Beremagene Geperpavec-svdt (Monograph)

Brand name: Vyjuvek
Drug class: Gene Therapy

Medically reviewed by Drugs.com on Dec 11, 2023. Written by ASHP.

Introduction

Beremagene geperpavec-svdt is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy.

Uses for Beremagene Geperpavec-svdt

Beremagene geperpavec-svdt has the following uses:

Beremagene geperpavec-svdt is a biological suspension that is used topically as a gel 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. Designated an orphan drug by FDA for this use.

Efficacy of beremagene geperpavec-svdt gel was evaluated in a randomized, double-blind, intrapatient, placebo-controlled trial in 31 patients who had clinical manifestations of DEB and genetically confirmed mutation(s) in the COL7A1 gene. For each patient, 2 comparable wounds were selected and randomized to receive either topical beremagene geperpavec-svdt gel or placebo (excipient gel) weekly for 26 weeks. Complete wound healing assessed at weeks 22 and 24, or at weeks 24 and 26, occurred in 65% of patients who received beremagene geperpavec-svdt gel compared with 26% of those who received placebo gel.

Beremagene Geperpavec-svdt Dosage and Administration

General

Beremagene geperpavec-svdt is available in the following dosage form(s) and strength(s):

Beremagene geperpavec-svdt is a biological suspension, mixed into excipient gel, for topical application. Beremagene geperpavec-svdt biological suspension is supplied as a 1 mL extractable volume in a single dose vial at a nominal concentration of 5×10⁹ plaque forming units (PFU)/mL. The excipient gel is supplied as a 1.5 mL fill volume in a separate single use vial. Beremagene geperpavec-svdt biological suspension (1 mL) is mixed into the excipient gel vial prior to administration as beremagene geperpavec-svdt gel.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For topical application only. Beremagene geperpavec-svdt gel is applied topically to wound(s) once a week.

Prepare the gel at the pharmacy by mixing beremagene geperpavec-svdt biological suspension into the excipient gel for immediate use within 8 hours of application. Only a healthcare professional should apply the gel either at a healthcare professional setting (e.g., clinic) or the home setting. Individuals who are pregnant should not prepare or apply the gel and should avoid direct contact with the treated wounds or dressings from treated wounds.

The recommended dose of beremagene geperpavec-svdt gel is based on age (see Table 1).

Maximum weekly volume is the volume after mixing beremagene geperpavec-svdt biological suspension with excipient gel.

Apply beremagene geperpavec-svdt gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1 cm-by-1 cm apart. The table below provides a reference on dose per approximate size of the wound.

For wound area over 60 cm², recommend calculating the total dose based on this table until the maximum weekly dose is reached.

It may not be possible to apply the gel to all the wounds at each treatment visit. Apply 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 full prescribing information for instructions on preparation and handling, and administration.

Related/similar drugs

Vyjuvek, Filsuvez

Cautions for Beremagene Geperpavec-svdt

Contraindications

• None.

Warnings/Precautions

Accidental Exposure

Beremagene geperpavec-svdt is a genetically modified, herpes-simplex virus type 1 vector-based, replication-deficient, non-integrating gene therapy. Beremagene geperpavec-svdt will not replicate in the subject’s cells and does not integrate into the subject cells’ native genetic material.

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.

Specific Populations

Pregnancy

There are no data with beremagene geperpavec-svdt gel use in pregnant women to inform a drug-associated risk. Animal developmental and reproductive toxicity studies have not been conducted with beremagene geperpavec-svdt.

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.

If the patient becomes pregnant while being administered beremagene geperpavec-svdt 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 beremagene geperpavec gel.

Lactation

There is no information available on the presence of beremagene geperpavec in human milk, the effects on the breastfed infant, or the effects on milk production. Animal lactation studies have not been conducted with beremagene geperpavec-svdt.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for beremagene geperpavec and any potential adverse effects on the breastfed child from beremagene geperpavec or from the underlying maternal condition.

Females and Males of Reproductive Potential

No nonclinical or clinical studies were performed to evaluate the effect of beremagene geperpavec-svdt on fertility.

Pediatric Use

The safety and effectiveness of beremagene geperpavec-svdt gel was studied in pediatric patients. The safety and efficacy findings in pediatric patients were similar to safety and efficacy findings in adult patients.

Geriatric Use

Clinical studies of beremagene geperpavec-svdt gel did not include geriatric patients 65 years of age and over.

Common Adverse Effects

The most common adverse reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose.

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

No drug interaction studies have been performed.

Actions

Mechanism of Action

Dystrophic epidermolysis bullosa (DEB) is a rare genetic skin disease 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, beremagene geperpavec can transduce both keratinocytes and fibroblasts. Following entry of beremagene geperpavec into the cells, the vector genome is deposited in the nucleus. Once in the nucleus, transcription of the encoded human COL7A1is 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 have lower than normal functional anchoring fibrils, and patients with autosomal recessive DEB have no functional anchoring fibrils.

Advice to Patients

• Advise patients or caregivers to avoid direct contact with treated wounds (e.g., touching and scratching) and dressings of treated wounds for approximately 24 hours following beremagene geperpavec gel application. In the event of accidental exposure, instruct patients and exposed individuals to clean the affected area.

• Advise patients or caregivers to wash hands and wear protective gloves when changing wound dressings.

• Advise patients or caregivers to 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.

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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