VYJUVEK Kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other cicatrizants class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Beremagene geperpavec-svdt is used to treat certain adults and children 6 months of age or older who have dystrophic epidermolysis bullosa (an inherited disorder that causes the skin to be fragile leading to blisters, wounds, skin infections, and scarring). Beremagene geperpavec-svdt is in a class of medications called gene therapy. It works by replacing a gene that promotes wound healing by strengthening and stabilizing the skin.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $23,033.88 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3401 | $1,032.437 / J3401 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vyjuvekthis 82194-0510-02 | Krystal | 1 kit | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | May 19, 2035 |
Is there a biosimilar for VYJUVEK GEL?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82194-0510-02 You're viewing this | 1 KIT in 1 CARTON (82194-510-02) * 1.5 mL in 1 VIAL (82194-001-01) * 1 mL in 1 VIAL (82194-501-01) | 2023-05-19 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS 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 collagen type VII alpha 1 chain (COL7A1) gene. VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For topical application only. Age Range Maximum Weekly Dose (PFU) Maximum Weekly Volume (mL)* <3 years old 2×10 9 1 ≥3 years old 4×10 9 2 PFU=plaque forming units; mL=milliliter *Maximum weekly volume after mixing VYJUVEK biological suspension with excipient gel Apply VYJUVEK gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart. (2.3) Apply VYJUVEK gel on wounds once a week.
(2.1) See full prescribing information for instructions on preparation and handling, (2.2) and administration (2.3) .
2.1Dose For topical application on wounds only. The recommended dose of VYJUVEK gel is based on age (Table 1). VYJUVEK gel is applied topically to wound(s) once a week.
Table 1 Maximum Weekly Dose of VYJUVEK by Age Age Range Maximum Weekly Dose (PFU) Maximum Weekly Volume (mL)* <3 years old 2×10 9 1 ≥3 years old 4×10 9 2 PFU=plaque forming unit; mL=milliliter *Maximum weekly volume is the volume after mixing VYJUVEK biological suspension with excipient gel. It may not be possible to apply VYJUVEK gel to all the wounds at each treatment visit. Apply VYJUVEK gel to wounds until they are closed before selecting new wound(s) to treat.
Prioritize weekly treatment to previously treated wounds if they re-open. [ see Administration (2.3) ] If a dose is missed, apply VYJUVEK gel as soon as possible and resume weekly dosing thereafter.
2.2Preparation Important Preparation Instructions Prepare VYJUVEK gel at the pharmacy by mixing the VYJUVEK biological suspension into the excipient gel for immediate use. [see Storage and Handling ( 16.2 )] The VYJUVEK gel prepared at the pharmacy, should be applied by a healthcare professional (HCP), patient, or caregiver either at a healthcare professional setting (e.g., clinic) or at a home setting. Individuals who are pregnant should not prepare or apply VYJUVEK gel and should avoid direct contact with the treated wounds or dressings from treated wounds [see Accidental Exposure to VYJUVEK ( 5.1 )].
Below is the list of supplies needed for VYJUVEK gel preparation: One (1) carton containing one (1) VYJUVEK biological suspension vial and one (1) excipient gel vial (Figure 1) Two (2) 18-gauge needles Two (2) to four (4) 1 mL administration syringes One (1) 3 mL preparation syringe Two (2) to four (4) syringe caps Protective gloves 70% isopropyl alcohol pads Biohazard container Labels for administration syringes Virucidal agent for clean-up Follow the steps below for VYJUVEK gel preparation. PREPARE THE PREPARATION SYRINGE 1.
Wash hands and put on protective gloves. 2. Remove both vials from the carton and thaw the VYJUVEK biological suspension vial and the excipient gel vial at room temperature for AT LEAST 20 minutes (Figure 1).
Figure 1 Carton containing the VYJUVEK biological suspension vial and excipient gel vial Note: Visually inspect the vials to ensure both are in liquid form and completely thawed. Excipient gel is more viscous and will take longer to thaw (Figure 2). Figure 2 Timelapse of excipient gel thaw from 0 minutes to 20 minutes Note: Once either the VYJUVEK biological suspension or the excipient gel is thawed, do not refreeze.
