Vyjuvek should be initiated by healthcare professionals experienced in the management of patients with dystrophic epidermolysis bullosa. Posology Vyjuvek 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. 3 The recommended total maximum weekly dosing for children from birth up to 3 years old is 1 mL (2×109 PFU). The recommended total maximum weekly dosing for children above 3 years of age, adolescents, and adults is 2 mL (4×109 PFU).
Vyjuvek 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, Vyjuvek 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. 6 to < 2 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, Vyjuvek should be administered as soon as possible, and weekly dosing should be resumed thereafter.
Special populations Elderly population No dose adjustment is required in patients ≥ 65 years old. 4). During preparation, administration, and disposal, appropriate precautions must be taken. , gloves, mask, and eye protection) should be worn when handling Vyjuvek.
6). Administration For cutaneous use on wounds only. Prior to cutaneous use the suspension and gel must be thawed, and the suspension must be mixed into the gel in a pharmacy setting. 6. , clinic) or the home setting. If deemed appropriate by the healthcare professional, trained patients or caregivers may also apply Vyjuvek.
Wounds should be gently cleaned prior to cutaneous administration using a product that does not contain a virucidal agent. 5). 4 Table 2. Steps for administration Step 1. The Vyjuvek syringe should be primed prior to the initial application by pulling the plunger down and pushing it upwards, so that a small droplet of Vyjuvek forms at the tip of the syringe.
Step 2. Vyjuvek should be applied to the selected wound, in small droplets approximately 1-cm by 1-cm apart (width of a fingertip) with only the droplet touching the wound. Only the gel should contact the skin. The tip of the syringe should not touch the skin to prevent the contamination of the gel in the syringe.
Step 3. Once Vyjuvek has been administered to the wound, a hydrophobic dressing should be applied. The dressing should be cut to a size slightly larger than the wound but may vary upon patient preference. Once the Vyjuvek droplets are covered by the hydrophobic dressing, a thin even layer of Vyjuvek will form within the wound.
Step 4. The standard dressing should be cut to a size larger than the hydrophobic dressing. The standard dressing will be placed over the hydrophobic dressing to prevent dissemination of the gel to other areas of the body or close contacts.
The dressing should be left in place for approximately 24 hours after Vyjuvek application. Once the Vyjuvek dressings are removed, the patient may continue with their standard of care. Vyjuvek should continue to be administered weekly until the wounds are closed.
If previously treated wounds re-open, Vyjuvek should be applied again. If no wounds are present, Vyjuvek should not be administered.