Molluscum contagiosum: Topical: Apply an even, thin layer once daily to each lesion for up to 12 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Berdazimer: Pediatric drug information")
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.
There are no dosage adjustments provided in the manufacturer's labeling. Dosage adjustment is unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. Dosage adjustment is unlikely due to low systemic absorption.
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
There are no contraindications listed in the manufacturer's labeling.
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.
Zelsuvmi: FDA approved January 2024; availability anticipated in 2024.
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.
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.
Molluscum contagiosum: Treatment of molluscum contagiosum in adults and pediatric patients ≥1 year of age.
None known.
There are no known significant interactions.
Adverse events were observed in animal reproduction studies following oral administration.
It is not known if berdazimer is present in breast milk following topical application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Berdazimer is a nitric oxide–releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.