Brand Name
Vyjuvek
View Brand InformationFDA approval date: May 19, 2023
Form: Kit
What is Vyjuvek?
VYJUVEK is indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation in the collagen type VII alpha 1 chain gene. VYJUVEK is a herpes-simplex virus type 1 vector-based gene therapy indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation in the collagen type VII alpha 1 chain gene.
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Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Summary: The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum. Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.
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Brand Information
VYJUVEK (VYJUVEK)
1INDICATIONS AND USAGE
VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the
2DOSAGE FORMS AND STRENGTHS
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
VYJUVEK biological suspension (1 mL) is mixed into the excipient gel vial prior to administration.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose.
4.1Clinical Trials Experience
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.
Table 3Adverse Reactions (incidence >5%) Following Treatment with VYJUVEK gel (n =31)
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.
5DRUG INTERACTIONS
No drug interaction studies have been performed.
6DESCRIPTION
VYJUVEK (beremagene geperpavec-svdt) is a suspension of an HSV-1 vector-based gene therapy, mixed with the supplied sterile excipient gel for topical application on wounds. VYJUVEK is a live, replication defective HSV-1-based vector that has been genetically modified to express the human type VII collagen (COL7) protein. The parental virus for VYJUVEK was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.
VYJUVEK is an opalescent yellow to colorless biological suspension following thaw from its frozen state. Each 1 mL VYJUVEK vial contains 5×10
The excipient gel is a clear viscous solution, following thaw from its frozen state. Each 1.5 mL Excipient Gel vial contains 44 mg/mL Hydroxypropyl Methylcellulose in a solution of 0.91 mg/mL Tromethamine, 9.0 mg/mL Sodium Chloride, 0.726 mg/mL Sodium Phosphate Dibasic, 0.21 mg/mL Potassium Phosphate Monobasic.
VYJUVEK biological suspension is mixed into excipient gel prior to administration. After mixing, VYJUVEK gel consists of 5×10
Neither VYJUVEK biological suspension nor the excipient gel contains preservatives.
7CLINICAL STUDIES
The efficacy of VYJUVEK gel was evaluated in one randomized, double-blind, intra-patient placebo-controlled study (NCT04491604). The study enrolled patients with dystrophic epidermolysis bullosa (DEB) with genetically confirmed mutation(s) in the COL7A1 gene and who had two cutaneous wounds with similar size, appearance, and anatomical location. Two comparable wounds in each patient were selected and randomized to receive either topical application of VYJUVEK gel or the placebo (excipient gel) weekly for 26 weeks..
A total of 31 patients were treated with VYJUVEK and placebo. The demographic characteristics of the population were as follows: the mean age was 17 years (range 1 to 44 years) including 19 pediatric patients (aged 1 to 16 years), 20 patients (65%) were male, 20 patients (65%) were White, 6 patients (19%) were Asian, and 5 patients (16%) were American Indian or Alaskan Native. Thirty patients had autosomal recessive DEB
Primary efficacy outcome measure was improved wound healing defined as the difference in the proportion of complete (100%) wound closure at 24 Weeks confirmed at two consecutive study visits 2 weeks apart, assessed at Weeks 22 and 24 or at Weeks 24 and 26, between the VYJUVEK gel-treated and the placebo gel-treated wounds. Other efficacy outcome measures were the difference in the proportion of complete wound closure assessed at Weeks 8 and 10 or at Weeks 10 and 12 between the VYJUVEK gel-treated and the placebo gel-treated wounds. Complete (100%) wound closure was defined as durable wound closure evaluated at two consecutive visits two weeks apart. The efficacy results are summarized in Table 4.
