Tuesday, October 18, 2005


Tuesday October 18, 2005
Off label use of Novoseven and cost concern

A growing literature suggests that there may be indications for the off label use of NovoSeven
(rFVIIa) like critical coagulopathy; intracerebral hemorrhage; severe liver disease; to achieve hemostasis in acute variceal bleed; high-risk surgeries; blood loss from trauma; platelet disorders etc.

It is important to develop official policy / protocol due to high cost. Cost of single 4.8 mg vial (4800 ug) is about 4-5,000 US dollars. Usual dose is about 90 ug/kg (every 2 hours till hemostasis achieved) !! - Go figure out !!

Click to view FDA Warning letter re. NovoSeven

References: click on link to get article:
Off-Label Use of rFVIIa - P & T Community
NovoSeven for Traumatic Coagulopathy - Dr. Karim Brohi at trauma.org
Novoseven for Acute Intracerebral Hemorrhage - NEJM
4. Efficacy of Novoseven in cirrhotic patients with upper gastrointestinal bleeding: A randomised double-blind trial. J Hepatol. 2003;38 (Suppl 2):13