Cyclosporine microemulsion formulation (neoral) in transplantation: pharmacokinetic/pharmacodynamic relationships

Mueller, Edgar A.; Niese, D.; Mellein, B.

doi:10.1016/s0041-1345(98)00396-0

Cited by 7 publications

(6 citation statements)

References 23 publications

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“…[2] Neoral (Novartis, Switzerland) is a microemulsion formulation with minimum intrapatient and interpatient pharmacokinetic variability[3] notwithstanding its prohibitive costs as per our economic standards.…”

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confidence: 99%

Clinical evaluation of efficacy and safety of cyclosporine (Imusporin) in renal transplant patients with stable graft function maintained on neoral or bioral

Jha¹,

Srivastava²,

Dubey³

et al. 2007

Indian J Urol

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Objective:Previous pharmacokinetic studies have demonstrated bioequivalence of Imusporin (microemulsion preparation of cyclosporine, Cipla) to the innovator product Neoral (Novartis, Switzerland). This study was done to evaluate the clinical efficacy and safety of Imusporin in patients who have already undergone renal transplant and have stable graft function maintained on cyclosporine preparation other than Imusporin.Materials and Methods:Twenty-two renal allograft recipients (mean age of 31.77 years, range 18-53 years), with stable graft function, previously on Neoral or Bioral were switched over to Imusporin after recording their relevant baseline clinical and biochemical parameters. These were repeated on 1, 4, 7, 15, 30 and 90 days after the start of therapy. Change in dosage required to maintain C2 levels at each visit were analyzed by paired sample t-test. Safety of the drug was assessed by the type and severity of adverse events developed during the therapy. Cost analysis was done assuming an average maintenance immunosuppression dose of 150 mg/day of cyclosporine.Results:Twenty-one patients completed the study. One patient was lost to follow-up. Mean C2 value before switchover was 894 ± 208 ng/ml, which was not significantly different from the mean values of C2 after switchover therapy (P>0.30). Change in dosage required to maintain C2 levels was not significantly different from the baseline dose of 2.34 mg/ kg body weight (P>0.1). No patient developed graft rejection after switchover therapy at a median follow-up of 16 months (14-18 months). Mean baseline SCr was similar to SCr at day 90 (1.38 vs. 1.37 mg/dl, P=0.930). No severe adverse events were reported. Mild side-effects included headache (4), somnolence (2), dry mouth (5) and generalized fatigue (6). Use of Imusporin (Cipla, India) results in an annual savings of Rs. 19892 over Neoral (Novartis, Switzerland) and Rs. 2263 over Bioral (Panacea Biotech, India).Conclusions:Imusporin is clinically as safe and efficacious as other cyclosporine preparations available while significantly reducing the cost of treatment.

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confidence: 99%

Clinical evaluation of efficacy and safety of cyclosporine (Imusporin) in renal transplant patients with stable graft function maintained on neoral or bioral

Jha¹,

Srivastava²,

Dubey³

et al. 2007

Indian J Urol

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“…Many of the liver injuries occurring at an early stage after kidney transplantation are drug-induced [10]. The pathogenic mechanism of liver injuries caused by CHB involves suppression of the patient’s immunity by immunosuppressants and active HBV replication [11].…”

Section: Discussionmentioning

confidence: 99%

Effect of Bicyclol tablets on drug induced liver injuries after kidney transplantation

et al. 2017

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AbstractLiver injury is one of the most common complications in patients after kidney transplantation. Bicyclol tablets possess obvious anti-inflammatory and liver-protective functions. This study aimed to explore the clinical effect of preventive application of Bicyclol on drug induced liver injuries at an early stage after kidney transplantation.A total of 1600 patients who accepted kidney transplantations at our hospital from January 2009 to May 2015 were enrolled in this study, and divided into the prevention group (Bicyclol) and the control group (no hepatic protectors) based on whether or not hepatic protectors were regularly administered after the operation. The occurrence of liver injuries at an early stage after the operation and their influencing factors were analyzed.Total of 745 cases were included in the final analysis of which 82 developed liver injuries post-operation, with 22 in the prevention group (4.82%) as compared to 60 in the control group (20.76%) (P= 0.001). As compared to the control group, OR (95% CI) of the prevention group was 0.197 (0.116, 0.334) after revising HBsAg status, age and maintenance immunosuppression.Prophylactic application of Bicyclol as liver-protective treatment was a protective factor against drug induced liver injuries at an early stage after kidney transplantation.

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“…Interestingly, the incidence of double peaks was found to be dramatically reduced at lower doses for the Neoral formulation compared to Sandimmune (27). Several studies have also shown that C max , t max , and AUC for CsA after Neoral oral administration are subject to less variability than with the Sandimmune oral formulation (28). The absorption of CsA from Neoral oral formulations in eleven de novo liver transplant patients was found to be unaffected by T-tube diversion of bile.…”

Section: Sandimmune Oral Csa Formulation Vs Neoral Oral Csa Formulationmentioning

confidence: 98%

“…The expectation of more consistent and superior clinical benefits from Neoral oral formulations based on its superior pharmacokinetics have been confirmed in several studies. Thus, in renal transplantation, significant reductions in the incidence of acute rejection (p ‫ס‬ 0.016), multiple rejection, treatment failure in adult recipients (p ‫ס‬ 0.02), and in the incidence of chronic rejection in pediatric recipients (p < 0.05) have been reported (28). More importantly, it was found that there was no increase in the incidence or severity of adverse effects in transplant patients receiving continuous treatment with Neoral for 2 years (28).…”

Section: Sandimmune Oral Csa Formulation Vs Neoral Oral Csa Formulationmentioning

confidence: 99%

“…Thus, in renal transplantation, significant reductions in the incidence of acute rejection (p ‫ס‬ 0.016), multiple rejection, treatment failure in adult recipients (p ‫ס‬ 0.02), and in the incidence of chronic rejection in pediatric recipients (p < 0.05) have been reported (28). More importantly, it was found that there was no increase in the incidence or severity of adverse effects in transplant patients receiving continuous treatment with Neoral for 2 years (28). The superior absorption of CsA from Neoral oral formulations compared with Sandimmune oral formulations cannot be ascribed to differences in the effects of formulation variables on P-gp efflux mechanisms.…”

Section: Sandimmune Oral Csa Formulation Vs Neoral Oral Csa Formulationmentioning

confidence: 99%

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Chiu

Higaki

Neudeck

et al. 2003

Pharmaceutical Research

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Cyclosporine microemulsion formulation (neoral) in transplantation: pharmacokinetic/pharmacodynamic relationships

Cited by 7 publications

References 23 publications

Clinical evaluation of efficacy and safety of cyclosporine (Imusporin) in renal transplant patients with stable graft function maintained on neoral or bioral

Clinical evaluation of efficacy and safety of cyclosporine (Imusporin) in renal transplant patients with stable graft function maintained on neoral or bioral

Effect of Bicyclol tablets on drug induced liver injuries after kidney transplantation

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