Active Ingredient: Beremagene geperpavec
Beremagene geperpavec is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is < 3
Cutaneous, 2,000,000,000 plaque-forming units beremagene geperpavec, divided weekly.
Regimen B, in case that patient age in years is ≥ 3
Cutaneous, 4,000,000,000 plaque-forming units beremagene geperpavec, divided weekly.
Beremagene geperpavec is applied cutaneously to wound(s) once a week in small droplets in a grid-like pattern, approximately 1-cm by 1-cm apart. All wounds may not be possible to be treated at each treatment visit.
The recommended total maximum weekly dosing for children from birth up to 3 years old is 2×109 PFU. The recommended total maximum weekly dosing for children above 3 years of age, adolescents, and adults is 4×109 PFU.
Beremagene geperpavec should be applied to wounds until they are closed before selecting new wound(s) to treat. Weekly treatment of previously treated wounds should be prioritised if they re-open. If no wounds are present, beremagene geperpavec should not be administered.
The table below provides a reference on dose per approximate size of the wound in children, adolescents, and adults.
Table 1. Dose by wound area:
| Wound area (cm2)* | Dose (PFU)a |
|---|---|
| <20 | <4×108 |
| 20 to <40 | 4×108 to <8×108 |
| 40 to 60 | 8×108 to <1.2×109 |
| 60 to <200 | 1.2×109 to <4×109 |
PFU = plaque forming units.
a The maximum dose in children below 3 years of age is 1 mL (2×109 PFU)
If a dose is missed, beremagene geperpavec should be administered as soon as possible, and weekly dosing should be resumed thereafter.
Wounds should be gently cleaned prior to cutaneous administration using a product that does not contain a virucidal agent. Medicinal products and ointments at the wound area should be removed and the wound should be cleansed prior to beremagene geperpavec administration to ensure no reduction in its activity.
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