Loading…
APO-TACROLIMUS is a brand name for Tacrolimus, supplied as a capsule (immediate release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Transplantation APO-TACROLIMUS CAPSULES (tacrolimus) is indicated for: • prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. • treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants. APO-TACROLIMUS CAPSULES is to be used…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Due to intersubject variability following dosing with tacrolimus, individualization of the dosing regimen is necessary for optimal therapy. Additional factors that may impact dosing include pre-existing conditions, such as renal or hepatic impairment, race, pediatric use and the concomitant use of other medications.
Tacrolimus has been used in combination with azathioprine. Tacrolimus has been used in combination with mycophenolate mofetil (MMF) in patients receiving deceased donor kidney transplants and heart transplants. Medication errors, including inadvertent, unintentional or unsupervised substitution of tacrolimus (immediate release) or extended-release tacrolimus formulations, have been observed.
This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over-exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist.
Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained. 2 Recommended Dose and Dosage Adjustment The initial dose of APO-TACROLIMUS CAPSULES should be administered no sooner than 6 hours after transplantation.
Adult patients should receive doses at the lower end of the dosing range. Concomitant adrenal corticosteroid therapy is recommended early post-transplantation. 3 mg/kg/day administered every 12 hours in two divided doses. The initial dose of APO-TACROLIMUS CAPSULES may be administered within 24 hours of transplantation but should be delayed until renal function has recovered (as indicated, for example, by a serum creatinine ≤ 4 mg/dL).
Black patients may require higher doses to achieve comparable blood levels. Dosage and typical tacrolimus whole blood trough concentrations are shown in the table below; blood concentration details are described under 7 WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests -Blood Concentration Monitoring.
3 mg/kg/day Dosing Regimen two divided doses, q12h Typical tacrolimus whole blood trough concentrations Month 1 to 3 Month 4 to 12 7 to 20 ng/mL 5 to 15 ng/mL Liver Transplantation It is recommended that patients be converted from IV to oral tacrolimus as soon as oral therapy can be tolerated.
). Mild or moderate hypertension is more frequently reported than severe hypertension. The incidence of hypertension decreases over time. Antihypertensive therapy may be required; the control of blood pressure can be accomplished with any of the common antihypertensive agents.
Since tacrolimus may cause hyperkalemia, potassium-sparing diuretics should be avoided. While calcium channel blocking agents can be effective in treating tacrolimus-associated APO-TACROLIMUS CAPSULES (Tacrolimus Immediate Release Capsules) Page 12 of 95 hypertension, care should be taken since interference with tacrolimus metabolism may require a dosage reduction in the transplant patient (see
, Hematologic 12/2023 7 WARNINGS AND PRECAUTIONS, Immune 12/2023 7 WARNINGS AND PRECAUTIONS, Renal 12/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................... 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS ......................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ........................................................................................................... 5 Missed Dose...............................................................................................................
9 5 OVERDOSAGE ................................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 9 7 WARNINGS AND PRECAUTIONS .....................................................................................
• APO-TACROLIMUS CAPSULES is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tacrolimus in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
This usually occurs within 2 to 3 days. The first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion1. 15 mg/kg/day administered in two divided daily doses every 12 hours. The initial dose of APO-TACROLIMUS CAPSULES should be administered no sooner than 6 hours after transplantation.
Adult patients should receive doses at the lower end of the dosing range. Some centres use lower tacrolimus doses during maintenance therapy post-transplantation. Dosing should be titrated based on clinical assessment of rejection and tolerability.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. 075 mg/kg/day administered every 12 hours in two divided doses. It is recommended that patients initiate oral therapy with APO-TACROLIMUS CAPSULES if possible.
If IV therapy is necessary, conversion from IV to oral APO-TACROLIMUS CAPSULES is recommended as soon as oral therapy can be tolerated1. This usually occurs within 2 to 3 days. The initial dose of APO-TACROLIMUS CAPSULES should be administered no sooner than 6 hours after transplantation.
In a patient receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion1. Dosing should be titrated based on clinical assessments of rejection and tolerability. Lower APO-TACROLIMUS CAPSULES dosages may be sufficient as maintenance therapy.
Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. Rheumatoid Arthritis The recommended adult oral dose of APO-TACROLIMUS CAPSULES is 3 mg, administered once a day. Regular monitoring of APO-TACROLIMUS CAPSULES-treated patients for occurrence of adverse events is mandatory.
1 APO-TACROLIMUS CAPSULES is not available in the intravenous form APO-TACROLIMUS CAPSULES (Tacrolimus Immediate Release Capsules) Page 8 of 95 Patients with Hepatic or Renal Dysfunction Due to the potential for nephrotoxicity, patients with renal or hepatic impairment should receive doses at the lowest value of the recommended oral dosing ranges.
Further reductions in dose below these ranges may be required. Conversion from Cyclosporine to Tacrolimus Tacrolimus should not be used simultaneously with cyclosporine. Patients converted from cyclosporine to APO-TACROLIMUS CAPSULES should receive the first APO-TACROLIMUS CAPSULES dose no sooner than 24 hours after the last cyclosporine dose.
Dosing may be further delayed in the presence of elevated cyclosporine levels. Conversion from Tacrolimus to Cyclosporine Patients converted from APO-TACROLIMUS CAPSULES to cyclosporine should receive the first cyclosporine dose no sooner than 24 hours after the last APO-TACROLIMUS CAPSULES dose.
Dosing may be further delayed in the presence of elevated tacrolimus levels. Pediatric Patients Pediatric liver transplantation patients without pre-existing renal or hepatic dysfunction have required and tolerated higher doses than adults to achieve similar blood concentrations.
Therefore, it is recommended that […]
1 Special Populations .................................................................................................. 1 Pregnant Women ..................................................................................................
2 Breast-feeding ...................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics .............................................................................................................. 19 8 ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions................................................................................ 3 Less Common Clinical Trial Adverse Reactions.........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .............................................................................................................. 5 Post-Market Adverse Reactions ...............................................................................
34 9 DRUG INTERACTIONS ..................................................................................................... 2 Drug Interactions Overview .....................................................................................
3 Drug-Behavioural Interactions ................................................................................. 4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions ............................................................................................
6 Drug-Herb Interactions ............................................................................................ 7 Drug-Laboratory Test Interactions ........................................................................... 43 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action ............................................................................................... 2 Pharmacodynamics ..................................................................................................
3 Pharmacokinetics ..................................................................................................... 44 11 STORAGE, STABILITY AND DISPOSAL ..............................................................................
53 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 53 PART II: SCIENTIFIC INFORMATION ........................................................................................
54 13 PHARMACEUTICAL INFORMATION ................................................................................. 54 14 CLINICAL TRIALS .............................................................................................................
1 Trial Design and Study Demographics ...................................................................... 2 Study Results ...........................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 68 15 MICROBIOLOGY […]