Berdazimer (Topical) (Monograph)

Drug class: Antivirals

Introduction

Berdazimer is a nitric oxide (NO) releasing agent

Uses for Berdazimer (Topical)

Berdazimer has the following uses:

Berdazimer gel is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.

Berdazimer (Topical) Dosage and Administration

General

Berdazimer is available in the following dosage form(s) and strength(s):

Topical gel: 10.3% berdazimer supplied as 2 tubes: Tube A contains berdazimer gel and Tube B contains hydrogel. The drug is also supplied with a dosing guide.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adult and Pediatric Dosage

• For topical use only and not for ophthalmic, oral, or intravaginal use.

• Dispense equal amounts (0.5 mL) from Tube A and Tube B on the dosing guide.

• Mix together on the dosing guide.

• Immediately apply a thin layer of berdazimer gel. Allow the gel to dry for 10 minutes after application.

• Apply once daily to each MC lesion for up to 12 weeks.

Cautions for Berdazimer (Topical)

Contraindications

None.

Warnings/Precautions

Warnings

Application Site Reactions

Application site reactions, including allergic contact dermatitis, have occurred in patients treated with berdazimer. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling, or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue berdazimer and initiate appropriate therapy.

Specific Populations

Pregnancy

There are no available data on 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 the bioavailability of berdazimer following oral administration is significantly higher than topical application. The available data do not allow the calculation of 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.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Lactation

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.

Pediatric Use

The safety and effectiveness of berdazimer for the topical treatment of MC 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 subjects of which 1575 were pediatric subjects with MC (904 were exposed to berdazimer; 29 subjects were less than 2 years of age, including one subject less than 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.

Geriatric Use

Of the total number of berdazimer-treated subjects in clinical studies for MC, 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 subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

Common Adverse Effects

The most commonly reported adverse reactions (≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%).

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments.

Actions

Mechanism of Action

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

Advice to Patients

• Advise the patient or caregiver to read the FDA-approved patient labeling.

• Advise patients to discontinue berdazimer and seek medical attention immediately if signs or symptoms of application site reactions lasting more than 24 hours occur.

• Advise patients that berdazimer is for external use only and is not for ophthalmic, oral, or intravaginal use.

• Inform patients that berdazimer is supplied with two gel components that must be mixed together on the supplied dosing guide immediately before application.

• Instruct patients not to premix or store mixed berdazimer.

• Advise patients to wash hands after applying berdazimer (unless hands are being treated) and avoid transfer of the product to other areas of the skin, including the eye.

• Instruct patients to carefully follow the instructions for preparing and administering berdazimer in the FDA-approved patient labeling.

Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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