Wyeth Pharmaceuticals, a division of Wyeth has announced that the US Food and Drug Administration (FDA) has approved new dosing recommendations for its immunosuppressant drug Rapamune (sirolimus).
Rapamune is the first and only kidney transplant therapeutic with dosing recommendations specifically for the treatment of high immunologic risk renal transplant recipients.
In high immunologic risk patients, it is recommended that a Rapamune-based regimen be used in combination with cyclosporine (CsA) and corticosteroids for the first year following transplantation. The new dosing recommendations for Rapamune also allow for use in combination with antibody induction therapy in this population. High immunologic risk patients have a greater likelihood of developing acute rejection than low to moderate risk kidney transplant recipients.
High immunologic risk patients are defined as transplant recipients who are Black; and/or repeat renal transplant recipients who lost a previous kidney transplant for immunologic reasons; and/or patients with high-panel reactive antibodies (PRA). For patients with high PRA, it is more difficult to find a compatible organ donor.
"Preventing acute rejection is the highest priority for both physicians and their patients during the first year following kidney transplantation. The new labelling for Rapamune is significant because it provides a needed treatment option for high immunologic risk renal transplant recipients," says John F Neylan, M.D., Vice President, Clinical Research and Development, Transplant Immunology/Internal Medicine of Wyeth Pharmaceuticals. "Wyeth remains committed to improving outcomes in renal transplant patients."
In the clinical trial of high immunologic risk patients, patient survival at 12 months was 94.6 per cent. The incidence of biopsy-confirmed acute rejection (BCAR) was 17.4 per cent during the first 12 months post-transplant, and the majority of the episodes of acute rejection were mild in severity. Of those receiving Rapamune plus CsA in the trial, 88.4 per cent also received antibody induction therapy. The safety and efficacy of this combination in high risk patients has not been studied beyond one year.
After the first year following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient.
"There are many barriers to successful kidney transplantation for Black and repeat recipients," says Joe Vassalotti, MD, the National Kidney Foundation's chief medical officer. "The Foundation believes that it is extremely important to have options in preventing and treating acute rejection for these high risk patients."