Berdazimer (Topical) (Monograph)

Brand name: Zelsuvmi
Drug class: Antivirals

Introduction

Nitric oxide (NO) releasing agent.

Uses for Berdazimer (Topical)

Molluscum Contagiosum

Topical treatment of molluscum contagiosum in adults and pediatric patients ≥1 year of age.

Several treatment options are available for molluscum contagiosum including curettage, cryotherapy, and chemical agents (podophyllin, tretinoin, cantharidin, trichloroacetic acid, liquified phenol, silver nitrate, tincture of iodine, or potassium hydroxide). Availability of berdazimer gel provides another treatment option.

Berdazimer (Topical) Dosage and Administration

General

Patient Monitoring

Monitor for pain, pruritus, swelling, or erythema at the application site; such symptoms site lasting longer than 24 hours may indicate allergic contact dermatitis.

Administration

Topical Administration

Administer topically as a 10.3% gel. For topical use only; not for ophthalmic, oral, or intravaginal use.

Supplied in a carton containing 2 gel tubes. Tube A contains berdazimer gel and Tube B contains hydrogel; a dosing guide is also supplied.

Mix together equal amounts of gel from tube A and tube B on the dosing guide before application.

Do not mix gels directly on skin or in palm of hand. Only mix gels on dosing guide to ensure the gels are measured accurately and mixed thoroughly.

Immediately apply an even thin layer of mixed berdazimer gel to each clean, dry molluscum contagiosum lesion.

Wash hands before and after application, unless hands are being treated, and allow gel to dry for 10 minutes.

Use water and mild soap to remove remaining gel from dosing guide.

Avoid application to uninvolved skin and avoid transfer of applied mixed berdazimer gel to other areas, including the eye.

Avoid swimming, bathing, or washing for 1 hour after application of mixed berdazimer gel.

Apply immediately after preparation. Do not premix or store mixed berdazimer gel.

Dosage

Dosage of berdazimer sodium is expressed in terms of berdazimer.

Pediatric Patients

Molluscum Contagiosum

Topical

≥1 year of age: Dispense equal amounts (0.5 mL) of gel from tube A and tube B on the dosing guide. Immediately apply the mixed gel as an even thin layer once daily to each molluscum contagiosum lesion for up to 12 weeks.

Adults

Molluscum Contagiosum

Topical

Dispense equal amounts (0.5 mL) of gel from tube A and tube B on the dosing guide. Immediately apply the mixed gel as an even thin layer once daily to each lesion for up to 12 weeks.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Berdazimer (Topical)

Contraindications

None.

Warnings/Precautions

Application Site Reactions

Application site reactions, including allergic contact dermatitis, reported.

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

No available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Lactation

No data on the presence of berdazimer or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production.

Consider the developmental and health benefits of breastfeeding 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

Safety and effectiveness established in pediatric patients ≥1 year of age.

Geriatric Use

It is unknown if patients ≥65 years of age respond differently from younger patients.

Common Adverse Effects

Most common adverse reactions (≥1%): application site reactions, including pain (e.g., burning, stinging sensations), erythema, pruritus, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, infection.

Drug Interactions

No formal drug interaction studies performed. Drug interaction studies were not deemed necessary due to low systemic exposure.

Berdazimer (Topical) Pharmacokinetics

Absorption

Plasma Concentrations

Systemic exposure characterized by plasma hydrolyzed MAP3 (hMAP3), a structural marker for the drug, and by nitrate levels. hMAP3 was detected after 15 days in a few patients. Time to maximum concentration of hMAP3 was 2 hours.

Mean plasma nitrate levels were similar on days 1 and 15 and remained relatively flat from baseline through 6 hours post-application.

Distribution

Studies evaluating distribution of berdazimer not conducted.

Elimination

Studies evaluating metabolism or excretion of berdazimer not conducted.

Stability

Storage

Topical

Gel

Store in refrigerator between 2–8ºC until dispensed. Discard 60 days after removal from refrigeration. After dispensing, store at room temperature (20–25ºC) in a dry location. Keep away from open flames. Do not freeze.

Actions

Nitric oxide releasing agent.
Consists of 2 gel components, a berdazimer sodium gel and a proton-donating hydrogel. When the gels are mixed, nitric oxide is released.
Mechanism of action in 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 gel is for external use only and is not for ophthalmic, oral, or intravaginal use.
Instruct patients to carefully follow the instructions for preparing and administering berdazimer in the FDA-approved patient labeling. 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 before and after applying berdazimer (unless hands are being treated) and avoid transfer of the product to other areas of the skin, including the eye.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed.
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.