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Prograf (Tacrolimus) - Summary



  • •Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions ( 5.2)].
  • •Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions ( 5.3, 5.4, 5.5)].
  • •Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. 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)].


Prograf is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus.

Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally.

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Published Studies Related to Prograf (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

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

Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults. [2011.11.17]
BACKGROUND: Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis. OBJECTIVES: We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial... CONCLUSION: Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated. Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

A new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients. [2011.11]
BACKGROUND: Tacrolimus (Tac) is a potent immunosuppressant with considerable toxicity. Tac pharmacokinetics varies between individuals and thus complicates its use in preventing rejection after kidney transplantation. This variability might be caused by genetic polymorphisms in metabolizing enzymes... CONCLUSIONS: The CYP3A4 rs35599367C>T polymorphism is associated with a significantly altered Tac metabolism and therefore increases the risk of supratherapeutic Tac concentrations early after transplantation. Analysis of this CYP3A4*22 SNP may help in identifying patients at risk of Tac overexposure.

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Clinical Trials Related to Prograf (Tacrolimus)

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).

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients [Completed]

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients [Completed]

more trials >>

Reports of Suspected Prograf (Tacrolimus) Side Effects

Drug Ineffective (350)Death (209)Acute Graft Versus Host Disease (183)OFF Label USE (177)Diarrhoea (75)Pneumonia (71)Chronic Graft Versus Host Disease (70)Hospitalisation (69)Treatment Noncompliance (65)Renal Failure Acute (65)more >>


Based on a total of 1 ratings/reviews, Prograf has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.

Prograf review by care giver of 69 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   ANTI-REJECTION
Dosage & duration:   2 MG taken twice daily for the period of OVER ONE YEAR
Other conditions:   high blood pressure
Other drugs taken:   cellcept, valacyte,
Reported Results
Benefits:   Have not had any issues with rejection. Patient has now be diagonosed with the JC virus, which has been a side effect of Cellcept. Blood test must be taken weekly to check the fine line of not have to much or to little of the prograf in the system. If patient did not have the JC virus, blood test would be less frequent.
Side effects:   Possible side effects, sleeps a lot.
Comments:   Patient recieved a kidney and pancreas transplant in Jan of 2008 after being on dialaylis for 3 plus years.

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Page last updated: 2014-12-01

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