Hemlibra

Product Specs	Description
Manufacturer Name	Genentech
Indications	HEMLIBRA is a bispecific factor IXa- and factor X directed antibody. HEMLIBRA is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.
Contraindications	None known
Viral Safety Process	Chromatography steps and additional steps for removal and inactivation of potential viral contaminants.
Product Half-Life	Terminal* Half-life (± SD) 645.6 ± 218.4 hours (26.9 ± 9.1 days)
Manufacturing Method	Emicizumab is produced using a suspension-adapted Chinese Hamster Ovary (CHO) cell line.
Storage Requirements/Shelf Life	Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Prior to administration, if needed, unopened vials may be stored out of and then returned to refrigeration. The temperature and total combined time out of refrigeration should not exceed 30°C (86°F) and 7 days (at a temperature below 30°C [86°F]), respectively.
Nominal Vial Size & Diluent Volume	30 mg/1 mL, 60 mg/0.4 mL, 105 mg/0.7 mL, or 150 mg/1 mL
Route of Administration	Subcutaneous Injection

*Note: Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. (Toutain PL, et al. J Vet Pharmacoll Ther. 2004.)