Vyjuvek

Generic name: beremagene-geperpavec-svdt
Dosage form: Topical gel
Drug class: Miscellaneous topical agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 16, 2024.

What is Vyjuvek?

Vyjuvek (beremagene-geperpavec-svdt) is a topical gel that promotes wound healing in adults and children aged 6 months of age and older with a rare, serious, genetic skin disorder called dystrophic epidermolysis bullosa (DEB).

• Suitable for patients with DEB with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
• Vyjuvek was the first treatment for DEB to be approved and is still the only treatment for DEB to have been approved.

Vyjuvek works by treating the root cause of DEB. DEB is caused by one or more mutations in the COL7A1 gene, resulting in missing or faulty COL7 protein. This protein helps connect the dermis (inner layer of the skin) to the epidermis (outer layer). Without it, the skin becomes extremely fragile, with minor friction or trauma (such as putting on a shirt) causing blisters and tears. Vyjuvek's mechanism of action is to correct the underlying skin defect of DEB by delivering new COL7A1 genes directly to DEB skin wounds and allowing the binding of the dermis to the epidermis, promoting wound healing.

Vyjuvek gained FDA approval on May 19, 2023.

Vyjuvek side effects

The most common side effects of Vyjuvek include:

• itching
• chills
• redness
• rash
• cough
• a runny nose.

Serious side effects and warnings

In clinical trials, there were no drug-related serious adverse events or discontinuations due to treatment-related events.

Handle Vyjuvek with care to avoid accidental exposure. Avoid touching treated wounds and dressings for at least 24 hours after application. Properly dispose of used dressings and wash any accidental skin contact thoroughly.

To report suspected adverse reactions, contact Krystal Biotech, Inc. at 1-844-557-9782 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Related/similar drugs

Before receiving

Before your healthcare provider applies Vyjuvek, tell them about all your medical conditions, including any of skin disorders you may have;

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.

How is Vyjuvek administered?

Vyjuvek is a topical gel that is applied by a healthcare provider to the wounds of patients with DEB once a week, either in the home or a healthcare setting.

• Your healthcare provider will mix the Vyjuvek gel with the Vyjuvek biological suspension.
• Once the gel is mixed with the biological suspension, the gel is dotted evenly over the wound in a grid-like pattern (1cm by 1cm apart) and then covered with a dressing.

Once Vyjuvek has been applied, patients or their caregivers should:

• Not directly touch the treated wound or the dressing covering it for approximately 24 hours
• Wear protective gloves when changing wound dressings and disposing of the dressings. Disinfect bandages from the first dressing change with an anti-viral agent and seal them in a plastic bag before putting them in the household waste. Put any subsequently used dressings in a sealed plastic bag in the household waste
• Flush any mucous membranes with clean water for at least 15 minutes in the event of accidental exposure.

For more information about using Vyjuvek, patients, caregivers, and healthcare professionals can call Krystal Connect at 1-844-5-KRYSTAL.

Vyjuvek dosing (age-based)

Vyjuvek is applied to the skin only. The weekly dose that can be applied depends on the age of the patient.

• 6 months to <3 years: 1.6 x 10⁹ PFU or 0.8mL of reconstituted gel
• 3 years and older: 3.2 x 10⁹ PFU or 1.6mL of reconstituted gel.

Vyjuvek dosing (wound size)

The amount needed per wound depends on the size of the wound.

Vyjuvek can be re-dosed weekly as needed.

What happens if I miss a dose?

It is important to continue weekly treatment with Vyjuvek until each treated wound is fully healed. Once completely healed, other wounds can be treated with Vyjuvek.

If you miss a dose of Vyjuvek, it should be applied as soon as possible. After that, resume weekly dosing.

What other drugs will affect Vyjuvek?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor about all the other medications you apply to your skin or take by mouth.

No formal drug interaction studies have been performed with Vyjuvek.

See the Vyjuvek Package Insert for a full list of interactions.

Vyjuvek ingredients

Active ingredients: beremagene-geperpavec-svdt. This is a non-invasive, genetically modified, herpes simplex virus type 1 (HSV-1) vector-based, replication-deficient, nonintegrating gene therapy.

• HSV-1 represents a safe and straightforward way of delivering 2 copies of the COL7A1 gene without any adverse effects on human cells because modified HSV-1 will not replicate in the person’s cells nor integrate into the cell’s native genetic material.

Vyjuvek is supplied as a 1.0mL biological suspension in a single dose vial at a nominal concentration of 5×10⁹ PFU/mL (PFU = plaque forming units). The excipient gel is supplied as a 1.5 mL fill volume in a separate single-use vial. The suspension is mixed with the gel immediately before administration.

Once mixed, Vyjuvek gel consists of 5.0×10⁹ PFU in a volume of 2.5 mL. Neither the biological suspension nor the excipient gel contain preservatives.

Once applied to wounds the modified HSV-1 vector transduces both keratinocytes and fibroblasts and deposits the active ingredient of Vyjuvek, beremagene-geperpavec-svdt into the nucleus of these cells.

• This initiates the transcription of the encoded human COL7A1 and results in the production and secretion of mature COL7 which forms anchoring fibrils, essential for maintaining the integrity of the skin.

Storage

Store the Vyjuvet carton at -15°C to -25°C (5°F to -13°F). If a freezer is not available, the carton can be
refrigerated (2º to 8ºC (35.6º to 46.4ºF)) for up to 1 month.

• Before use, Vyjuvek requires mixing into excipient gel

Once Vyjuvek gel and biologic suspension have been mixed, they should be applied within 8 hours if kept at room temperature or applied within 48 hours if kept in the refrigerator.

Who makes Vyjuvek?

Krystal Biotech, Inc. manufactures Vyjuvek.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer