Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A.

ABSTRACT:

Introduction

Antihaemophilic factor (recombinant) (rAHF; ADVATE^® ) is approved for prophylaxis and treatment of bleeding in children and adults with haemophilia A. Reconstitution in 2 mL sterile water for injection instead of 5 mL allows for a 60% reduction in infusion volume and administration time, but could increase the likelihood of hypersensitivity and infusion-related reactions, especially in children.

Aim

To assess local tolerability, safety and effectiveness of rAHF 2 mL during routine clinical practice factor VIII (FVIII) replacement (on-demand and prophylaxis) in children with severe (FVIII < 1%) or moderately severe (FVIII 1%-2%) haemophilia A.

Methods

This was a prospective, non-interventional, postauthorization safety surveillance study (NCT020

SUBMITTER: Motwani J 

PROVIDER: S-EPMC7383916 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature