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Prograf (Tacrolimus) - Summary



Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. 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.



tacrolimus capsules
tacrolimus injection (for intravenous infusion only)

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.

See all Prograf indications & dosage >>


Media Articles Related to Prograf (Tacrolimus)

Tacrolimus Comes Out Tops for Lupus Nephritis (CME/CE)
Source: MedPage Today Rheumatology [2015.07.24]
(MedPage Today) -- Meta-analysis compares the available immunosuppressants.

Organ rejection can be overcome, shows mouse study
Source: Transplants / Organ Donations News From Medical News Today [2015.07.08]
The immune system's 'memory' of rejecting a first organ transplant is not necessarily permanent, suggest the results of a new study.

more news >>

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.

more studies >>

Clinical Trials Related to Prograf (Tacrolimus)

A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients [Active, not recruiting]
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation [Active, not recruiting]
The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation [Active, not recruiting]
The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects [Completed]

Comparative Study of Modified Release (MR) Tacrolimus/MMF in de Novo Kidney Transplant Recipients [Active, not recruiting]

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.

See all Prograf reviews / ratings >>

Page last updated: 2015-07-24

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