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recombinant factor IX Fc fusion protein (Aprolix)
Indications:
- treatment of hemophilia B
Contraindications:
- hypersensitivity to components
Pregnancy category: C
Dosage:
- prophylaxis
- start with at least 1 week between infusions
- minor to moderate bleeding
- every 48 hours as needed
- major bleeding
- consider repeat dose in 6-10 hours, then
- every 24 hours for 3 days, then
- every 48 hours until healing is complete [2]
lyophilized powder in single use vials containing 500, 1000, 2000, or 3000 IU of factor IX
Adverse effects:
- common (> 1%)
- headache, oral paresthesia
General
coagulation factor IX; Christmas factor; plasma thromboplastin component; PTC; contains: coagulation factor IXa light chain; coagulation factor IXa heavy chain (F9)
recombinant protein; chimer
fusion protein
References
- biogen idec. Press Release. March 28, 2014
FDA Approves Biogen Idec's ALPROLIX, the First Hemophilia B
Therapy to Reduce Bleeding Episodes with Prophylactic Infusions
Starting at Least a Week Apart.
http://www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2303&M=NewsV2&PID=61997
- Aprolix Prescribing Information
http://www.alprolix.com/pdfs/PrescribingInformation.pdf