3. Invert the VYJUVEK biological suspension vial 4-5 times. Do not invert the excipient gel vial.
4. Remove the caps from the vials and clean each vial stopper with a 70% isopropyl alcohol pad. Allow them to dry.
5. Aseptically connect an 18-gauge needle to the 3 mL preparation syringe. 6.
Remove the needle cap and puncture the VYJUVEK biological suspension vial stopper. 7. Hold the vial at 45 to 90 degrees and withdraw 1 mL of VYJUVEK biological suspension into the preparation syringe (Figure 3).
8. Remove the preparation syringe (still connected to the needle) containing 1 mL of VYJUVEK biological suspension from the vial. Do NOT engage the safety lock.
Figure 3 The removal of 1 mL of biological suspension using the preparation syringe 9. Discard the VYJUVEK biological suspension vial in the biohaz…
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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 9 PFU/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. VYJUVEK is a biological suspension, mixed into excipient gel, for topical application. VYJUVEK biological suspension is supplied as a 1 mL extractable volume in a single dose vial at a nominal concentration of 5×10 9 PFU/mL.
The excipient gel is supplied as a 1.5 mL fill volume in a separate single use vial. VYJUVEK biological suspension (1 mL) is mixed into the excipient gel vial prior to administration as VYJUVEK gel. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Accidental Exposure to VYJUVEK: Avoid direct contact with treated wounds and dressings of treated wounds until the next dressing change, following application. Clean the affected area if accidental exposure occurs. (5.1)
5.1Accidental Exposure to VYJUVEK 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.
5.1Accidental Exposure to VYJUVEK 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (>5%) were itching, chills, redness, rash, cough, and runny nose. The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. (6) To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
6.1Clinical 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 3 Adverse Reactions (incidence >5%) Following Treatment with VYJUVEK gel (n =31) 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.
6.1Clinical 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 3 Adverse Reactions (incidence >5%) Following Treatment with VYJUVEK gel (n =31) 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.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been performed.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.3Females and Males of Reproductive Potential No nonclinical or clinical studies were performed to evaluate the effect of VYJUVEK on fertility.
8.4Pediatric Use The safety and effectiveness of VYJUVEK have been established in pediatric patients with dystrophic epidermolysis bullosa (DEB). The use in pediatric patients (0 to 16 years of age) was supported by evidence from adequate and well-controlled study which included 19 pediatric patients 1 year of age and older. [ see Adverse Reactions ( 6 ) Clinical Studies (14) ].
8.5Geriatric Use Clinical study of VYJUVEK gel did not include geriatric patients aged 65 years and older.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of VYJUVEK have been established in pediatric patients with dystrophic epidermolysis bullosa (DEB). The use in pediatric patients (0 to 16 years of age) was supported by evidence from adequate and well-controlled study which included 19 pediatric patients 1 year of age and older. [ see Adverse Reactions ( 6 ) Clinical Studies (14) ].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical study of VYJUVEK gel did not include geriatric patients aged 65 years and older.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dystrophic epidermolysis bullosa (DEB) is caused by mutation(s) in the COL7A1 gene, which results in reduced or absent levels of biologically active COL7. Upon topical application to the wounds, VYJUVEK can transduce both keratinocytes and fibroblasts. Following entry of VYJUVEK into the cells, the vector genome is deposited in the nucleus.
Once in the nucleus, transcription of the encoded human COL7A1 is initiated. The resulting transcripts allow for production and secretion of COL7 by the cell in its mature form. These COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils.
The anchoring fibrils hold the epidermis and dermis together and are essential for maintaining the integrity of the skin. Patients with autosomal dominant DEB (DDEB) have lower than normal functional anchoring fibrils, and patients with RDEB have no functional anchoring fibrils.
