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ADVAGRAF is a brand name for Tacrolimus, supplied as a capsule (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: De novo Advagraf® (tacrolimus extended-release capsules) is indicated for prophylaxis of organ rejection in adult patients receiving allogeneic kidney and liver transplants. Advagraf is to be used concomitantly with adrenal corticosteroids and mycophenolate mofetil (MMF) in de novo renal transplant recipients and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
Medication errors, including inadvertent, unintentional or unsupervised substitution of Prograf (immediate-release) or Advagraf (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.
Patients converting from Prograf (immediate-release formulation) to Advagraf (extended-release formulation) should be administered a single daily morning dose of Advagraf equivalent to the patient’s previous stable total daily dose of Prograf (immediate-release formulation).
Subsequent doses of Advagraf should be adjusted in order to maintain trough concentrations similar to those prior to conversion. Due to intersubject variability following dosing with tacrolimus, individualization of the dosing regimen is necessary for optimal therapy.
Advagraf is to be used concomitantly with adrenal corticosteroids and mycophenolate mofetil (MMF) in de novo renal transplant recipients. Antibody induction therapy should be used in kidney transplant recipients. Advagraf is to be used concomitantly with adrenal corticosteroids in de novo liver transplants.
2 Recommended Dose and Dosage Adjustment Initial dosage and typical tacrolimus whole blood trough concentrations are shown in Table 1 below; blood concentration details are described under 7 Warnings and Precautions – Monitoring and Laboratory Tests - Blood Concentration Monitoring.
20 mg/kg administered once daily in the morning. The initial dose of Advagraf should be administered within 24 hours of kidney transplantation and within 12-18 hours of liver transplantation. Dosing should be titrated to maintain the whole blood trough concentration levels noted above; blood concentration details are described under 7 Warnings and Precautions – Monitoring and Laboratory Tests - Blood Concentration Monitoring.
1 Adverse Reaction Overview The most common adverse reactions reported were infection, tremor, hypertension, decreased renal function, constipation, diarrhea, headache, abdominal pain and insomnia. Many of these adverse reactions were mild and responded to a reduction in dosage.
Insulin-dependent post-transplant diabetes mellitus (PTDM) was related to increased whole blood trough concentrations of tacrolimus and higher doses of corticosteroids. The median time to onset of PTDM was 68 days. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Advagraf® (tacrolimus) Page 18 of 62 Protected B / Protégé B Kidney In a large (n=668), phase III, randomized, comparative trial, de novo kidney transplant recipients received either Advagraf (extended-release formulation) plus mycophenolate mofetil (MMF) or Prograf (immediate-release formulation) plus MMF or Neoral plus MMF.
All three regimens included corticosteroids and basiliximab induction. The incidence of adverse events that occurred in 15% of Advagraf-treated de novo kidney transplant recipients is shown in Table 5 below. 1 mg/kg/day in two divided doses).
Both regimens included corticosteroids. The incidence of adverse events that occurred in 15% of Advagraf-treated de novo liver transplant recipients is shown in Table 6. The most common events among recipients who received Advagraf (≥ 15% of patients in the Advagraf group) were anemia, diarrhea, hyperglycemia, hypertension, pleural effusion, pyrexia, renal insufficiency and thrombocytopenia.
1. Pregnancy 2025/12 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ...............................................................................................................
2 PART 1: HEALTHCARE PROFESSIONAL INFORMATION ............................................................. 5 1 INDICATIONS ....................................................................................................................
1 Pediatrics ................................................................................................................... 2 Geriatrics ...................................................................................................................
5 2 CONTRAINDICATIONS ....................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................................
6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 3 Reconstitution ........................................................................................................... 4 Administration ...........................................................................................................
5 Missed Dose .............................................................................................................. 9 5 OVERDOSE........................................................................................................................
Advagraf (tacrolimus extended-release capsules) is contraindicated in patients with hypersensitivity to tacrolimus or to any ingredient in the formulation or component of the capsules. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Advagraf® (tacrolimus) Page 6 of 62 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Conversion from Prograf (immediate-release formulation) to Advagraf (extended-release formulation) Stable kidney and liver transplant recipients can be converted from Prograf (immediate-release formulation) twice daily to once-daily Advagraf (extended-release formulations).
Patients converting from Prograf (immediate-release formulation) to Advagraf (extended-release formulation) should be administered a single daily morning dose of Advagraf (extended-release formulation) equivalent to the patient’s previous stable total daily dose of Prograf (immediate-release formulation).
