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Berdazimer: Pediatric drug information

Berdazimer: Pediatric drug information
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For additional information see "Berdazimer: Drug information" and "Berdazimer: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Therapeutic Category
  • Antiviral Agent, Topical
Dosing: Pediatric
Molluscum contagiosum

Molluscum contagiosum:

Note: Berdazimer is supplied as two tubes that must be mixed just prior to administration of each dose using the supplied dosing guide.

Children and Adolescents: Topical: Apply a thin layer of the mixed gel to each lesion once daily for up to 12 weeks.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Dosage adjustment is unlikely due to low systemic absorption.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. Dosage adjustment is unlikely due to low systemic absorption.

Dosing: Adult

(For additional information see "Berdazimer: Drug information")

Molluscum contagiosum

Molluscum contagiosum: Topical: Apply an even, thin layer once daily to each lesion for up to 12 weeks.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for children, adolescents, and adults.

>10%: Local: Application-site pain (≤12%)

1% to 10%:

Local: Application-site dermatitis (≤3%), application-site edema (≤2%), application-site erythema (5% to 6%), application-site pruritus (2% to 4%), application-site vesicles (≤1%), local skin discoloration (≤1%; application site), local skin exfoliation (≤3%; application site)

Miscellaneous: Fever (2%)

<1%:

Dermatologic: Skin erosion (application site)

Local: Application-site irritation

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Application-site reactions: May cause application-site reactions, including allergic contact dermatitis. If erythema, pain, pruritus, or swelling occurs at the application site for >24 hours, discontinue and initiate appropriate therapy.

Dosage form specific issues:

• Flammable contents: Contains alcohol; keep away from open flame.

Product Availability

Zelsuvmi: FDA approved January 2024; availability anticipated in 2024.

Administration: Pediatric

Topical: Topical use only; not for ophthalmic, oral, or intravaginal use. Avoid application to open wounds or unaffected skin. Wash hands prior to use. Berdazimer is supplied in two tubes that must be mixed using the supplied dosing guide card just prior to each application; do not mix directly on skin or in palm of hand; do not premix. Squeeze contents of tube A (blue) to cover entire blue dosing line, then squeeze contents of tube B (yellow) to cover entire yellow dosing line on dosing guide. Wipe any excess gel that leaks from tubes with a tissue or cloth; ensure the correct cap is replaced on the coordinating colored tube. Using fingertips, mix the two gels together in the center of the dosing guide using a swirling motion while slowly counting to 20. Some clumps may occur during mixing, which is normal. Immediately after mixing, apply mixed gel to all molluscum bumps (lesions), paying particular attention to new, hard-to-reach, or hard-to-see areas. If gel runs out before all affected areas are covered, wipe dosing guide with a dry tissue and repeat mixing process. Wash hands after application, except for areas on hands that are being treated. Wait 10 minutes after application before putting on clothes to allow the gel to dry. Wait at least 1 hour after application before swimming, showering, bathing, or washing. After all areas are treated, wash dosing guide with mild soap and water and dry.

Administration: Adult

Topical: For topical use only; not for intravaginal, ophthalmic, or oral use. Mix together equal amounts of gel from tube A and tube B on the dosing guide (do not mix directly on skin or in palm of hand) immediately prior to applying; do not premix. Wipe any excess gel that leaks from tubes with a tissue or cloth; ensure the correct cap is replaced on the coordinating colored tube. Apply an even, thin layer to clean, dry skin. After applying, allow gel to dry for 10 minutes before covering with clothes. Do not apply to open wounds. Avoid applying to uninvolved skin or transferring to other areas, including the eye. Do not bathe, shower, swim, or wash for 1 hour after application. Wash hands before and after use, unless hands are being treated. Discard any amount not used; do not store for later use. Clean dosing guide with mild soap and water after use.

Storage/Stability

Prior to dispensing, store between 2°C and 8°C (36°F and 46°F). After dispensing, store between 20°C and 25°C (68°F and 77°F). Do not freeze and keep away from open flame. Discard any amount not used 60 days after removal from the refrigerator.

Use

Treatment of molluscum contagiosum (FDA approved in ages ≥1 year and adults).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

There are no known significant interactions.

Pregnancy Considerations

Adverse events were observed in animal reproduction studies following oral administration.

Monitoring Parameters

Monitor for allergic dermatitis and application site reactions.

Mechanism of Action

Berdazimer is a nitric oxide–releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.

  1. Zelsuvmi (berdazimer) [prescribing information]. Wilmington, DE: EPIH SPV LLC; January 2024.
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