Results of post-marketing surveillance for Japanese kidney transplant patients using everolimus (Certican^®)

Abstract

In accordance with the GPSP ordinance of the Ministry of Health, Labor and Welfare, a special drug use surveillance (2-year observation period) was conducted to evaluate the safety and efficacy of everolimus (Brand name: Certican) in kidney transplant patients in real-world setting. Finalized observational data from 315 patients were analyzed. The mean age was 49.0 years and the median time after the transplantation to the start of the drug treatment was 11.0 months. The incidence of adverse drug reactions (ADRs; disorders, symptoms, and abnormal laboratory findings for which a causal relationship to the drug cannot be ruled out) was 53.02% (167/315 patients). ADRs with an incidence of ≥5% were stomatitis, hyperlipidemia and proteinuria. ADRs such as stomatitis, hyperlipidemia and edema peripheral, mostly occurred within 3 months after the start of the drug treatment (28.89%, 91/315 patients). Patient- and graft-survival rates were 99.05% and 98.1%, respectively. Rejection rate was 7.94%. The safety and efficacy results of this surveillance showed no additional newly identified concern in the treatment of Japanese kidney transplant patients with everolimus in clinical practice.