Drug updated on 4/16/2024
| Dosage Form | Capsule (oral: 0.5 mg, 1 mg, 5 mg) Injection (intravenous: 5mg/mL) Granule (oral: 0.2 mg (1 mg)) |
| Drug Class | Calcineurin inhibitor immunosuppressants |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.
Summary
- Tacrolimus (Prograf) is an immunosuppressant drug used for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants.
- In a meta-analysis involving idiopathic membranous nephropathy (IMN) patients, tacrolimus combined with corticosteroids showed significant therapeutic effect within 1-year treatment especially in the first 6 months but did not have an advantage in longer-term treatments. However, it was associated with higher risk of hand tremor, nephrotoxicity and glucose intolerance compared to control treatment.
- Another study found that tacrolimus monotherapy had comparable efficacy to cyclophosphamide-corticosteroid combination therapy for renal remission in IMN patients; however it resulted fewer drug-related adverse effects despite having a slightly higher relapse rate which was statistically insignificant.
- A systematic review on rheumatoid arthritis (RA) management revealed that tacrolimus is effective with acceptable safety profile when used as part of RA management protocol.
- Nine Systematic Reviews / Meta-Analyses were analyzed overall providing insights into the use of Prograf across different patient populations including those undergoing transplantation procedures as well as those suffering from conditions like IMN and RA.
- Genetic profiling studies suggest defining genetic profiles can help predict individual required dose more rapidly before beginning treatment thus reducing over/underdose period at initial days post-transplantation among pediatric transplant recipients expressing CYP3A5*1 genotype who require higher doses than non-expressers to achieve similar blood levels of Tacrolimus(Prograf).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Prograf (tacrolimus) prescribing information. | 2022 | Astellas Pharma US, Inc. Northbrook, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| English version of clinical practice guidelines for the management of atopic dermatitis 2021. | 2022 | Japanese Dermatological Association: The Journal of Dermatology |
| Clinical practice guidelines for the management of atopic dermatitis 2018. | 2019 | Japanese Dermatological Association: The Journal of Dermatology |
| Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. | 2018 | Journal of the European Academy of dermatology & Venerology |