Hemlibra



Hemlibra

Product Specs Hemlibra
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.)


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