The same target trough range and whole blood trough concentration monitoring should be used as with Prograf (immediate-release formulation) in order to maintain whole blood trough concentrations of tacrolimus similar to those prior to conversion.
In patients unable to take oral Advagraf (extended-release) capsules, therapy may be initiated with Prograf injection and the patient subsequently converted to oral Advagraf. 05 mg/kg/day (kidney) as a continuous IV infusion. Adult patients should receive doses at the lower end of the dosing range.
In a liver conversion adult study from Prograf (immediate-release formulation) to Advagraf (extended-release formulation) (n=62), Advagraf dose adjustments were needed in approximately 16% of patients in the early conversion period.
After conversion, it is strongly recommended that the tacrolimus blood trough be monitored every 4-7 days until stable within the desired therapeutic range. Patients with Hepatic or Renal Dysfunction Advagraf (extended-release formulation) has not been studied in patients with hepatic or renal dysfunction; the following are based on experiences obtained from use of Prograf (immediate-release formulation).
Advagraf® (tacrolimus) Page 8 of 62 Protected B / Protégé B Due to the reduced clearance and prolonged half-life, patients with severe hepatic impairment (Pugh 10) may require lower doses of Advagraf. Close monitoring of blood concentrations is warranted.
Due to the potential for nephrotoxicity in patients with renal or hepatic impairment, these patients should receive doses at the lowest value of the recommended oral dosing range. Further reductions in dose below these ranges may be required.
Conversion from Cyclosporine to Advagraf Tacrolimus should not be used simultaneously with cyclosporine. Patients converted from cyclosporine to Advagraf should receive the first Advagraf dose no sooner than 24 hours after the last cyclosporine dose.
Dosing may be further delayed in the […]
5% The following adverse events were also reported in clinical studies of solid organ transplant recipients who were treated with Advagraf at a frequency of 3% to < 15%: Advagraf® (tacrolimus) Page 20 of 62 Protected B / Protégé B Blood and Lymphatic System Disorders: leukopenia, secondary anemia, leukocytosis, pancytopenia; Cardiac Disorders: atrial fibrillation, tachycardia; Gastrointestinal Disorders: abdominal pain, abdominal pain upper, ascites, constipation, dyspepsia, flatulence, gastroenteritis, nausea, vomiting; General Disorders and Administration Site Conditions: asthenia, chest pain, edema, peripheral edema, pyrexia, pain; Hepatobiliary Disorders: bile duct stenosis, cholestasis, cytolytic hepatitis, hepatic artery stenosis, hyperbilirubinemia; Infections and Infestations: bacterial urinary tract infection, bacterial pneumonia, bacterial sepsis, biliary tract infection, cytomegalovirus infection, hepatitis C, herpes simplex, influenza, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, wound infection; Injury, Poisoning and Procedural Complications: graft dysfunction, incision site complication, necrotic preservation injury or graft, post-procedural bile leak; Investigations: abnormal liver function test, increased blood glucose, increased blood creatinine, hepatic enzyme increased, hepatitis C virus; Metabolism and Nutrition Disorders: dehydration, metabolic acidosis, hyperkalemia, hyperuricemia, noninsulin-dependent diabetes mellitus, hypoalbuminemia, hypocalcemia, hypokalemia, diabetes mellitus, hypomagnesemia, hyperlipidemia, hyponatremia, […]
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING ..................................... 9 7 WARNINGS AND PRECAUTIONS...................................................................................... 10 General ................................................................................................................................
10 Carcinogenesis and Genotoxicity ......................................................................................... 11 Cardiovascular .....................................................................................................................
12 Driving and Operating Machinery ........................................................................................ 12 Gastrointestinal ...................................................................................................................
12 Hematologic......................................................................................................................... 12 Hepatic/Biliary/Pancreatic ...................................................................................................
13 Immune ............................................................................................................................... 13 Monitoring and Laboratory Tests ........................................................................................
14 Advagraf® (tacrolimus) Page 3 of 62 Protected B / Protégé B Neurologic ........................................................................................................................... 15 Renal ....................................................................................................................................
15 Reproductive Health ............................................................................................................ 1 Special Populations..................................................................................................
1 Pregnancy ........................................................................................................ 2 Breastfeeding .................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 17 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 ..............................................................................
22 9 DRUG INTERACTIONS ..................................................................................................... 2 Drug Interactions Overview .....................................................................................
3 Drug-Behaviour Interactions ................................................................................... 4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food Interactions............................................................................................
6 Drug-Herb Interactions ............................................................................................ 31 […]