Interactions : אינטראקציות

4.5 Interaction with other medicinal products and other forms of interaction

Because basiliximab is an immunoglobulin, no metabolic drug-drug interactions are to be expected.
In addition to ciclosporin for microemulsion, steroids, azathioprine and mycophenolate mofetil, other concomitant medications routinely administered in organ transplantation have been administered in clinical trials without any incremental adverse reactions. These concomitant medications include systemic antiviral, antibacterial and antimycotic medications, analgesics, antihypertensive medications such as beta-blocking agents or calcium channel blockers, and diuretics.

Human antimurine antibody (HAMA) responses were reported in a clinical trial of 172 patients treated with basiliximab, without predictive value for clinical tolerability. The incidence was 2/138 in patients not exposed to muromonab-CD3 (OKT3) and 4/34 in patients who received muromonab-CD3 concomitantly. The use of basiliximab does not preclude subsequent treatment with murine antilymphocyte antibody preparations.

In the original phase III studies during the first 3 months post-transplantation, 14% of patients in the basiliximab group and 27% of patients in the placebo group had an acute rejection episode treated with antibody therapy (OKT 3 or antithymocyte globulin/antilymphocyte globulin [ATG/ALG]), with no increase in adverse events or infections in the basiliximab group as compared to placebo.

Three clinical trials have investigated basiliximab use in combination with a triple therapy regimen which included either azathioprine or mycophenolate mofetil. The total body clearance of basiliximab was reduced by an average 22% when azathioprine was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids. The total body clearance of basiliximab was reduced by an average 51% when mycophenolate mofetil was added to a regimen consisting of ciclosporin for microemulsion and corticosteroids. The use of basiliximab in a triple therapy regimen including azathioprine or mycophenolate mofetil did not increase adverse events or infections in the basiliximab group as compared to placebo (see section 4.8).