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Astagraf XL (Tacrolimus) - Summary



  • Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe ASTAGRAF XL. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.1)].

Malignancies and Serious Infections

  • Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression [see Warnings and Precautions (5.2, 5.3, 5.6, 5.7)].

Mortality in Liver Transplantation

  • Increased mortality in female transplant recipients was observed in a clinical trial of liver transplantation. Use in liver transplantation is not recommended [see Warnings and Precautions (5.4)].


Tacrolimus is the active ingredient in ASTAGRAF XL. Tacrolimus is a macrolide immunosuppressant produced by Streptomyces tsukubaensis.

Prophylaxis of Organ Rejection in Kidney Transplant

ASTAGRAF XL is indicated for the prophylaxis of organ rejection in patients receiving a kidney transplant. It is recommended that ASTAGRAF XL be used concomitantly with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction [ see Clinical Studies (14) ]. Therapeutic drug monitoring is recommended for all patients receiving ASTAGRAF XL [ see Dosage and Administration (2.5) ] .

Limitations of Use

  • •ASTAGRAF XL extended-release capsules are not interchangeable or substitutable with tacrolimus immediate-release capsules.
  • •ASTAGRAF XL should not be used simultaneously with cyclosporine.

See all Astagraf XL indications & dosage >>


Published Studies Related to Astagraf XL (Tacrolimus)

Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral erosive lichen planus: a 8 week randomized double-blind controlled study. [2014]
CONCLUSION: Both medications would currently appear to be a treatment of choice

Topical tacrolimus significantly promotes repigmentation in idiopathic guttate hypomelanosis: a double-blind, randomized, placebo-controlled study. [2013]
compared with placebo in the treatment of IGH... CONCLUSION: Topical 0.1% tacrolimus ointment appeared to be an effective and safe

Long-term tacrolimus-based immunosuppressive treatment for young patients with lupus nephritis: a prospective study in daily clinical practice. [2012]
immunosuppressive treatment of young patients with LN in daily clinical practice... CONCLUSION: The data suggest that long-term, relatively low-dose Tac-based

Comparative efficacy of tacrolimus 0.1% ointment and clobetasol propionate 0.05% ointment in oral lichen planus: a randomized double-blind trial. [2012]
Oral lichen planus (OLP) is a common disease of the oral mucosa with worldwide distribution and overall prevalence of 0.5-2.2%. Its etiology remains unclear, although the role of autoimmunity is supported by its association with other autoimmune diseases and the presence of auto-cytotoxic T cell clones in the lesions...

A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05% clobetasol propionate ointment in discoid lupus erythematosus by modified cutaneous lupus erythematosus disease area and severity index. [2012]
CONCLUSION: The present study proved the efficacy of twice-daily tacrolimus and

more studies >>

Clinical Trials Related to Astagraf XL (Tacrolimus)

A Multicenter Study in Liver Transplant Patients Converted From Prograf� to Advagraf� During the First Post-transplantation Year [Recruiting]
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Pharmacokinetic Studies of Tacrolimus in Transplant Patients [Completed]
The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients [Completed]
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.

A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf) to the Once Per Day Form (Advagraf) [Recruiting]
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf) to the tacrolimus once per day form (Advagraf) with follow-up at one year. Analysis of two groups of patients: patients converted from Prograf to Advagraf early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

Pharmacokinetic Comparison Of All FK-506 Formulations [Active, not recruiting]

more trials >>

Page last updated: 2015-08-10

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