Switchability of Neoral and Equoral According to Food and Drug Administration Rules and Regulations

Masri, Marwan; Haberal, Mehmet; Rizvi, A; Stephan, A; Bi̇lgi̇n, N; Naqvi, Anwar; Barbari, A; Kamel, G; Zafar, N.; Emiroğlu, R; Colak, T.; Manzoor, K.; Matha, V.; Kamarád, V; Rost, M.; Rizk, S; Hazime, A.; Perlı́k, F

doi:10.1016/j.transproceed.2005.07.055

Cited by 11 publications

(11 citation statements)

References 18 publications

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“…Our study supports the role of Equoral as an effective and safe calcineurin inhibitor. These findings are in agreement with those of several other studies that identified good results with Equoral treatment in the prevention of acute rejection and patient and graft survival after renal transplantation 6, 7, 13…”

Section: Discussionsupporting

confidence: 93%

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Zadrazil¹,

Jabry²,

Horák³

et al. 2007

Dialysis & Transplantation

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BACKGROUND Cyclosporin A is a well‐known calcineurin inhibitor that has been used for prophylactic immunosuppression after organ transplantation. The aim of this study was to evaluate the efficacy and safety of a new generic cyclosporin formulation, Equoral (Teva Pharmaceuticals), in the treatment of de novo renal transplant recipients. METHODS Twenty cadaveric‐donor renal transplant recipients between 23 and 71 years of age at the time of transplantation (mean age 52 ± 12.5 years) were followed for 12 months to determine if the grafts functioned and if there were rejection attacks and side effects. In addition to cyclosporin, all patients received mycophenolate mofetil (CellCept) and prednisone (Prednison). RESULTS Mean serum creatinine level decreased significantly after transplantation. In 6 of the 20 patients observed, 7 biopsies showed acute rejection episodes (35%). Over the 12‐month post‐transplant period, all patients showed stable graft function, with a mean serum creatinine level of 202.1 ± 130.9 μmol/L. Patient and renal graft survival rates were 100% after 12 months. Most of the observed adverse events were those commonly reported with the use of cyclosporin, and they resolved with a reduction in the cyclosporin dose. Equoral treatment demonstrated an acceptable safety profile with maintenance of satisfactory and stable renal function. CONCLUSIONS Equoral as a primary immunosuppressant for de novo kidney transplant recipients seems effective and safe in terms of acute rejection rate, patient and renal graft survival rates, and side effect profiles.

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Section: Discussionsupporting

confidence: 93%

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Zadrazil¹,

Jabry²,

Horák³

et al. 2007

Dialysis & Transplantation

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“…However, the experimental setting of the study and the test medication were not precisely described, and the result of the bioequivalence test was not provided. Similar limitations are also applicable to a more recent review on the bioequivalence of Neoral and Equoral (Masri et al 2005). However, unpublished studies (data on file, Equoral product monograph, Ivax) have demonstrated bioequivalence between Equoral and Neoral after fasting administration evaluating data from 36 volunteers as well as after a fat-rich meal using 17 subjects.…”

Section: Discussionmentioning

confidence: 79%

“…However, pharmacokinetic studies in patients imply other drawbacks, such as the need of more subjects, due to the heterogeneity of the study population or ethical problems if one group is possibly not adequately medicated. In a 4-week, multicenter, multinational pharmacokinetic study in 70 patients of different ethnic groups (30 Asian and 40 whites), bioequivalence has been concluded, as no significant differences were found between the pharmacokinetics of Neoral and Equoral (Masri et al 2005). Nevertheless, significant differences in a subgroup of patients could have been ignored just because of the heterogeneity of the study population.…”

Section: Discussionmentioning

confidence: 99%

Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of Neoimmun

Kees

Bucher

Schweda

et al. 2007

Naunyn-Schmied Arch Pharmacol

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In two crossover studies with 12 (6 males/6 females) healthy young volunteers each, we compared the bioavailability of Neoimmun capsules with the microemulsion Neoral and the influence of a fat-rich breakfast on the bioavailability of Neoimmun. Each volunteer received a single dose of 200 mg cyclosporine A in each period. Blood samples were taken up to 24 h and analysed for cyclosporine A by high-performance liquid chromatography (HPLC) and photometric detection. The pharmacokinetic parameters were determined by non-compartmental analysis. The treatments were tested for bioequivalence and significant differences. The bioavailability of Neoimmun was significantly lower compared to Neoral, albeit Neoimmun met the bioequivalence criterion (90% confidence interval of AUC 0.80-0.94) or missed the criterion only marginally (90% confidence interval of c max 0.75-0.91). The bioavailability of Neoimmun as determined by area under the blood concentration-time curve (AUC) increased by nearly 20% after a fat-rich breakfast. However, mean peak concentrations after food were only higher in male subjects, whereas mean peak concentrations in female subjects were lower compared to fasting administration. In conclusion, our data show that Neoimmun exhibits a lower bioavailability than the microemulsion Neoral and that food has a significant but variable and sex-dependent impact on the bioavailability of Neoimmun capsules.

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“…The incidence of biopsy proven acute rejections at 6 months in de novo adult kidney transplant recipients was found significantly higher in patients who received Gengraf ® (Abbott) compared with those who received Neoral ® [5]. On the other hand, a few studies in stable [6–8] and the only one in de novo kidney transplant recipients [9] showed that Equoral ® (Ivax, Opava, Czech Republic) could be used as an alternative treatment to Neoral ® . Thus, more research and more accurate bioequivalence tests are required to address the unanswered problems dealing with the generic CsA formulations.…”

Section: Patient Demographics and Transplant Clinical Datamentioning

confidence: 99%

Do we have the same clinical results with Neoral^®and Equoral^®treatment in kidney transplant recipients? A pilot study

Spasovski¹,

Masin-Spasovska²,

Ivanovski³

2008

Transplant International

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Switchability of Neoral and Equoral According to Food and Drug Administration Rules and Regulations

Cited by 11 publications

References 18 publications

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of Neoimmun

Do we have the same clinical results with Neoral^®and Equoral^®treatment in kidney transplant recipients? A pilot study

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Switchability of Neoral and Equoral According to Food and Drug Administration Rules and Regulations

Cited by 11 publications

References 18 publications

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Efficacy of Equoral in Prophylactic Immunosuppression after De Novo Kidney Transplantation

Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of Neoimmun

Do we have the same clinical results with Neoral®and Equoral®treatment in kidney transplant recipients? A pilot study

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Product

Resources

About

Do we have the same clinical results with Neoral^®and Equoral^®treatment in kidney transplant recipients? A pilot study