Obizur

Product Specs	Obizur
Manufacturer Name	Takeda
Indications	OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A.
Contraindications	Do not use in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components, including hamster protein.
Manufacturing Methods	Genetically engineered baby hamster kidney (BHK) cell line which secretes rpFVIII into the cell culture medium
Viral Safety Process	Chromatography, solvent/detergent treatment, nanofiltration
Route of Administration	Intravenous
Product Half-Life	Range 2.6 to 28.6 hours
Storage Requirements/Shelf Life	Store at temperatures of 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original package to protect from light. Do not use beyond the expiration date printed on the label. Use within 3 hours after reconstitution. Do not use if the reconstituted solution is cloudy or has particulate matter.
Available Formulations	When reconstituted with the diluent, the product contains the following components per mL: 8.8 mg sodium chloride, 0.04 mg Tris-base, 0.73 mg Tris-HCl, 1.47 mg trisodium citrate dehydrate, 0.15 mg calcium chloride dehydrate, 1.9 mg sucrose, and 0.05 mg polysorbate 80