Table 4Summary of the efficacy results for VYJUVEK gel
8PATIENT COUNSELING INFORMATION
Advise the patient or caregiverto read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise patients and caregivers of the following precautions prior to and during treatment with VYJUVEK gel:
- Avoid direct contact with treated wounds (e.g., touching and scratching) and dressings of treated wounds until the next dressing change following VYJUVEK gel application. In the event of accidental exposure, instruct patients and exposed individuals to clean the affected area [see
- Wash hands and wear protective gloves when changing wound dressings [see
- Disinfect bandages from the first dressing change with a virucidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or <0.4% ammonium chloride, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings and cleaning materials into a sealed plastic bag and dispose in household waste [see
Manufactured by:
Krystal Biotech, Inc.
2100 Wharton Street, Suite 701
Pittsburgh, PA 15203
U.S. License No. 2301
Krystal Biotech, Inc.
2100 Wharton Street, Suite 701
Pittsburgh, PA 15203
U.S. License No. 2301
VYJUVEK® is a registered trademark of Krystal Biotech, Inc.
© 2025 Krystal Biotech, Inc. All rights reserved.
9MEDICATION GUIDE VYJUVEK (vye-JOO-vek) Gel (beremagene geperpavec-svdt) biological suspension mixed with excipient gel, for topical use
MEDICATION GUIDE
VYJUVEK (Vye-JOO-vek) Gel
(beremagene geperpavec-svdt)
biological suspension mixed with gel, for topical use
10INSTRUCTIONS FOR USE VYJUVEK (vye-JOO-vek) Gel (beremagene geperpavec-svdt) biological suspension mixed with excipient gel, for topical use
This Instructions for Use contains information on how to apply VYJUVEK gel.
Read the Instructions for Use before you start using VYJUVEK gel. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
You or your caregiver should be shown how to apply VYJUVEK gel before the first use.
VyjuvekGel Syringe
Important Information You Need to Know Before Applying VYJUVEK Gel
Before Starting VYJUVEK GelIndividuals who are pregnant or nursing should not prepare or apply VYJUVEK gel and should avoid direct contact with the treated wounds or dressings from treated wounds, as this has not been formally studied. It is important to tell your healthcare provider if you are breastfeeding or plan to do so. They will then help you decide whether to stop breast-feeding, or whether to stop taking VYJUVEK gel, taking into account the benefit of breast-feeding to the baby and the benefit of VYJUVEK gel to you.
If you are allergic to beremagene geperpavec-svdt or any of its ingredients, you should not be given VYJUVEK gel.
Tell your healthcare provider about your standard of care routine including medications (prescribed and over the counter), bathing routine, dressing use, etc. before starting VYJUVEK gel.
How is VYJUVEK Gel Supplied?
Syringes containing VYJUVEK gel will be provided by the pharmacy in a sealable plastic bag. VYJUVEK gel in the syringes is ready for administration.
Syringes containing VYJUVEK gel will be provided by the pharmacy in a sealable plastic bag. VYJUVEK gel in the syringes is ready for administration.
Measures for Accidental Exposure
To avoid accidental exposure follow the below instructions for the administration and handling of VYJUVEK gel:
To avoid accidental exposure follow the below instructions for the administration and handling of VYJUVEK gel:
- Wash hands and wear protective gloves while administering VYJUVEK gel.
- In the event of an accidental exposure through a splash to the eyes or mouth, flush with clean water for at least 15 minutes.
- Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change.
- Disinfect bandages from the first dressing change with a virucidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or <0.4% ammonium chloride, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste.
Storing VYJUVEK Gel Syringes
Follow the instructions provided by the pharmacy and do not use the syringes past their expiration.
Follow the instructions provided by the pharmacy and do not use the syringes past their expiration.
- VYJUVEK gel syringes are provided by the pharmacy in a refrigerated (2° to 8°C (35.6° to 46.4°F)) container.
- VYJUVEK gel syringes can be stored at room temperature (20 to 25°C (68° to 77°F)) for up to 8 hours prior to application. 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).
- Store VYJUVEK gel syringes out of the reach of children.
- Do NOT heat the syringes or place them in the microwave.
