| Product Specs | Description |
|---|
| 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 |
