Basiliximab dosing

The authors of the first study recommend that the initial dose of ciclosporin should be limited to 400 mg/m in children receiving renal transplants who are also given with basiliximab. Dose reductions were not considered necessary by other authors, but close monitoring was recommended. ... 

The dose of basiliximab is 20 mg intravenously (IV) given within 2 hours prior to the transplant, followed by a second 20 mg dose on postoperative day 4.7,9,11 This dosing schedule can be used for both children weighing 35 kg (77 lb) or more and adults. Two 10 mg doses with the same dosing schedule should be used for children weighing less than 35 kg (77 lb). No specific dosage adjustments is needed in renal or hepatic impairment.7,9,11... 

The Food and Drug Administration (FDA) approved dose of daclizumab is 1 mg/kg within 24 hours of transplant surgery and then 1 mg/kg administered every 2 weeks after surgery for a total of five doses.7,9,11 No dose adjustment is necessary in renal impairment, but no data are available for dose adjustments in hepatic dysfunction. Several trials have shown that a shorter dosing regimen of daclizumab, two doses given in a similar manner as basiliximab, may be as safe and effective as the full five-dose course.12,13... 

Basiliximab (Simulect ) 20 mg IV x 2 doses None reported compared with 3,401... 

Pharmacokinetics Complete and consistent blocking of the IL-2 receptor is maintained as long as serum basiliximab levels exceed 0.2pg/ml. As concentrations fall below this level, expression of IL-2 receptor returns to pre-therapy values within 1-2 weeks. Basiliximab has a steady-state volume of distribution of 9 liters and total body clearance of 41 ml/h. Its elimination half-life ranges from 7 to 10 days. There is a dose-proportional increase in peak concentration (Cmax) and area under the curve (AUC) up to the highest tested single dose of 60 mg. No clinically relevant influence of body weight or gender on distribution volume or clearance has been observed in adult patients. Elimination... 

SIMULECT (Basiliximab) [CHO-expressed glycoprotein, chimeric monoclonal Ab IgGl] Novartis Lyophilized 10 mg single-dose vial 20 mg single-dose vial... 

Simulect Basiliximab Chimeric IgGi CD25 Organ transplant IV 20 mg 2 doses (days 1 and 5)... 

A 42-year-old Hispanic woman, with end-stage renal disease, anemia, hypertension, and a history of an anaphylactic reaction to basiliximab, was scheduled to receive a living donor transplant and received basiliximab uneventfully (5). However, owing to donor infection the procedure was cancelled and rescheduled for 2 weeks later. Within 10 minutes after basiliximab reinduction she developed an anaphylactic reaction. In an attempt to find another induction therapy for this patient, skin testing was performed for daclizumab without response. She therefore received full-dose induction with daclizumab before her organ transplant without adverse effect. 

Anti-CD4 (humanized hIgGl-CD4 modulating, non-depleting monoclonal antibody). Anti-CD4 monoclonal antibodies have been used in the treatment of rheumatoid arthritis, psoriasis, systemic lupus erythematosus, and multiple sclerosis. First dose reactions were observed (dyspnea, chills, hypotension [32]. Of note, the anti-IL-2 Receptor (a chain) antibodies dadi-zumab (Zenapax) and basiliximab (Simulect), widely studied in renal transplant recipients, do not induce cytokine release or first dose reactions [33]. 

The concurrent use of basiliximab with azathioprine, muromon-ab-CD3 or mycophenolate is not associated with an increase in adverse effects or infections. The dose requirements of ciclosporin or tacrolimus may be altered by basiliximab. Basiliximab is reported not to interact with analgesics, anti-infective drugs, diuretics, beta blockers or calcium-channel blockers. 

In a randomized, open, single-center study of two monoclonal antibodies to IL-2 receptors combined with triple immunosuppression (ciclosporin microemulsion, mycophenolate mofetil, and methylpredniso-lone), 212 adult recipients of at least 1HLA-mismatched dead donor renal graft were randomized to induction with basiliximab or daclizumab, given in standard doses. Hospital treatment was required in 50 and 59 patients with infections who received basiliximab and daclizumab respectively. There were one case of renal cell carcinoma and one of basal cell carcinoma in the basiliximab group, and one melanoma in the daclizumab group. There was one hypersensitivity reaction with daclizumab [119 ]. 

Observational studies Adverse events have been studied in a 2-year, non-placebo-controlled trial in 164 children and adolescents undergoing renal transplantation [151, who were randomized to tacrolimus, azathioprine, and glucocorticoids or tacrolimus, azathioprine, glucocorticoids, and two doses of basiliximab. Basiliximab conferred no additional benefit. There were no differences between the groups in mean eGFR, blood pressure, or serum cholesterol concentrations, and no differences in the incidences of infections or malignancies. 

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