Vyjuvek
(Vyjuvek)Dosage & Administration
Below is the list of supplies needed for VYJUVEK gel administration:
VYJUVEK GEL ADMINISTRATION
Note: The administration 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 gel forms at the tip of the syringe.
Follow the steps below for VYJUVEK gel administration.
1. Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart (width of a fingertip). The resulting droplet pattern should loosely resemble a grid. Avoid touching the administration syringe to the skin and/or wound (Figure 14).
Figure 14 Application of VYJUVEK gel to the wound
Table 2below provides a reference on dose per approximate size of the wound.
| PFU= plaque forming unit; mL= milliliter; cm= centimeter * For wound area over 60 cm 2, recommend calculating the total dose based on Table 2 until the maximum weekly dose in Table 1 is reached. | ||
| Wound Area (cm 2) | Dose (PFU) | Volume (mL) |
|---|---|---|
< 20 | 4×10 | 0.2 |
20 to < 40 | 8×10 | 0.4 |
40 to 60 | 1.2×10 | 0.6 |
2. Use the clean scissors to cut the hydrophobic dressing to a size slightly larger than the wound and place the dressing atop the VYJUVEK gel droplets (Figure 15).
Figure 15 Placing the hydrophobic dressing over the treated wound
3. Use the scissors to cut the standard dressing used by the patient to a size slightly larger than the hydrophobic dressing and place the standard dressing atop the hydrophobic dressing (Figure 16).
Figure 16 Placing the standard dressing over the hydrophobic dressing
4. Clean all surfaces that may have come in contact with VYJUVEK gel and treat all spills with a virucidal agent such as 70% isopropyl alcohol, 6% hydrogen peroxide or <0.4% ammonium chloride. Blot using absorbent materials.
5. Dispose all materials (e.g., syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.
6. Discard unused administration syringes containing the VYJUVEK gel after preparation into a biohazard container [
Store the VYJUVEK carton in the pharmacy at -15°C to -25°C (5°F to -13°F). If a freezer is not available, the carton can be refrigerated in the pharmacy (2° to 8°C (35.6° to 46.4°F)) for up to 1 month.
Prior to use, VYJUVEK requires mixing into excipient gel in the pharmacy.
Administration syringes containing the VYJUVEK gel may remain at room temperature (20 to 25°C (68° to 77°F)) for up to 8 hours prior to application. If immediate use is not possible, administration syringes can be kept in an appropriate insulated or temperature regulated secondary container for up to 48 hours at 2° to 8°C (35.6° to 46.4°F).
Discard material if it falls out of the parameters described above.
VYJUVEK is a replication deficient HSV-1-based gene therapy. See
7. The dressing should be left in place until the next dressing change after VYJUVEK gel application. Once the VYJUVEK dressings are removed, the patient may continue with their standard of care.
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Vyjuvek Prescribing Information
VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the
Below is the list of supplies needed for VYJUVEK gel administration:
- The administration syringes
- Hydrophobic dressing
- Scissors
- Standard dressing
- Protective gloves
- Biohazard container
- Virucidal agent for clean-up
VYJUVEK GEL ADMINISTRATION
Note: The administration 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 gel forms at the tip of the syringe.
Follow the steps below for VYJUVEK gel administration.
1. Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart (width of a fingertip). The resulting droplet pattern should loosely resemble a grid. Avoid touching the administration syringe to the skin and/or wound (Figure 14).
Figure 14 Application of VYJUVEK gel to the wound
Table 2below provides a reference on dose per approximate size of the wound.
| PFU= plaque forming unit; mL= milliliter; cm= centimeter * For wound area over 60 cm 2, recommend calculating the total dose based on Table 2 until the maximum weekly dose in Table 1 is reached. | ||
| Wound Area (cm 2) | Dose (PFU) | Volume (mL) |
|---|---|---|
< 20 | 4×10 | 0.2 |
20 to < 40 | 8×10 | 0.4 |
40 to 60 | 1.2×10 | 0.6 |
2. Use the clean scissors to cut the hydrophobic dressing to a size slightly larger than the wound and place the dressing atop the VYJUVEK gel droplets (Figure 15).
