Effect of Basiliximab on Renal Allograft Rejection Within 1 Year After Transplantation

Lee, B.M.; Oh, Chang‐Keun; Jin, Sung‐Ho; Kim, J.H.; Kim, S.J.; Kim, H.; Shin, Gyu‐Tae

doi:10.1016/j.transproceed.2006.06.026

Cited by 7 publications

(4 citation statements)

References 12 publications

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“…Research carried out in Chinese patients showed AUC values ranging from 44.40 to 158.01 (μg·h/ml) (average value was 92.23 ± 34.97 (μg·h/ml). The lower values of tacrolimus concentration in the patients of the present study are consequence of applied combined immunosuppressive therapy with monoclonal antibody (Bas), which can be significant in reducing the risk of development of diabetes as a potential complication in tacrolimus therapy [11,13,25–28]. The authors determined that C 5 may be the best indicator to predict AUC [1].…”

Section: Discussionmentioning

confidence: 99%

Clinical Pharmacokinetics of Tacrolimus after the First Oral Administration in Renal Transplant Recipients on Triple Immunosuppressive Therapy

Veličković‐Radovanović

Paunović

Mikov

et al. 2010

Basic Clin Pharma Tox

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Monitoring of tacrolimus blood concentration is of utmost importance in the management of renal transplant recipients because of Narrow Therapeutic Index and highly variable pharmacokinetics. The aim of this study was to detect inter-patient pharmacokinetic variability of tacrolimus and to assess the predictability of individual tacrolimus concentrations at various times of the area under the curve (AUC) seeking to find the best sampling time to predict the exposure of tacrolimus in renal transplant recipients with triple therapy. This oral dose tacrolimus pharmacokinetics study was conducted in 18 Serbian renal transplant recipients on triple immunosuppressive therapy, including basiliximab. The first oral dose of tacrolimus (0.05 mg ⁄ kg) was given on day 5 post-transplant; blood concentration was measured by microparticle enzyme immunoassay method. Associations between each sampling time-point of concentrations and AUC 12 were evaluated by Pearson correlation coefficients. Abbreviated sampling equations were derived by multiple, stepwise regression analyses. The variance in the strength of association between predicted AUC (AUC p ) and AUC 12 was reflected by linear regression coefficients. AUC 12 showed remarkable inter-individual variations after the first oral dose of tacrolimus. The area of the maximum AUC was four times higher than that of the minimum AUC. C 4 seems to be an indicator of total body exposure to tacrolimus. Alternatively, the concentrations at 1.5, 4 and 8 hr as an abbreviated AUC were as good a predictor as a full pharmacokinetic study. Our results show a significant difference between men and women. A three-point sampling method seemed to be the best abbreviated AUC for a cost-effective tacrolimus monitoring strategy.Rejection prophylaxis using calcineurin inhibitors (cyclosporine or tacrolimus) remains the best practice pending publication of long-term results using newer agents [1][2][3]. The choice of cyclosporine or tacrolimus depends on immunological risk, recipient characteristics, concomitant immunosuppression and socio-economic factors. Tacrolimus (FK 506) is superior to cyclosporine in improving graft survival and preventing acute rejection after kidney transplantation, but increases post-transplant diabetes, neurological and gastrointestinal side effects [3,4]. Monitoring of tacrolimus blood concentrations is of utmost importance in the management of renal transplant recipients because of the narrow therapeutic range and highly variable pharmacokinetics of the drug [1][2][3][4]. If the concentration is lower than the range, the transplanted kidney will be rejected because of insufficient immunosuppression by tacrolimus. If the concentration is higher than the range, adverse effects will be observed because of the excess concentration of tacrolimus. High systemic exposure to tacrolimus might induce many side effects including nephrotoxicity, neurotoxicity and post-transplant diabetes mellitus [3,4]. Therapeutic monitoring of tacrolimus plays a crucial role not only in ...

