Zelsuvmi (berdazimer sodium)

Dosage of berdazimer sodium is expressed in terms of berdazimer.

Berdazimer sodium is applied topically to the skin as a 10.3% gel. The gel is for topical use only and is not for ophthalmic, oral, or intravaginal use.

Berdazimer is supplied in a carton containing 2 tubes; one tube contains berdazimer gel (tube A) and the other tube contains hydrogel (tube B). A dosing guide is also supplied to aid in preparation of the drug. To prepare the gel for administration, mix together equal amounts (0.5 mL) of gel from tube A and tube B in a circular motion on the dosing guide before application. Use the dosing guide to ensure that the gels are measured accurately and mixed thoroughly. Do not mix gels directly on skin or in the palm of hand. Immediately apply an even thin layer of mixed berdazimer gel to each clean, dry molluscum contagiosum lesion; avoid application to uninvolved skin. Wash hands after applying the gel, unless the hands are being treated, and allow the gel to dry for 10 minutes after application. Use water and mild soap to remove any remaining gel from the dosing guide. Avoid swimming, bathing, or washing for 1 hour after application. Do not premix or store the mixed berdazimer gel; the drug should be applied immediately after preparation.

Store the berdazimer product in a refrigerator between 2-8oC until dispensed. Discard 60 days after removal from refrigeration. After dispensing, store berdazimer at room temperature (between 20-25oC) in a dry location. Berdazimer contains alcohol and should be kept away from open flames. Do not freeze.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date with berdazimer. Drug interaction studies were not deemed necessary due to low systemic exposure.

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 (>=1%) reported with berdazimer gel in clinical studies were application site reactions, including pain (e.g., burning, stinging sensations), erythema, pruritus, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, and infection.

There are no severe adverse reactions for this drug.

More Frequent

• Acute pain at drug application site
• Allergic dermatitis
• Application site infection
• Application site rash
• Application site skin reactions
• Dermatitis due to topical drug
• Erythema
• Exfoliative dermatitis
• Fever
• Pruritus of skin

Less Frequent

• Blistering skin
• Dyschromia
• Skin irritation
• Upper respiratory infection
• Vomiting

No enhanced messaging available.

The safety and effectiveness of berdazimer for the topical treatment of molluscum contagiosum have been established in pediatric patients 1 year of age and older. Use of berdazimer for this indication is supported by data from 3 randomized, vehicle-controlled, double-blind trials involving 1596 patients of which 1575 were pediatric patients with molluscum contagiosum (904 were exposed to berdazimer; 29 patients were <2 years of age, including one patient <1 year of age, and 875 were 2 to 17 years of age). The safety and effectiveness of berdazimer have not been established in pediatric patients younger than 1 year of age.

There are no available data on topical berdazimer use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of berdazimer to pregnant rats and rabbits increased malformations in the presence of severe maternal toxicity. The clinical relevance of this finding is unknown given that the bioavailability of berdazimer following oral administration is significantly higher than topical application. The available data do not allow relevant comparisons between the systemic exposure of berdazimer observed in animal studies and the systemic exposure that would be expected in humans after topical use of berdazimer.

There are no data on the presence of berdazimer or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for berdazimer and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Of the total number of berdazimer-treated patients in clinical studies for molluscum contagiosum, none were 65 to 74 years of age, and one was 75 years of age and older. Clinical studies of berdazimer did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult subjects.