Beremagene Geperpavec Topical Dosage

Medically reviewed by Drugs.com. Last updated on Dec 4, 2023.

Usual Adult Dose for Epidermolysis Bullosa

Maximum weekly dose: Apply 3.2 x 10(9) plaque forming units (PFU) or 1.6 mL (total volume of prepared gel) topically to wound(s) once a week.

Recommended Dose Based On Wound Area:

• Less than 20 cm2: Apply 4 x 10(8) PFU or 0.2 mL topically once a week.
• 20 to less than 40 cm2: Apply 8 x 10(8) PFU or 0.4 mL topically once a week.
• 40 to 60 cm2: Apply 1.2 x 10(9) PFU or 0.6 mL topically once a week.
• Greater than 60 cm2: Calculate the total dose needed based on wound size until the maximum weekly dose is reached.

Comments:

• It may not be possible to apply gel to all wounds at each treatment visit.
• Apply gel to wound(s) until they are closed before selecting new wound(s) to treat.
• Prioritize weekly treatment to previously treated wounds if they re-open.

Use: For the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Usual Pediatric Dose for Epidermolysis Bullosa

6 months to less than 3 years of age:

• Maximum weekly dose: Apply 1.6 x 10(9) plaque forming units (PFU) or 0.8 mL (total volume of prepared product) topically to wound(s) once a week.

3 years of age or greater:

• Maximum weekly dose: Apply 3.2 x 10(9) PFU or 1.6 mL (total volume of prepared product) topically to wound(s) once a week.

Recommended Dose Based On Wound Area:

• Less than 20 cm2: Apply 4 x 10(8) PFU or 0.2 mL topically once a week.
• 20 to less than 40 cm2: Apply 8 x 10(8) PFU or 0.4 mL topically once a week.
• 40 to 60 cm2: Apply 1.2 x 10(9) PFU or 0.6 mL topically once a week.
• Greater than 60 cm2: Calculate the total dose needed based on wound size until the maximum weekly dose for age is reached.

Comments:

• It may not be possible to apply gel to all wounds at each treatment visit.
• Apply gel to would until they are closed before selecting a new wound to treat.
• Prioritize weekly treatment to previously treated wounds if they re-open.

Use: For the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 6 months

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should only be applied by a healthcare provider in a clinic or home setting.
• Wear protective gloves when assisting patient with dressings and handling disposal.
• In the event of an accidental exposure, flush with clean water for at least 15 minutes.
• Pre-mixed gel administration: Apply gel topically to selected wound(s) in droplets spaced evenly within wound (approximately 1 cm by 1 cm apart); resulting pattern should resemble a grid.
• Avoid touching administration syringe to patient skin during application.
• Once gel is applied, cover wound with hydrophobic dressing cut to a size slightly larger than the wound; then, place standard dressing over the hydrophobic dressing.
• Avoid direct contact with treated wounds and do not change wound dressing within approximately 24 hours after gel application.
• Missed dose: Apply gel as soon as possible and resume weekly dosing thereafter.

Storage requirements:

• Store drug carton at -15C to -25C (5F to -13F).
• If a freezer is not available, the carton can be refrigerated at 2C to 8C (35.6C to 46.4F) for up to 1 month.
• Administration syringes containing the drug gel may remain at room temperature at 20C to 25C (68F to 77F) for up to 8 hours.
• If immediate use is not possible, administration syringes can be stored for up to 48 hours in the refrigerator at 2C to 8C (35.6 to 46.4F).

Preparation techniques:

• The manufacturer product information should be consulted prior to product preparation.
• Follow universal biohazard precautions for handling; prepare in a pharmacy.
• This drug (a biological suspension) requires mixing into the excipient gel vial prior to application.
• Both the drug and excipient gel should thaw at room temperature for at least 20 minutes; visually inspect prior to use as excipient gel may take longer to thaw.
• Using a syringe, draw out 1 mL of the biological drug suspension vial and inject into the excipient vial; before removing syringe from excipient vial, draw out 1 mL of air.
• Vigorously mix excipient vial containing the biological suspension for 10 seconds to create final product.
• Insert a new syringe (the administration syringe) into excipient gel vial (final product) and withdraw 0.4 mL of drug gel. Disconnect syringe from needle (allowing needle to remain in vial) and cap syringe.
• Repeat with 3 more syringes (using needle remaining in vial) to achieve 1.6 mL if required.
• Once mixed, the final product should be used within 8 hours.

Patient advice:

• Avoid direct contact with treated wounds (e.g., touching and scratching) and dressings of treated wounds for approximately 24 hours following gel application.
• Wash hands and wear protective gloves when changing wound dressings.
• In the event of accidental exposure, patients and exposed individuals should clean the affected area.
• Disinfect bandages from the first dressing change with a virucidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide or less than 0.4% ammonium chloride.
• Dispose of the disinfected bandages in a separate sealed plastic bag in household waste.

Further information

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

Medical Disclaimer