The European Medicines Agency (EMA) in coordination with The Federal Institute for Drugs and Medical Devices (BfArM) has raised concerns regarding Caspofungin containing products, after finding that patients treated with Caspofungin who undergo continuous renal replacement therapy (CRRT) made of polyacrylonitrile (PAN)-based membranes should be avoided as it decreases effectiveness of medication.
This has resulted in increased risk of failure of antifungal treatment leading to worsening of systemic infection potentially result in death of patients. This was based on reports & invitro studies performed that showed recurrence of candidemia upon initiation, and remission upon discontinuation, of CRRT with a PAN filter membrane, as well as four fatal cases where Caspofungin was ineffective in patients undergoing CRRT with the same membrane type & Two in vitro studies indicated adsorption of Caspofungin by PAN membranes. The sequestration persisted even after increasing the Caspofungin dose.
Hence, it is recommended to use an alternative extracorporeal membrane or an alternative antifungal agent.
Caspofungin is a sterile, lyophilized antifungal agent for intravenous infusion, indicated for the treatment of invasive fungal infections in adults and pediatric patients, as well as for empirical therapy in febrile neutropenic patients with suspected fungal infections.
Reporting suspected adverse reactions after authorization is of great importance, as it enables continuous monitoring of the benefit-risk balance of the medicinal product.
Healthcare professionals are requested to report any suspected adverse reactions, lack of efficacy, or product quality complaints related to Caspofungin, including the batch/lot number and the type of membrane used during CRRT, to the marketing authorization holder or its local representative.