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Section: Discussionmentioning

confidence: 99%

Clinical Pharmacokinetics of Tacrolimus after the First Oral Administration in Renal Transplant Recipients on Triple Immunosuppressive Therapy

Veličković‐Radovanović

Paunović

Mikov

et al. 2010

Basic Clin Pharma Tox

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“…Studies have reported reduced rates of acute rejection with the addition of basiliximab to their immunosuppressant regimens [1,3,[9][10][11][12]. Basiliximab is easy to administer, requiring just two doses on day 0 and day 4 following renal transplantation.…”

Section: Discussionmentioning

confidence: 99%

“…Induction therapy has been utilized since the late 1970s to reorient the immune system at the time of antigen presentation, decrease acute rejection and improve long-term graft survival. Basiliximab is a potent and widely used immunosuppressive induction agent, and its administration as a prophylactic at the time of transplantation has been advocated to improve allograft outcomes [2,3]. Large adult multicenter trials in the USA and Europe have reported that routine basiliximab induction significantly reduces the incidence of acute rejection episodes without significant associated adverse effects [4,5].…”

Section: Introductionmentioning

confidence: 99%

Basiliximab induced non-cardiogenic pulmonary edema in two pediatric renal transplant recipients

et al. 2009

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We report two cases of non-cardiogenic pulmonary edema as a complication of basiliximab induction therapy in young pediatric renal transplant patients identified following a retrospective review of all pediatric renal transplant cases performed in the National Paediatric Transplant Centre, Childrens University Hospital, Temple Street, Dublin, Ireland. Twenty-eight renal transplantations, of which five were living-related (LRD) and 23 were from deceased donors (DD), were performed in 28 children between 2003 and 2006. In six cases, transplantations were pre-emptive. Immunosuppression was induced pre-operatively using a combination of basiliximab, tacrolimus and methylprednisolone in all patients. Basiliximab induction was initiated 2 h prior to surgery in all cases and, in 26 patients, basiliximab was re-administered on post-operative day 4. Two patients, one LRD and one DD, aged 6 and 11 years, respectively, developed acute non-cardiogenic pulmonary edema within 36 h of surgery. Renal dysplasia was identified as the primary etiological factor for renal failure in both cases. Both children required assisted ventilation for between 4 and 6 days. While both grafts had primary function, the DD transplant patient subsequently developed acute tubular necrosis and was eventually lost within 3 weeks due to thrombotic microangiopathy and severe acute antibody-mediated rejection despite adequate immunosuppression. Non-cardiogenic pulmonary edema is a potentially devastating post-operative complication of basiliximab induction therapy in young pediatric patients following renal transplantation. Early recognition and appropriate supportive therapy is vital for patient and, where possible, graft survival.

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“…[60][61][62] For example, during 4 years of follow-up in the largest (n = 253) of these analyses, [62] patients who had received basiliximab combined with triple immunotherapy had a significantly lower acute rejection rate (7.6% vs 24%; p £ 0.001). [60][61][62] For example, during 4 years of follow-up in the largest (n = 253) of these analyses, [62] patients who had received basiliximab combined with triple immunotherapy had a significantly lower acute rejection rate (7.6% vs 24%; p £ 0.001).…”

Section: Long-term Follow-upmentioning

confidence: 97%

Basiliximab

McKeage

McCormack²

2010

BioDrugs

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Basiliximab (Simulect) is a recombinant chimeric murine/human IgG1 monoclonal anti-interleukin-2 receptor antibody that is indicated for the prevention of acute organ rejection in adult and pediatric renal transplant recipients in combination with other immunosuppressive agents. Induction therapy with two doses (day 0 and day 4) of intravenous basiliximab as part of double- or triple-immunotherapy regimens in adult renal transplant recipients reduces acute rejection episodes without increasing the incidence of adverse events. Compared with rabbit-derived antithymocyte globulin (RATG), basiliximab is generally associated with similar efficacy in standard-risk patients, but reduced efficacy in high-risk patients. Initial results indicate that induction with basiliximab is associated with a higher rate of biopsy-proven acute rejection than alemtuzumab induction. Basiliximab is generally associated with a tolerability profile that is similar to that reported with placebo, and better than that reported with RATG. As with other induction agents, basiliximab has not demonstrated improved graft or patient survival over the long term (periods of up to 7 years). Basiliximab induction allows for reduced dosage of corticosteroids or calcineurin inhibitors, while maintaining adequate immunosuppression, thereby reducing the potential for adverse effects associated with these coadministered agents. Thus, basiliximab provides an effective, well tolerated option for the prophylaxis of acute renal transplant rejection.

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Effect of Basiliximab on Renal Allograft Rejection Within 1 Year After Transplantation

Cited by 7 publications

References 12 publications

Clinical Pharmacokinetics of Tacrolimus after the First Oral Administration in Renal Transplant Recipients on Triple Immunosuppressive Therapy

Clinical Pharmacokinetics of Tacrolimus after the First Oral Administration in Renal Transplant Recipients on Triple Immunosuppressive Therapy

Basiliximab induced non-cardiogenic pulmonary edema in two pediatric renal transplant recipients

Basiliximab

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