Vyjuvek Drug Information
Generic name: VYJUVEK
Uses of 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.
Dosage & Administration of Vyjuvek
| Age Range | Maximum Weekly Dose (PFU) |
|---|---|
| <3 years old | 2×10 9 |
| ≥3 years old | 4×10 9 |
| PFU=plaque forming units; mL=milliliter*Maximum weekly volume after mixing VYJUVEK biological suspension with excipient gel | |
Side Effects of Vyjuvek
Clinical 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 Chills 3 Redness 2 Rash 2 Cough 2 Runny Nose 2 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.
Warnings & Cautions for Vyjuvek
Accidental 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.
Drug Interactions with Vyjuvek
No drug interaction studies have been performed.
Pregnancy Safety for Vyjuvek
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.
Pediatric Use of Vyjuvek
Pediatric 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..
Clinical Studies of Vyjuvek
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 and one patient had autosomal dominant DEB. The size of the VYJUVEK gel-treated wounds ranged from 2 to 57 cm 2, with 74% of wounds < 20 cm 2 and 19% from 20 to < 40 cm 2. The size of the placebo gel-treated wounds ranged from 2 to 52 cm 2, with 71% of wounds < 20 cm 2 and 26% from 20 to < 40 cm 2. 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 4 Summary of the efficacy results for VYJUVEK gel Wound Closure Assessment Timepoints Complete Wound Closure, n (%) VYJUVEK gel (N=31) Complete Wound Closure, n (%) Placebo gel (N=31) Treatment Difference (95% CI) p value Weeks 22 & 24 or Weeks 24 & 26 20 8 39% 0.012 Weeks 8 & 10 or Weeks 10 & 12 21 7 45% 0.003
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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