Safety profile was established in clinical trials1,2
Nearly all treatment-emergent adverse events (TEAEs) were rated as mild or moderate in intensity2
- <1% of patients experienced a severe application-site TEAE2
- Mean local skin reaction composite scores were highest at Weeks 2 and 4 and then declined2
- No patient treated with ZELSUVMI experienced keloidal or hypertrophic scars during the full 24-week study period2
The most frequent TEAEs affecting ≥5% of patients in either arm (Study 1)2
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| ZELSUVMI n=444 |
Vehicle n=447 |
|
|---|---|---|
| Application-site pain* | 18.7% | 5.1% |
| Application-site erythema | 11.7% | 1.3% |
| Application-site pruritus | 7.4% | 1.1% |
| Application-site exfoliation | 6.1% | 0% |
| Application-site dermatitis | 5.9% | 0.7% |
| Application-site scar† | 4.7% | 6.3% |
The safety of ZELSUVMI was studied in 916 patients across 3 clinical trials. The most commonly reported TEAEs (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%).1
Low discontinuation rate
- 4.1% (18/444) discontinuation rate due to adverse events in the ZELSUVMI group vs 0.7% (3/447) in the vehicle group2
See Prescribing Information for additional adverse reactions.
*Application-site pain also includes application-site burning and stinging.1
†The FDA required that temporary epidermal atrophy from the resolution of a space-occupying lesion be captured as a scar.2
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. 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.