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.
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Prograf (Tacrolimus)
Independent Study Utilizing Cyclic Levulan PDT Finds 95 Percent Reduction In New Squamous Cell Carcinoma Lesions In Solid Organ Transplant Recipients
Source: Dermatology News From Medical News Today [2009.11.11]
The results of an independent investigator study just published in the online version of Dermatologic Surgery demonstrate that Levulan(®) Photodynamic Therapy (PDT) may reduce the rate of recurrence of squamous cell carcinomas (SCCs) in solid organ transplant recipients (SOTRs), a population with a high incidence of nonmelanoma skin cancer.
Published Studies Related to Prograf (Tacrolimus)
UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. [2009.09]
Mycophenolate mofetil (MMF) is an immunosuppressive drug commonly used in the context of kidney transplantation. Exposure to the active metabolite mycophenolic acid (MPA) is associated with risk of allograft rejection... Cyclosporine-treated UGT1A8*2/*2 (518GG) patients had an 18% higher MPA AUC(0-12) compared with noncarriers.
Response of vitiligo to once- vs. twice-daily topical tacrolimus: a controlled prospective, randomized, observer-blinded trial. [2009.08]
BACKGROUND: A few studies on the treatment of vitiligo with topical tacrolimus have been published and showed promising results. However, most of these trials were uncontrolled. OBJECTIVE: This study aims to assess the response of vitiligo to once- or twice-daily treatment with 0.1% tacrolimus in a controlled, randomized, observer-blinded study... CONCLUSIONS: Tacrolimus ointment appears to be an effective treatment option for facial vitiligo. A guarded prognosis is advisable for vitiliginous lesions on other localizations. Treatment must be applied twice daily for optimum response.
Efficacy and safety of tacrolimus versus cyclosporine in children with steroid-resistant nephrotic syndrome: a randomized controlled trial. [2009.05]
BACKGROUND: To examine whether tacrolimus is more effective and safe than cyclosporine (CsA) in inducing remission in patients with steroid-resistant nephrotic syndrome (SRNS)... CONCLUSIONS: Tacrolimus or CsA in combination with low-dose steroids show similar efficacy in inducing remission in patients with SRNS. Therapy with tacrolimus is a promising alternative to CsA in view of the lower risk of relapses and lack of cosmetic side effects.
The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis. [2009.04]
BACKGROUND: In adults and children aged > 2 years, systemic absorption of tacrolimus from tacrolimus ointment is very low. In this study, the pharmacokinetics of tacrolimus 0.03% ointment were investigated in infants aged 3-24 months... CONCLUSIONS: Tacrolimus 0.03% ointment in infants is associated with very low systemic exposure to tacrolimus. Treatment was well tolerated and led to considerable clinical improvement.
Efficacy and safety of tacrolimus ointment 0.1% vs. betamethasone 17-valerate 0.1% in the treatment of chronic paronychia: an unblinded randomized study. [2009.04]
BACKGROUND: Recent studies have established the pivotal role of irritants and allergens in development of chronic paronychia and the significant improvement with corticosteroid therapy. OBJECTIVES: The objective of this randomized, unblinded, comparative study was to compare the efficacy of tacrolimus ointment 0.1% vs. betamethasone 17-valerate 0.1% in the treatment of chronic paronychia... CONCLUSIONS: Tacrolimus ointment appears to be a more efficacious agent than betamethasone 17-valerate or placebo for the treatment of chronic paronychia.
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]
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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Page last updated: 2009-11-11
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