Vyjuvek (beremagene geperpavec-svdt)

It isessential 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. The gel prepared at the pharmacy, should be applied by a healthcare professional, 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 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).

Table 1: Maximum Weekly Dose by Age

Age Range Maximum Weekly Dose Maximum Weekly Volume (plaque forming units; (mL) PFU) <3 years old 2x109 1 >= 3 years old 4x109 2

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 (width of a fingertip). The table below provides a reference on dose per approximate size of the wound.

Table 2: Dose per Approximate Size of Wound

Wound Area (cm2) Dose (PFU) Volume (mL) <20 4x108 0.2 20 to <40 8x108 0.4 40 to 60 1.2x109 0.6

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 treat all wounds each week. Apply gel to wounds until they are closed before selecting new wound(s) to treat. Weekly treatment of previously treatedwounds should be prioritized if they re-open.

See full prescribing information for instructions on preparation and handling, and administration.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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

There are no severe adverse reactions for this drug.

More Frequent

• Chills
• Cough
• Erythema
• Pruritus of skin
• Rhinorrhea
• Skin rash

No enhanced messaging available.

The safety and effectiveness of beremagene geperpavec-svdt have been established in pediatric patients with dystrophic epidermolysis bullosa (DEB). The use in pediatric patients (0 to 16 years of age) was supported byevidence from adequate and well-controlled study which included 19 pediatric patients 1 year of age and older.

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.

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.

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