The role of generics in transplantation

Masri, Marwan; Andrýsek, Tomáš; Matha, V.

doi:10.1016/j.transproceed.2003.09.049

Cited by 7 publications

(4 citation statements)

References 8 publications

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“…Several bioequivalence studies with a total of 278 healthy volunteers and one pharmacokinetic conversion study with 70 stable adult renal transplant recipients were performed to compare the brand leader Neoral ® with Equoral ® . The results of these studies are converted to bioequivalence criteria and they have demonstrated that both drugs, Equoral ® and Neoral ® are bioequivalent and interchangeable in stable renal transplant recipients [5][6][7] . This study presents our experience in de novo renal transplantation in terms of the safety and efficacy of Equoral ® that was used as part of a triple-drug regimen.…”

Section: Introductionmentioning

confidence: 99%

Use of EQUORAL<sup>®</sup> in de novo renal transplant recipients

Zadrazil¹,

Jabry²,

Bachleda³

et al. 2004

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This paper presents our experience to date with using a cyclosporine formulation Equoral (IVAX Pharmaceuticals) together with mycophenolate mofetil plus a steroid immunosuppressive regimen in the treatment of de novo renal transplant recipients. Ten cadaveric donor renal transplant recipients of mean age 51.6 years (range 37-66) were followed up over 6 months for the development of rejection attacks and side effects. All patients received prednisolone, mycophenolate mofetil (1 g/day during the first 5 days posttransplant and then 20 mg/kg/day) plus cyclosporine (3 mg/kg/day). Biopsy proven acute rejection episodes were observed in 2 out of 10 patients (20%). Six months patient as well as renal graft survival rate was 100%. The development of graft function was immediate after transplantation. The mean serum creatinine levels were gradually decreased. Over the 6-month posttransplant period, the function of the graft was satisfactory and stable. The majority of observed adverse events were those commonly reported with the use of cyclosporine and they resolved with a reduction in cyclosporine dose. Equoral treatment demonstrated an acceptable safety profile with maintenance of adequate renal function without incidence of malignancy/lymphoproliferative disease or serious infections. In conclusion, Equoral plus mycophenolate mofetil immunosuppression seems effective and safe on terms acute rejection rates, patient and renal graft survival rates and side profiles.

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Section: Introductionmentioning

confidence: 99%

Use of EQUORAL<sup>®</sup> in de novo renal transplant recipients

Zadrazil¹,

Jabry²,

Bachleda³

et al. 2004

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“…Equoral (Teva Pharmaceuticals) is one such hgCsA microemulsified formulation. Studies comparing the bioequivalence and pharmacokinetic conversion of Neoral with that of Equoral have demonstrated that these drugs are bioequivalent and interchangeable in stable human patients (Andrysek and others 2003, Masri and others 2003, 2004). The effects of Equoral in the management of canine atopic dermatitis have not been reported.…”

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confidence: 99%

Evaluation of a human generic formulation of ciclosporin in the treatment of canine atopic dermatitis with in vitro assessment of the functional capacity of phagocytic cells

et al. 2011

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To compare the efficacy, tolerability and safety of a generic formulation of ciclosporin for human beings with prednisone in the treatment of canine atopic dermatitis), human generic ciclosporin A (hgCsA) (5 mg/kg daily) and prednisone (1 mg/kg daily for seven days, followed by 1 mg/kg every second day) were administered to 13 and seven dogs with atopic dermatitis, respectively, for 42 days. Skin changes were assessed using a modified canine atopic dermatitis extent and severity index (mCADESI-01) and a pruritus intensity scale system. The in vitro functional capacity of phagocytic cells was assessed using the tetrazolium reductase activity and zymosan-stimulated tetrazolium reductase activity tests, as well as measurements of the percentage phagocytic activity and the ingestion capacity of phagocytic cells. Haematological and biochemical parameters were also monitored. There was a greater than or equal to 50 per cent reduction from the baseline in mCADESI-01 scores in 84.6 and 100 per cent of dogs, and a greater than or equal to 50 per cent reduction from the baseline in pruritus scores in 76.9 and 85.7 per cent of dogs, treated with hgCsA and prednisone, respectively. No important adverse physical, haematological or biochemical effects occurred with either drug and no statistically significant changes were detected in any of the four tests assessing the functional activity of phagocytes. The generic formulation of ciclosporin was effective in reducing the severity of physical signs of canine atopic dermatitis and was well tolerated.

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“…Recently, Equoral ® (IVAX, Miami, Fla, USA), a new formulation of CyA, was tested in a bioequivalence study after single dose administration in healthy volunteers. Equoral ® proved to be bioequivalent to Neoral ® (Novartis, Basle, Switzerland) with respect to the extent and the rate of absorption and the drug was marketed 6 . However, standard bioequivalence criteria do not address differences in CyA pharmacokinetics between transplant recipients and healthy volunteers.…”

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confidence: 99%

Pharmacokinetic Conversion Study of a New Cyclosporine Formulation in Stable Adult Renal Transplant Recipients

Perlı́k¹,

Masri²,

Rost³

et al. 2005

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Cyclosporine A (CyA) is a standard component of immunosuppressive regimens. It is a critical-dose drug for which a minor change in absorption can have important clinical consequences. The aim of the study was to compare the pharmacokinetics and safety of the new generic CyA formulation, Equoral ® capsules, after a switch from original formulation, Neoral ® capsules, in seventy stable adult renal transplant recipients. The extent and rate of pharmacokinetic parameters for bioequivalence were compared in a non-randomized, steady-state clinical study with fixed non-replicate study design. Pharmacokinetic analysis of CyA have shown that both the rate and extent of absorption of Equoral ® does not differ significantly from that of Neoral ® . At identical dosing, the new formulation was found to have geometric means of C max 717 ng/ml and AUCτ 3108 ng/ml.h, while corresponding results of comparator were 725 ng/ml and AUCτ 3039 ng/ml.h, respectively. The 90 % confidence intervals of C max and AUCτ were within 80-125 % interval of the mean values. The results suggest that Equoral ® capsules can be used as an alternative treatment to Neoral ® capsules in CyA regimen.

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The role of generics in transplantation

Cited by 7 publications

References 8 publications

Use of EQUORAL<sup>®</sup> in de novo renal transplant recipients

Use of EQUORAL<sup>®</sup> in de novo renal transplant recipients

Evaluation of a human generic formulation of ciclosporin in the treatment of canine atopic dermatitis with in vitro assessment of the functional capacity of phagocytic cells

Pharmacokinetic Conversion Study of a New Cyclosporine Formulation in Stable Adult Renal Transplant Recipients

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