BeneFIX Storage

Store and transport refrigerated (2°C - 8°C). Freezing should be avoided to prevent damage to theprefilled diluent syringe.
For the purpose of ambulatory use, the product may be removed from refrigerated storage for one single period of storage at or below 30°C for up to 6 month within 36 months. At the end of this period, the product should not be put back in the refrigerator, but should be used or discarded.
Shelf-Life: 3 years.
The reconstituted product should be used immediately, but no longer than 3 hours after reconstitution. Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C. BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX, including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations in Dosage & Administration be followed closely.