Consensus statementA pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A
References (51)
- et al.
Drug substitution in transplantation: A National Kidney Foundation White Paper
Am J Kidney Dis
(1999) Cyclosporine: The case for expanding bioequivalence criteria to include measures of individual bioequivalence in relevant population subsets
Therapeutic monitoring for cyclosporine: Difficulties in establishing a therapeutic window
Clin Biochem
(1991)- et al.
Generic substitution for cyclosporine: What should we be looking for in new formulations?
- et al.
Bioequivalence criteria for cyclosporine
- et al.
Differences in bioavailability between oral cyclosporine formulations in maintenance renal transplant patients
Am J Kidney Dis
(1999) British National Formulary 41
(March 2001)Substitution of Critical Dose Drugs: Issues, Analysis and Decision Making
(2000)- et al.
Cyclosporine pharmacokinetics and variability from a microemulsion formulation—a multicenter investigation in kidney transplant patients
Transplantation
(1994) - et al.
Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplanation
Clin Pharmacol Ther
(1993)
Variable oral absorption of cyclosporine. A biopharmaceutical risk factor for chronic renal allograft rejection
Transplantation
Challenges in cyclosporine therapy: The role of therapeutic monitoring by area under the curve monitoring
Ther Drug Monit
Critical therapeutic categories: A contraindication to generic substitution?
Clin Ther
Approved Drug Products with Therapeutic Equivalence Evaluations
Simple bioequivalence criteria: Are they relevant to critical dose drugs? Experience gained from cyclosporine
Ther Drug Monit
Cyclosporine kinetics in healthy volunteers
J Clin Pharmacol
Cyclosporin pharmacokinetics in paediatric transplant recipients
Clin Pharmacokinet
Pharmacokinetics of an oral solution of the microemulsion formulation of cyclosporine in maintenance pediatric liver transplant recipients
Transplantation
Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations
The adverse impact of high cyclosporine clearance rates on the incidences of acute rejection and graft loss
Transplantation
Cyclosporine bioavailability in heart-lung transplant candidates with cystic fibrosis
Transplantation
Altered pharmacokinetics of cyclosporin in heart-lung transplant recipients with cystic fibrosis
Ther Drug Monit
Reduced inter- and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting, low-fat meals, or high-fat meals
Transplantation
Comparison of microemulsion and conventional formulations of cyclosporine A in preventing acute rejection in de novo kidney transplant patients
Transplantation
Cited by (69)
Oral drug delivery strategies for development of poorly water soluble drugs in paediatric patient population
2022, Advanced Drug Delivery ReviewsCitation Excerpt :Neoral® was shown to outperform the marketed SEDDS formulation (Sandimmune®). Several studies have compared safety and efficacy between conventional cyclosporine and microemulsified cyclosporine in children with nephrotic syndrome [127–129] and recipients of renal transplants [130,131]. These studies indicate that there may be considerable differences in CsA exposure when different formulations are administered.
Generics: Are all immunosuppression agents created equally?
2015, Surgery (United States)Cardiovascular events in patients with systemic lupus erythematosus
2014, Cor et VasaCitation Excerpt :Metabolic effects comprising glucose tolerance impairment are described in about 5% of patients treated with cyclosporine A, this drug also being responsible for arterial hypertension or its acceleration. Some 1–10% of patients using cyclosporine A will suffer a myocardial infarction [22]. Cyclophosphamide and methotrexate are – in about 1% of cases – associated with veno-occlusive thromboembolic events concerning mostly peripheral vessels and with myocardial infarctions.
Safety and efficacy of generic cyclosporine arpimune in Filipino low-risk primary kidney transplant recipients
2012, Transplantation ProceedingsImmunophilin-loaded erythrocytes as a new delivery strategy for immunosuppressive drugs
2011, Journal of Controlled ReleaseCitation Excerpt :Since it was introduced in the first 1980s, cyclosporine A has improved the outcome of solid organ transplantation. Unfortunately, CsA is characterised by high intra- and inter-patient pharmacokinetic variability and poor bioavailability [3–5]. Furthermore, the tolerability profile of cyclosporine is characterised by a number of potentially serious adverse effects that are related to exposure, including acute or chronic nephrotoxicity, hypertension and neurotoxicity [6].