The first and only FDA-approved topical medication for molluscum contagiosum that can be applied at home or on the go1-3
ZELSUVMI may reduce the need for passive watch-and-wait approaches or procedural in-office methods1,3
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Proven efficacy with an established safety profile
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Convenient, at-home or on-the-go application
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Proven in the largest clinical trial of molluscum
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Appropriate for use in sensitive areas. Do not use ZELSUVMI near or in the eyes, mouth, or vagina
ZELSUVMI is a novel, topical nitric oxide–releasing gel for treating molluscum at diagnosis1,3
ZELSUVMI stably releases nitric oxide at the site of application, thus minimizing systemic exposure.3
Nitric oxide is an endogenous small molecule that plays a role in localized innate immunity and inhibits viral replication.3-6
Nitric oxide may help accelerate the appearance of the beginning-of-the end (BOTE) sign, a positive indication the molluscum infection is resolving.4,6,7
The mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown.1
The MOA of ZELSUVMI
Understanding BOTE4
- It is a sign of the host immune response and positive indication that viral infection is improving
- Not a medication-related adverse effect that would warrant discontinuation or a secondary bacterial infection requiring treatment
- Not all patients will experience this as their molluscum infection resolves
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INDICATION
ZELSUVMI is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 1 year of age and older.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. 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 ZELSUVMI and initiate appropriate therapy.
ADVERSE REACTIONS
The most commonly reported adverse reactions (incidence ≥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%). Other adverse reactions include pyrexia (2.2%), vomiting (1.3%), and upper respiratory tract infection (1.2%).
USE IN SPECIFIC POPULATIONS
Pregnancy: 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.
Lactation: There are no data on the presence of berdazimer in human or animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZELSUVMI and potential adverse effects on the breastfed child.
Pediatric: The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may request medical information and report adverse events or product complaints to Pelthos Inc. by calling 1-855-330-7546 or sending an email to medinfo@pelthos.com.
Please see the full Prescribing Information and Instructions for Use for ZELSUVMI.
References: 1. ZELSUVMI™ (berdazimer) topical gel, Prescribing Information. LNHC, Inc., Durham, NC; 2024. 2. Keam S. Berdazimer topical gel, 10.3%: first approval. Drugs. 2024;84(3):363-368. 3. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878. 4. Maeda-Chubachi T, Hebert D, Messersmith E, et al. SB206, a nitric oxide-releasing topical medication, induces the beginning of the end sign and molluscum clearance. JID Innov. 2021;1(3):100019. doi:10.1016/j.xjidi.2021.100019 5. Colasanti M, Persichini T, Venturini G, et al. S-nitrosylation of viral proteins: molecular bases for antiviral effect of nitric oxide. IUBMB Life. 1999;48(1):25-31. 6. Ward BM, Riccio DA, Cartwright M, Maeda-Chubachi T. The antiviral effect of berdazimer sodium on molluscum contagiosum virus using a novel in vitro methodology. Viruses. 2023;15(12):2360. doi:10.3390/v15122360 7. Han H, Smythe C, Yousefian F, et al. Molluscum contagiosum virus evasion of immune surveillance: a review. J Drugs Dermatol. 2023;22(2):182-189.