Novo Nordisk Notice on COVID-19, Rebinyn® and Laboratory Assays

Industry NewsNovo Nordisk recently distributed a notice relevant to its product Rebinyn®, raising awareness that one-stage clotting assay results can be significantly affected by the type of activated partial thromboplastin time (aPTT) reagent used, which can result in over or under-estimation of Factor IX activity.
The notice which was addressed to HTCs, physicians and other healthcare providers, includes a chart encompassing the assays most commonly used to diagnose, monitor, and manage patients with COVID-19-associated coagulopathy, whether these assays are affected by Rebinyn®, and possible alternatives where applicable.
“Avoid the use of silica-based reagents, as some may overestimate the activity of REBINYN®.  If a validated one-stage clotting or chromogenic assay is not available locally, then use of a reference laboratory is recommended. Specifically, Rebinyn®, a modified Factor IX product used for the treatment of haemophilia B, is known to interact with the reagents used for the aPTT analysis causing either erroneous shortening or prolongation of clotting time.”
REBINYN®, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding

View and download the dear healthcare provider letter from Novo Nordisk.
Source: Novo Nordisk, May 18, 2020