Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
Drug Details
- Generic Name
- Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl
- Brand Names
- ALTUVIIIO
- Application Number
- BLA125771
- Sponsor
- Bioverativ Therapeutics Inc.
- NDC Codes
- 6
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE ALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment & control of bleeding episodes Perioperative management of bleeding ( 1 ) Limitation of Use: ALTUVIIIO is not indicated for the treatment of von Willebrand disease. ( 1 ) Limitation of Use ALTUVIIIO is not indicated for the treatment of von Willebrand disease.