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:
1. Off-Label Use of rFVIIa - P & T Community
2. NovoSeven for Traumatic Coagulopathy - Dr. Karim Brohi at trauma.org
3. 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