Boxed Warnings
Not Applicable
Hecoria Warnings/Precautions
Warnings/Precautions
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.
Hecoria Pharmacokinetics
See Literature
Hecoria Interactions
Interactions
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.
Hecoria Adverse Reactions
Adverse Reactions
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.
Hecoria Clinical Trials
See Literature
Hecoria Note
Not Applicable
Hecoria Patient Counseling
See Literature
