Storage Enhancements for BeneFIX
Horizons in Hemophilia, November 2011
By Leigh Carpenter, RPh, Director of Pharmacy
Pfizer has announced enhanced room temperature storage for BeneFIX. This recombinant factor IX product has now been approved by the FDA to be stored at room temperature (up to 86 degrees Fahrenheit) for up to two years. Previously, the product could only be stored at room temperature for six months.
Studies were done on BeneFIX which showed it to be stable at room temperature for up to two years. The data obtained from these studies was submitted to the FDA and they approved the label change, which previously stated that BeneFIX could only be stored at room temperature for six months. The formulation for BeneFIX remains the same. Room temperature storage enhancements will provide an added convenience to many patients. The outer packaging has been updated to reflect this change. You may also continue to store BeneFIX under refrigeration (not below 36 degrees F).
All doses are now available, which include 250IU, 500IU, 1000IU and 2000IU. Both HoG and Beacon pharmacies still have some of the six month room temperature storage BeneFIX in stock. When this supply has been depleted, the new product with the two year expiration will be available exclusively. There is no problem with using the two different products together for one dose. If you have any questions about this change to BeneFIX, please call the pharmacy.