12.2Pharmacodynamics The pharmacodynamic activity (expression and localization of COL7 transgene) of VYJUVEK gel was demonstrated in an initial clinical study (n=6 patients). Linear deposition of the non-collagenous domain 1 (NC1) and domain 2 (NC2) of COL7 were observed at the dermal-epidermal junction in skin biopsies harvested after VYJUVEK treatment.
12.3Pharmacokinetics In an initial clinical study, viral vector DNA was detected in skin swab samples in all nine treated patients, with maximum level ranging from 5.1×10 4 to 4.1×10 8 vector genomes. In 6 out of 9 patients (67%), negative shedding was confirmed with three measurements below limit of detection within 8 weeks of treatment with VYJUVEK. No viral vector DNA was detected in blood or urine.
In the 31-patient randomized, double-blind, intra-patient placebo-controlled trial, systemic and potential environmental exposure assessments were conducted at weekly clinical site visits via quantification of VYJUVEK genomes in blood, urine, skin swabs, and bandage samples (vector shedding) using a validated qPCR assay, and detection of infectious viral particles in skin swabs (infectivity) using a validated plaque titer assay. All blood samples and all but one urine sample collected throughout the study were below the limit of detection.
Skin swabs from 19 of the 31 patients (61%) were positive for viral vector following treatment with VYJUVEK. Negative shedding from skin swabs was achieved in 16 of the 19 patients (84%) within six weeks following treatment with VYJUVEK. Most wound dressings (94%, 29/31) contained a range of detectable vector genomes.
However, no extracellular infectious particles were detected on the skin surface of any patient at any timepoint tested, after topical VYJUVEK application.
12.6Immunogenicity There was minimum potential for systemic exposure to VYJUVEK. Antibodies against the viral vector (HSV-1) and transgene protein (COL7) were evaluated in a subset of patients in the randomized, intra-patient placebo-‑controlled clinical study. A total of 64% of evaluated patients (14/22) were anti-HSV-1 antibody positive at baseline.
Six of the 8 anti-HSV-1 seronegative patients seroconverted by Week 26 following treatment with VYJUVEK. For patients with available matched baseline and end-of-study serum samples, anti‑drug antibodies (ADAs) to COL7 were detected in 72% (13/18) of patients treated with VYJUVEK for up to 26 weeks. Data are limited to perform correlative assessment on the impact of ADA on pharmacodynamic activity.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dystrophic epidermolysis bullosa (DEB) is caused by mutation(s) in the COL7A1 gene, which results in reduced or absent levels of biologically active COL7. Upon topical application to the wounds, VYJUVEK can transduce both keratinocytes and fibroblasts. Following entry of VYJUVEK into the cells, the vector genome is deposited in the nucleus.
Once in the nucleus, transcription of the encoded human COL7A1 is initiated. The resulting transcripts allow for production and secretion of COL7 by the cell in its mature form. These COL7 molecules arrange themselves into long, thin bundles that form anchoring fibrils.
The anchoring fibrils hold the epidermis and dermis together and are essential for maintaining the integrity of the skin. Patients with autosomal dominant DEB (DDEB) have lower than normal functional anchoring fibrils, and patients with RDEB have no functional anchoring fibrils.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/ STORAGE AND HANDLING
16.1How Supplied Each carton of VYJUVEK (NDC 82194-510-02) contains one single-dose vial of VYJUVEK biological suspension and one single-dose vial of excipient gel. VYJUVEK biological suspension (inner NDC 82194-501-01), green cap, is supplied as a 1 mL extractable volume in a single-use, single-dose vial containing 5×10 9 PFU/mL. Excipient gel (inner NDC 82194-001-01), blue cap, is supplied as a 1.5 mL fill volume in a separate single-use, single-dose vial.
16.2Storage and Handling 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 Dosage and Administration (2) for appropriate handling, preparation, application, and disposal of materials. Follow universal biohazard precautions for handling.
16.1How Supplied Each carton of VYJUVEK (NDC 82194-510-02) contains one single-dose vial of VYJUVEK biological suspension and one single-dose vial of excipient gel. VYJUVEK biological suspension (inner NDC 82194-501-01), green cap, is supplied as a 1 mL extractable volume in a single-use, single-dose vial containing 5×10 9 PFU/mL. Excipient gel (inner NDC 82194-001-01), blue cap, is supplied as a 1.5 mL fill volume in a separate single-use, single-dose vial.
