A multicenter assessment of recombinant factor VIIa off-label usage: clinical experiences and associated outcomes

BACKGROUND: Off‐label use of recombinant factor VIIa (rFVIIa) occurs despite minimal data. The purpose of this study was to describe prescribing practices and clinical outcomes for off‐label rFVIIa use. STUDY DESIGN AND METHODS: A retrospective, multicenter chart audit of 315 nonhemophiliac patients was performed. RESULTS: Off‐label indications included prevention of bleeding primarily related to procedural manipulation in 37.8 percent of patients and treatment of bleeding in 62.2 percent of patients. Baseline coagulopathy was present in 79.7 percent of patients. Prescriber specialty varied. The median doses for prevention and treatment were 75.6 and 89.4 µg per kg, respectively (p = 0.0006). The international normalized ratio (INR) decreased (p