Hemgenix



Hemgenix

Product Specs Hemgenix
Manufacturer Name CSL Behring
Indications HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:

  • Currently use Factor IX prophylaxis therapy, or
  • Have current or historical life-threatening hemorrhage, or
  • Have repeated, serious spontaneous bleeding episodes.
    		•
    Contraindications None known
    Viral Safety Process HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1).
    Product Half-Life Factor IX activity levels of 39% (± 18.7), 41.5% (± 21.7), 36.9% (± 606 21.4) and 36.7 (± 19.0) of normal, respectively, at 6, 12, 18 and 24 months.
    Manufacturing Method
    Storage Requirements Before Dilution

  • HEMGENIX is shipped at 2°C to 8°C (36°F to 46°F).
  • Upon receipt, store HEMGENIX vials in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • Store HEMGENIX in the original carton until use.
  • Protect HEMGENIX from light until time of dilution and administration.
  • Do not freeze.

    • After Dilution

  • Once diluted, store HEMGENIX in the infusion bag protected from light.
  • Store diluted HEMGENIX in the infusion bag at 15°C to 25°C (59°F to 77°F).
  • Infuse the diluted product within 24 hours after the dose preparation
    		•
    Shelf Life Label lists the expiration date/time (24 h from the vial removal from refrigerator)
    Nominal Vial Size & Diluent Volume 1 x 1013 gc/mL, and each vial contains an extractable volume of not less than 10 mL
    Patient body weight is less than 120 kg:

  • One 500 mL 0.9% normal saline infusion bag required
  • Volume of saline solution to withdraw is equal to the total HEMGENIX dose (in mL) from one bag

    • Patient body weight is greater than or equal to 120 kg:

  • Two 500 mL 0.9% normal saline infusion bag required
  • Volume of saline solution to withdraw is equal to the total HEMGENIX dose (in mL).
  • Remove half of the dose equivalent volume from each of the two bags.
    		•
    Route of Administration Intravenous Administration


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