📦 Storage and Handling ▾
16.2Storage and Handling 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 Dosage and Administration (2) for appropriate handling, preparation, application, and disposal of materials. Follow universal biohazard precautions for handling.
📋 Description ▾
11 DESCRIPTION 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 9 PFU/mL of VYJUVEK in a solution of 100.0 mL/L Glycerol, 8.0 mg/mL Sodium Chloride, 2.16 mg/mL Sodium Phosphate Dibasic, 0.2 mg/mL Potassium Chloride, 0.2 mg/mL Potassium Phosphate Monobasic. 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 9 PFU in a volume of 2.5 mL.
Neither VYJUVEK biological suspension nor the excipient gel contains preservatives.
💬 Information for Patients ▾
17 PATIENT 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 Warnings and Precautions (5.1) ].
Wash hands and wear protective gloves when changing wound dressings [see Preparation (2.2) ]. 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 Administration (2.3) ].
Manufactured by: 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.
💬 Medication Guide ▾
MEDICATION 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 What is the most important information I should know about VYJUVEK Gel? …The VYJUVEK® biological suspension must be mixed with the gel at the pharmacy prior to use. …VYJUVEK gel should be applied by a healthcare professional (HCP) or by a patient/caregiver either at a healthcare professional setting (e.g., clinical) or a home setting.
What is VYJUVEK Gel? …VYJUVEK gel is a prescription medicine for the treatment of wounds (topical use only), in adult and pediatric patients who have dominant or recessive dystrophic epidermolysis bullosa. Who should not take VYJUVEK Gel? … Individuals who are pregnant should not prepare or apply VYJUVEK gel and should avoid direct contact with the treated wounds or dressings from treated wounds. Before taking VYJUVEK Gel, tell your healthcare provider about all of your medical conditions, including if you: … are pregnant or plan to become pregnant.
It is not known if VYJUVEK gel will harm your unborn baby. …are breast feeding or plan to breast feed. It is not known if VYJUVEK gel passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take VYJUVEK Gel? …See the Instructions For Use for detailed instructions. …Use VYJUVEK exactly as your healthcare providers tells you to and do not use past the expiration date. If you have questions, reach out to your provider or the pharmacy for further instructions. What should I avoid while taking VYJUVEK Gel? …Avoid direct contact with treated wounds (e.g., touching or scratching) and dressings of treated wounds until the next dressing change following VYJUVEK gel application. …Individuals should wear protective gloves when assisting with changing wound dressings and handling the disposal of the dressings.
What are the possible side effects of VYJUVEK Gel? …The most common side effects of VYJUVEK gel are itching, chills, redness, rash, cough, and runny nose. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VYJUVEK Gel? …See the Instructions For Use for detailed instructions. …VYJUVEK gel syringes may remain 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). …Follow expiration information provided by the pharmacy. If you have any questions, reach out to the pharmacy for additional information.
General information about the safe and effective use of VYJUVEK Gel …Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VYJUVEK gel for a condition for which it was not prescribed. Do not give VYJUVEK gel to other people, even if they have the same symptoms that you have.
It may harm them. …You can ask your pharmacist or healthcare provider for information about VYJUVEK gel that is written for health professionals. What are the ingredients in VYJUVEK Gel? Active ingredients: beremagene geperpavec-svdt Inactive ingredients: glycerol, sodium chloride, sodium phosphate dibasic, potassium chloride, potassium phosphate monobasic, hydroxypropyl methylcellulose, and tromethamine Manufactured by: Krystal Biotech, Inc.
2100 Wharton Street, Suite 701 Pittsburgh, PA 15203 U.S. License No. 2301 For more information, go to www.vyjuvek.com or call 1-844-5-KRYSTAL (1-844-5-579-7825) This Medication Guide has been approved by the U.S.
Food and Drug Administration. Revised: 09/2025