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
  • Refrigerated at 2°C to 8°C (36°F to 46°F), or at room temperature for up to 7 days, at 30°C (86°F).
  • Do not freeze.
    		•
    Shelf Life 24 months from manufactured date
    7 days at room temperature
    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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