Product information and disease descriptionPlace of product in therapyApproaches to treatment
Place in treatment, anticipated use, and care setting
1 evidence topic · 13 sources
Summary
The cited European indication concerns highly sensitized adults with a positive crossmatch against an available deceased donor, and European consensus considers imlifidase for selected candidates without other treatment options. The French consensus specifies cPRA of at least 98%, age no greater than 65 years, at least three years on the waiting list, and low biopsy-complication risk; these are consensus selection criteria rather than a universal label restriction. Administration is restricted to hospital use. Crossmatch conversion must be confirmed before transplantation. The French protocol combines imlifidase with additional immunosuppression, and German consensus recommends considering an early protocol biopsy between days 7 and 10 when clinically feasible.