Figure 15 Placing the hydrophobic dressing over the treated wound
3. Use the scissors to cut the standard dressing used by the patient to a size slightly larger than the hydrophobic dressing and place the standard dressing atop the hydrophobic dressing (Figure 16).
Figure 16 Placing the standard dressing over the hydrophobic dressing
4. Clean all surfaces that may have come in contact with VYJUVEK gel and treat all spills with a virucidal agent such as 70% isopropyl alcohol, 6% hydrogen peroxide or <0.4% ammonium chloride. Blot using absorbent materials.
5. Dispose all materials (e.g., syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard container.
6. Discard unused administration syringes containing the VYJUVEK gel after preparation into a biohazard container [
Store the VYJUVEK carton in the pharmacy at -15°C to -25°C (5°F to -13°F). If a freezer is not available, the carton can be refrigerated in the pharmacy (2° to 8°C (35.6° to 46.4°F)) for up to 1 month.
Prior to use, VYJUVEK requires mixing into excipient gel in the pharmacy.
Administration syringes containing the VYJUVEK gel may remain at room temperature (20 to 25°C (68° to 77°F)) for up to 8 hours prior to application. If immediate use is not possible, administration syringes can be kept in an appropriate insulated or temperature regulated secondary container for up to 48 hours at 2° to 8°C (35.6° to 46.4°F).
Discard material if it falls out of the parameters described above.
VYJUVEK is a replication deficient HSV-1-based gene therapy. See
7. The dressing should be left in place until the next dressing change after VYJUVEK gel application. Once the VYJUVEK dressings are removed, the patient may continue with their standard of care.
VYJUVEK is an opalescent yellow to colorless biological suspension, mixed into excipient gel, for topical application. VYJUVEK biological suspension is supplied as a 1 mL extractable volume in a single-use vial with a green cap, at a nominal concentration of 5×10
9PFU/mL. The excipient gel is a clear viscous solution supplied as a 1.5 mL fill volume in a separate single-use vial with a blue cap.
VYJUVEK biological suspension (1 mL) is mixed into the excipient gel vial prior to administration.
None.
Accidental exposure to VYJUVEK may occur to close contacts and caregivers. VYJUVEK is a genetically modified, herpes-simplex virus type 1 vector-based, replication-deficient, non-integrating gene therapy. VYJUVEK will not replicate in the patient’s cells and does not integrate into the patient cells’ native genetic material. For precautions,
- Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change.
- Wear protective gloves when assisting patients with changing wound dressings and handling the disposal.
- In the event of an accidental exposure through a splash to the eyes or mucous membranes, flush with clean water for at least 15 minutes.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflects exposure to VYJUVEK gel in a randomized, intra-patient placebo‑controlled study. A total of 31 patients with dystrophic epidermolysis bullosa (DEB), including 30 patients with autosomal recessive DEB and one patient with autosomal dominant DEB received topical administration of VYJUVEK gel to their wounds. The age of the patients ranged from 1 year to 44 years (mean age 17 years). Of the 31 patients, 19 (61%) were pediatric patients (less than 17 years of age), and 11 (36%) were females. Each patient received weekly topical application of VYJUVEK gel at one or more wound sites and placebo at a matching wound site as an intra-subject comparator. The median duration of exposure to VYJUVEK gel was 25 weeks. The most frequent adverse reactions (incidence >5%) observed in the study are summarized in Table 3. There were no discontinuations due to adverse reactions.
Adverse Reactions | Patients n (%) |
Itching | 3 (10) |
Chills | 3 (10) |
Redness | 2 (6) |
Rash | 2 (6) |
Cough | 2 (6) |
Runny Nose | 2 (6) |
Adverse Reactions | Patients n (%) |
Itching | 3 (10) |
Chills | 3 (10) |
Redness | 2 (6) |
Rash | 2 (6) |
Cough | 2 (6) |
Runny Nose | 2 (6) |
In addition, the safety profile of VYJUVEK in two patients with autosomal recessive DEB (RDEB) of six and seven months of age, respectively, who received topical VYJUVEK gel weekly in an open-label study was similar to the safety profile of VYJUVEK observed in the randomized, intra-patient placebo‑controlled study described above.