Vyjuvek
(beremagene geperpavec-svdt)Dosage & Administration
For topical application only.
Age Range | Maximum Weekly Dose (plaque forming units; PFU) | Maximum Weekly Volume (milliliter; mL) * |
6 months to <3 years old | 1.6×10 9 | 0.8 |
≥ 3 years old | 3.2×10 9 | 1.6 |
Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart. (2.3)
The table below provides a reference on dose per approximate size of the wound.
Wound Area (cm 2) * | Dose (PFU) | Volume (mL) |
<20 | 4×10 8 | 0.2 |
20 to <40 | 8×10 8 | 0.4 |
40 to 60 | 1.2×10 9 | 0.6 |
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Vyjuvek Prescribing Information
VYJUVEK is indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1)gene.
Administration
Below is the list of supplies needed for VYJUVEK gel administration:
- The administration syringes
- Non-adherent hydrophobic dressing
- Scissors
- Standard dressing
- Protective gloves
- Biohazard container
- Virucidal agent for clean-up
Use the VYJUVEK gel in the administration syringes immediately after preparation. If immediate use is not possible, please refer to section [ seeStorage and Handling (16.2)].
VYJUVEK GEL ADMINISTRATION
Follow the steps below for VYJUVEK gel administration.
- Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart. The resulting droplet pattern should loosely resemble a grid. Avoid touching the administration syringe to the skin ( Figure 14).
Table 2below provides a reference on dose per approximate size of the wound.
Table 2 by Wound Size
* For wound area over 60 cm 2, recommend calculating the total dose based on Table 2 until the maximum weekly dose in Table 1is reached. Wound Area (cm 2) Dose (PFU) Volume (mL) < 20
4×10 8
0.2
20 to < 40
8×10 8
0.4
40 to 60
1.2×10 9
0.6
- Use the clean scissors to cut the non-adherent hydrophobic dressing to a size slightly larger than the wound and place the dressing atop the VYJUVEK gel droplets ( Figure 15).
- 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).
- 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.
- Dispose all materials (e.g., syringe, cleaning materials) that may have come in contact with VYJUVEK biological suspension or gel into a biohazard bag or container.
- Discard unused administration syringes containing the VYJUVEK gel after preparation into a biohazard bag or container [ see Storage and Handling (16.2)] .
- Do not change wound dressing within approximately 24 hours after VYJUVEK gel application.
VYJUVEK is an opalescent yellow to colorless biological suspension, mixed into excipient gel, for topical application. VYJUVEK biological suspension is supplied as a 1.0 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 (1.0 mL) is mixed into the excipient gel vial prior to administration.
Pregnancy
Risk Summary
There are no data with VYJUVEK gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with VYJUVEK.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
If the patient becomes pregnant while being administered VYJUVEK gel, the patient should be apprised of the potential hazards to the fetus and neonate. Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with VYJUVEK gel.
Lactation
Risk Summary
There is no information available on the presence of VYJUVEK in human milk, the effects on the breastfed infant, or the effects on milk production. Animal lactation studies have not been conducted with VYJUVEK.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYJUVEK and any potential adverse effects on the breastfed child from VYJUVEK or from the underlying maternal condition.
Females and Males of Reproductive Potential
No nonclinical or clinical studies were performed to evaluate the effect of VYJUVEK on fertility.
Pediatric Use
The safety and effectiveness of VYJUVEK gel was studied in pediatric patients. The safety and efficacy findings of VYJUVEK gel in pediatric patients were similar to safety and efficacy findings in adult patients. [ see Clinical Studies (14)].
Geriatric Use
Clinical studies of VYJUVEK gel did not include geriatric patients aged 65 years and over.
None.
Accidental Exposure to VYJUVEK
VYJUVEK is a genetically modified, herpes-simplex virus type 1 vector-based, replication-deficient, non-integrating gene therapy. VYJUVEK will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material. For precautions,
- Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds for approximately 24 hours following treatment.
- Wear protective gloves when assisting subjects with changing wound dressings and handling the disposal.
- In the event of an accidental exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes.