DOSING & ADMINISTRATION

The image is used for illustrative purposes only and does not represent actual patients.

HEMGENIX® DOSING & ADMINISTRATION

PRESCRIBE ONE-TIME DOSE1

HEMGENIX® is administered as a one-time intravenous infusion after dilution of the required dose with sodium chloride 9 mg/mL (0.9%) solution for infusion — with infusion times lasting around 1–2 hours in an outpatient setting. No special pretreatment of patients or product thawing are required.

  • Each dosing kit is personalised according to patient weight
  • Delivered as a single dose of 2 x 1013 gc/kg (2 mL/kg) body weight
  • Onset of effect may occur within weeks post-dose, and haemostatic support may be needed during the first weeks (refer to section 6.6 of the SmPC for instructions on dilution of the product)

DOSING1

  • HEMGENIX® has a nominal concentration of 1 x 1013 gc/mL, and each vial contains an extractable volume of 10 mL. The recommended dose of HEMGENIX® is 2 x 1013 gc/kg body weight administered as a single intravenous infusion in an outpatient setting
  • HEMGENIX® is a solution for intravenous infusion after dilution; no product thawing is required. It is provided in kits containing 10 to 48 vials; each kit is ordered based on the patient’s body weight
  • HEMGENIX® must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration
  • HEMGENIX® does not contain preservatives. Use aseptic techniques during the preparation and administration of HEMGENIX®

ADMINISTRATION1

Steps required for the administration of HEMGENIX® as a single-dose intravenous infusion through a peripheral venous catheter:

Icon IV 24 hours
Icon IV inline filter
Icon IV drip chamber
Icon IV infusion rate
Icon IV flush

IV, intravenous; PES, polyether sulfone; SmPC, Summary of Product Characteristics.

Reference

1. HEMGENIX® (etranacogene dezaparvovec). Summary of product characteristics.