Frequently asked questions about ZELSUVMI

Molluscum is a common, highly contagious, and burdensome condition. If left untreated, lesions can spread to other parts of the body and to other people. A molluscum infection can last for many months or even years, remaining contagious with active lesions.^1-4 Because the infection can spread, some healthcare providers recommend avoiding scratching, not sharing towels or clothing, and covering bumps during activities that involve skin-to-skin contact. Additionally, parents/caregivers may have to take time off from work/school for multiple doctor visits and treatment.⁵ Find out more about the impact of molluscum.

ZELSUVMI is the first and only FDA-approved treatment that can be applied at home or on the go. As a novel, topical treatment, ZELSUVMI stably releases nitric oxide—an endogenous small molecule that plays a role in localized innate immunity and inhibits viral replication. The mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown.^6-11 Learn more about ZELSUVMI.

ZELSUVMI is applied to each molluscum lesion once daily for up to 12 weeks. Patients should treat any new lesions that appear and continue with treatment for the full 12 weeks.^6,7 Patients should be reminded to refill their prescription to ensure that all lesions are treated.

In a double-blind, vehicle-controlled, phase 3 study in 891 patients, 32.4% of patients treated with ZELSUVMI achieved the primary efficacy end point of complete clearance of molluscum lesions at Week 12 vs 19.7% with vehicle. Additionally, nearly twice as many patients treated with ZELSUVMI experienced a complete or near complete response at Week 12 vs vehicle (43.0% vs 23.9%, respectively). At Week 4, there was a greater percent reduction in lesion count with ZELSUVMI vs vehicle (27.1% vs 5.6%, respectively).^6,7 See more information on study results.

In the pivotal clinical trial with ZELSUVMI, new lesions were included in the total lesion count made at each visit, regardless of location, including areas treated and untreated with drug. Specifically, active (palpable) molluscum lesions were counted at baseline and each study visit through Week 12 by the same assessor, if possible, using a body map for documentation. Only treatable lesions, defined as active (palpable) molluscum lesions at least 2 cm away from the ocular region, were counted.⁷

The ZELSUVMI study population had a mean duration of disease of 12.0 months (range: 0.2 to 153.3 months) for the ZELSUVMI arm and 13.1 months (range: 0 to 192.8 months) for the vehicle arm. Approximately half of the patients in both arms had also presented with the beginning-of-the-end (BOTE) sign at baseline. Since molluscum is a self-limiting condition, it may be that some participants had lesions that resolved spontaneously during the clinical trial.⁷

In three double-blind, vehicle-controlled clinical trials that included 1596 adult and pediatric subjects treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks, the most commonly reported adverse reactions (incidence ≥1%) were 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%). Other adverse reactions included pyrexia (2.2%), vomiting (1.3%), and upper respiratory tract infection (1.2%).⁶ These are not all of the possible side effects of ZELSUVMI.

There are no available data with use of ZELSUVMI in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.⁶

The safety and effectiveness of ZELSUVMI for the topical treatment of molluscum have been established in pediatric patients 1 year of age and older. Use of ZELSUVMI for this indication is supported by data from three randomized, vehicle-controlled, double-blind trials involving 1596 subjects, of whom 1575 were pediatric subjects with molluscum (904 were exposed to ZELSUVMI; 29 subjects were younger than 2 years of age). The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.⁶

There are currently no data available on the use of ZELSUVMI in patients with sexually transmitted molluscum since these patients were excluded from the clinical trial.⁷ ZELSUVMI should not be applied near or in the eyes, mouth, or vagina.⁶

ZELSUVMI is supplied as two tubes and comes with one reusable Dosing Guide that is used to mix the two gels together. Tube A with a blue label contains 14 grams of berdazimer gel and Tube B with a yellow label contains 17 grams of hydrogel. Patients should be instructed to NOT throw out the Dosing Guide—just wash and reuse it for every application of ZELSUVMI.⁶

ZELSUVMI should be applied to each molluscum lesion once daily with just 3 simple steps.⁶

1. Squeeze equal amounts of gel from Tube A and Tube B onto the Dosing Guide as marked.
2. Using a fingertip, mix the gels on the Dosing Guide for 20 seconds to activate ZELSUVMI.
3. Apply ZELSUVMI as a thin, even layer directly to each molluscum bump.

Patients should be instructed to apply to the molluscum only and avoid getting ZELSUVMI on surrounding skin. View the ZELSUVMI Application Video for more information.

ZELSUVMI may be used on the face. However, patients should not treat bumps close to the eyes or get the gel in the eye. In the ZELSUVMI clinical trial, treatable lesions were defined as active (palpable) molluscum lesions at least 2 cm away from the ocular region. If gel gets in the eye, rinse with water. Do not use ZELSUVMI in the mouth or vagina.^6,7

Wash hands after applying ZELSUVMI, unless the hands were treated. Patients should wait at least 10 minutes before putting clothes on the skin to allow ZELSUVMI to dry. Additionally, patients should avoid swimming, bathing, or washing for 1 hour after applying ZELSUVMI.⁶

Prior to dispensing, ZELSUVMI should be stored in a refrigerator. After dispensing, patients should be instructed to store ZELSUVMI at room temperature between 68°F and 77°F (20°C and 25°C) in a dry location. Patients should throw away any ZELSUVMI that is not used within 60 days after receiving it.⁶

Many health plans offer coverage for ZELSUVMI, although some may require prior authorization before treatment can be approved. It is important to verify coverage with the patient’s insurance provider. Please note that some payers may indicate that ZELSUVMI is not on formulary. In these situations, a formulary exception request and/or prior authorization is often available and may provide a pathway to coverage.

Yes. With the ZelsuvmiGO program, patients with commercial insurance may be eligible to receive ZELSUVMI for as little as $0. Visit zelsuvmi.com/support for more information.

ZELSUVMI may be dispensed through ASPN Pharmacy, online pharmacies, or local retail pharmacies. Contact your sales representative for additional support and resources, such as the prior authorization checklist.