Applying VYJUVEK Gel
Work with your healthcare provider to determine the best wound preparation, administration and dressing routine that works for you.
Work with your healthcare provider to determine the best wound preparation, administration and dressing routine that works for you.
It may not be possible to treat all wounds each week. VYJUVEK gel should be applied to wounds until they are closed before selecting new wound(s) to treat. Weekly treatment of previously treated wounds should be prioritized if they re-open.
If a dose is missed, VYJUVEK gel should be administered as soon as possible, and weekly treatments will continue. It is not recommended to stop your treatment without first consulting your doctor or nurse.
Wound Preparation
The wounds should be clean before applying VYJUVEK gel.
- Gently remove any medicines, ointments, drainage, scabbing, and dead skin at the wound area.
- Bathing is not required.
- Leaving wounds uncovered can be painful to some patients. Ensure your area is set-up and ready prior to beginning application.
- In some cases, it may be best to keep wounds covered and treat one area at a time, removing dressings as you go.
- Do not use products or dressing that may contain anti-viral agents within 24 hours prior to use of VYJUVEK gel.
- If you are unsure if a product contains an anti-viral agent, refer to the Manufacturer’s website at the end of this document for more information or contact your healthcare provider on what to avoid.
Supplies
Below is the list of supplies needed for VYJUVEK gel administration:
- VYJUVEK gel syringes
- Hydrophobic dressing
- Clean scissors
- Standard dressing
- Gloves
- Biohazard container
- Virucidal agent and absorbent material for clean-up
Follow the steps below for VYJUVEK gel administration.
The administration syringe should be primed prior to the initial application by pulling the plunger down and gently pushing it upwards, so that a small droplet of VYJUVEK gel forms at the tip of the syringe.
Step 1.Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1 cm-by-1 cm apart (width of a fingertip). The resulting droplet pattern should loosely resemble a grid. Avoid touching the administration syringe directly to the wound, only the droplet will touch the wound ( Figure 1).
Note:You can treat the wound underneath the blister cap after it has been drained. Additionally, the VYJUVEK gel can be applied directly to the hydrophobic dressing in the same 1 cm-by-1 cm pattern to the size of the wound, if direct administration is difficult.
Figure 1 Application of VYJUVEK gel to the wound
Step 2.Use the scissors to cut the hydrophobic dressing to a size slightly larger than the wound and place the dressing atop the VYJUVEK gel droplets ( Figure 2).
Figure 2 Placing the hydrophobic dressing over the treated wound
Step 3.Use the scissors to cut the standard dressing to a size slightly larger than the hydrophobic dressing and place the standard dressing atop the hydrophobic dressing ( Figure 3).
Figure 3 Placing the standard dressing over the hydrophobic dressing
Step 4.The VYJUVEK gel dressing should be left in place until the next dressing change. Disinfect VYJUVEK gel dressings, place in a sealable bag and discard into the household waste. Continue with your standard of care routine.
Disposal and Clean-up of VYJUVEK Gel
Clean all surfaces that may have come in contact with VYJUVEK gel and treat all spills (blot using absorbent material) with a virucidal agent such as 70% isopropyl alcohol, 6% hydrogen peroxide, or <0.4% ammonium chloride.
Clean all surfaces that may have come in contact with VYJUVEK gel and treat all spills (blot using absorbent material) with a virucidal agent such as 70% isopropyl alcohol, 6% hydrogen peroxide, or <0.4% ammonium chloride.
Dispose all materials (e.g., used and unused syringe (expired), cleaning materials) that may have come in contact with VYJUVEK gel into a biohazard container.
Once the VYJUVEK gel dressings are removed and disinfected with a virucidal agent, place them in a sealable bag and discard into the household waste. Standard of care routine can then be continued.
Additional Information
Manufactured by: Krystal Biotech, Inc.
For more information, go to www.vyjuvek.com or call 1-844-5-KRYSTAL (1-844-5-579-7825)
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.
Approved: September 2025