Generic Tacrolimus (Pan Graf) in Renal Transplantation: An Experience of 155 Recipients in India

Guleria, Sandeep; Kamboj, Mini; Chatterjee, Aparna; Sharma, Manju; Awasthy, V.; Dinda, Amit Kumar; Mahajan, Sandeep; Bhowmik, D; Gupta, Satish Chand; Agarwal, Sanjay Kumar; Sc, Tiwari

doi:10.1016/j.transproceed.2008.07.084

Cited by 19 publications

(11 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In many countries, however, generic formulations have been available for over 10 years and their efficacy has been established in real‐life situations. Head‐to‐head data comparing efficacy and toxicity are generally not available for most generics (79–81). Caution should therefore be exercised in choosing a generic formulation for use in KTRs.…”

Section: Rationalementioning

confidence: 99%

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

Eckardt¹,

Kasiske²,

Zeier³

2009

American Journal of Transplantation

1,205

294

View full text Add to dashboard Cite

Journal compilation © 2009 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/j.1600-6143.2009.02834.x S2 American Journal of Transplantation 2009; 9 (Suppl 3): S2-S2Since the first successful kidney transplantation in 1954 It is our hope that this document will serve several useful purposes. Our primary goal is to improve patient care. We hope to accomplish this in the short term by helping clinicians know and better understand the evidence (or lack of evidence) that determines current practice. By making this guideline broadly applicable, our purpose is to also encourage and enable the establishment and development of transplant programs worldwide. Finally, by providing comprehensive evidence-based recommendations, this guideline will also help define areas where evidence is lacking and research is needed. Helping to define a research agenda is an often neglected, but very important function of clinical practice guideline development.We used the GRADE system to rate the strength of evidence and the strength of recommendations. In all, there were only 4 (2%) recommendations in this guideline for which the overall quality of evidence was graded 'A,' whereas 27 (13.6%) were graded 'B,' 77 (38.9%) were graded 'C,' and 90 (45.5%) ' and 148 (74.7%) graded '2.' There were 3 (1.5%) recommendations graded '1A,' 16 (8.1%) were '1B,' 18 (9.1%) were '1C, ' and 13 (6.6%) were '1D.' There was 1 (0.5%) graded '2A,' 11 (5.6%) were '2B,' 59 (29.8%) were '2C, ' and 77 (38.9%) BackgroundExcept perhaps for transplantation between identical twins, all kidney transplant recipients (KTRs) need immunosuppressive medications to prevent rejection. Induction therapy is treatment with a biologic agent, either a lymphocyte-depleting agent or an interleukin 2 receptor antagonist (IL2-RA), begun before, at the time of, or immediately after transplantation. The purpose of induction therapy is to deplete or modulate T-cell responses at the time of antigen presentation. Induction therapy is intended to improve the efficacy of immunosuppression by reducing acute rejection, or by allowing a reduction of other components of the regimen, such as calcineurin inhibitors (CNIs) or corticosteroids. Available lymphocytedepleting agents include antithymocyte globulin (ATG), antilymphocyte globulin (ALG) and monomurab-CD3. Basiliximab and daclizumab, the two IL2-RAs that are currently available in many parts of the world, bind the CD25 antigen (interleukin-2 [IL2] receptor a-chain) at the surface of activated T-lymphocytes and thereby competitively inhibit IL2-mediated lymphocyte activation, a crucial phase in cellular immune response of allograft rejection. Rationale• There is high-quality evidence that the benefits of IL2-RA vs. no IL2-RA (or placebo) outweigh harm in a broad range of KTRs with variable immunological risk and concomitant immunosuppressive medication regimens.• There is moderate-quality evidence that a lymphocytedepleting agent vs. no lymphocyte-depleting a...

show abstract

Section: Rationalementioning

confidence: 99%

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

Eckardt¹,

Kasiske²,

Zeier³

2009

American Journal of Transplantation

1,205

294

View full text Add to dashboard Cite

show abstract

“…Three studies have evaluated the clinical outcomes of patients receiving generic tacrolimus preparations (including PanGraf ® and Tacro-Bell ® ) and have reported that these medications are safe and effective [4–6]. However, the reliability of these conclusions is undermined by the non-comparative nature of these studies.…”

Section: Introductionmentioning

confidence: 99%

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport^®or Prograf^®preparations of tacrolimus

et al. 2012

View full text Add to dashboard Cite

BackgroundThe use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®.MethodsData regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed.ResultsA total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups.ConclusionsThis is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure.

show abstract

“…Generic tacrolimus has been used in organ transplant practice all over the world for more than ten years. In the prospective study of Guleria (13), generic tacrolimus (PanGraf®) used successfully in 155 de novo kidney transplant recipients. In Kim's multicenter study (14), generic tacrolimus (TacroBell®) found to be effective and safe in de novo kidney transplant recipients.…”

Section: Discussionmentioning

confidence: 99%

Clinical and Safety Outcomes of Conversion Original Tacrolimus to Generic Tacrolimus in Turkish Kidney Transplant Recipients

Günay

2020

Preprint

View full text Add to dashboard Cite

Background After the United States, The Food and Drug Administration approved the use of the first generic of the original tacrolimus in 2009, generic tacrolimus was preferred in many countries for cost-reducing reasons. This is the first study on the conversion of original tacrolimus to the generic tacrolimus, reported from Turkey. Methods The inclusion criteria of this single-center, retrospective study were 1) being ≥18 years old, 2) passing at least three months after kidney transplantation, 3) conversion from reference tacrolimus (Prograf®) to generic tacrolimus (Adoport®). The primary endpoints were acute rejection, an increase in serum creatinine, decreases in e-GFR, tacrolimus level, tacrolimus concentration/dose ratio. We applied the paired T-test to analyze the pre-conversion and final visit laboratory values. Results Thirty-six patients who agreed to use generic tacrolimus evaluated. The mean age was 39.8 years (± 11.6), % 52,7 were female, % 86,1 were living donor transplants. The patients followed up for 12 months (3-41). There was no increase in serum creatinine value, no decreases in e-GFR and tacrolimus concentration/dose ratio. We observed a decrease in tacrolimus level (p=0,037). Decreasing the target value may have caused this result, as there are 9 patients with positive BK-DNA. None of the patients needed a biopsy. Conclusion Based on the results of our study, renal outcomes are safe and the drugs could be changed safely. Whether Prograf® or Adoport®, whichever is used, it is important to continue taking the drug at the recommended dose and time. The physician should be careful in dose adjustment after conversion, especially for those who are in the first year of transplantation.

show abstract

Generic Tacrolimus (Pan Graf) in Renal Transplantation: An Experience of 155 Recipients in India

Cited by 19 publications

References 5 publications

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport^®or Prograf^®preparations of tacrolimus

Clinical and Safety Outcomes of Conversion Original Tacrolimus to Generic Tacrolimus in Turkish Kidney Transplant Recipients

Contact Info

Product

Resources

About

Generic Tacrolimus (Pan Graf) in Renal Transplantation: An Experience of 155 Recipients in India

Cited by 19 publications

References 5 publications

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport®or Prograf®preparations of tacrolimus

Clinical and Safety Outcomes of Conversion Original Tacrolimus to Generic Tacrolimus in Turkish Kidney Transplant Recipients

Contact Info

Product

Resources

About

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport^®or Prograf^®preparations of tacrolimus