Formula & Concentration

  • ROCTAVIAN (valoctocogene roxaparvovec-rvox) suspension for intravenous infusion
  • ROCTAVIAN has a nominal concentration of 2 × 1013 vg valoctocogene roxaparvovec-rvox per mL, each vial contains an extractable volume of not less than 8 mL (16 x 1013 vg)




ROCTAVIAN is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test.

  • This is a one-time therapy

Product Options

Package Size



8 mL (16 x 1013 vg)



Shelf Life and Storage

  • Product as Packaged for Sale
    • Transport frozen at ≤ -60°C (-76°F)
    • Store upright at ≤ -60°C (-76°F)
    • Store ROCTAVIAN vial in carton until ready to use.
    • Protect ROCTAVIAN from light.
  • During Preparation and Administration
    • Thaw at room temperature, up to 25°C (77°F).
    • After thawing, ROCTAVIAN can be held at room temperature for a maximum of 10 hours, including preparation and infusion times.
    • If necessary, an intact vial (stopper not yet punctured) that has been thawed can be stored refrigerated (2 to 8 °C) for up to 3 days, upright and protected from light (e.g., in the original carton).
    • Do not expose ROCTAVIAN to the light of an ultraviolet radiation disinfection lamp.
    • Once thawed, DO NOT REFREEZE.
    • Treat spills of ROCTAVIAN with a virucidal agent with proven activity against non-enveloped viruses and blot using absorbent materials.
    • Dispose of unused product and disposable materials that may have come in contact with ROCTAVIAN in accordance with local guidance for pharmaceutical waste.
  • Dating Period
    • The dating period for valoctocogene roxaparvovec-rvox shall be 36 months from the date of manufacture when stored at -60°C. The date of manufacture shall be defined as the date of final sterile filtration of the formulated drug product. Following the final sterile filtration, no reprocessing/reworking is allowed without prior approval from the Agency. The dating period for your drug substance shall be 12 months when stored at -60°C or 21 days when stored at 2-8° We have approved the stability protocol in your license application for the purpose of extending the expiration dating period of your drug substance and drug product under 21 CFR 601.12