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Prograf (Tacrolimus) - Summary

 
 



WARNING

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.

 

PROGRAF SUMMARY

PROGRAF®
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 >>

NEWS HIGHLIGHTS

Published Studies Related to Prograf (Tacrolimus)

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.

Double-blind, placebo-controlled trial of oral tacrolimus (FK506) in the management of hospitalized patients with steroid-refractory ulcerative colitis. [2011.09.01]
BACKGROUND: We report a multicenter study of oral tacrolimus (FK506) therapy in steroid-refractory ulcerative colitis (UC)... CONCLUSIONS: Oral tacrolimus therapy in patients with steroid-refractory UC shortened the acute phase and induced rapid mucosal healing. These results suggest that tacrolimus therapy is useful as an alternative therapy for steroid-refractory UC. (Inflamm Bowel Dis 2011;). Copyright (c) 2011 Crohn's & Colitis Foundation of America, Inc.

Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. [2011.09]
OBJECTIVES: To evaluate the ability of tacrolimus to reduce the corticosteroid dose in patients with myasthenia gravis (MG) and the drug's safety in a double-blind, placebo-controlled, parallel group study... CONCLUSIONS: This study suggests that tacrolimus has a potential advantage as a steroid-sparing agent in the treatment of MG patients. CLINICAL TRIAL REGISTRATION NUMBER: NCT00309088. Name of the trial registry: FK506 Phase 3 Study: A Study for Steroid Non-Resistant MG Patients.

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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: 2013-02-10

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