Molluscum can be treated in the comfort of home or on the go1,2
Once-daily ZELSUVMI is the first and only prescription gel for at-home management of molluscum contagiosum that may reduce the need for multiple office visits1,2
ZELSUVMI is supplied as two tubes plus one reusable Dosing Guide1
Tube A contains ZELSUVMI gel
Tube B contains hydrogel
The reusable Dosing Guide helps ensure proper mixing and accurate dosing
ZELSUVMI is applied in just 3 simple steps
To activate ZELSUVMI, the gels in Tubes A and B must be mixed before application1
Dispense equal amounts (0.5 mL) of gel from Tube A and Tube B on the Dosing Guide. Immediately put the caps back on Tube A and Tube B, securing tightly.
Mix gels together on the Dosing Guide using a fingertip.
Apply in a thin, even layer to each molluscum lesion once a day for up to 12 weeks. Wash hands after applying ZELSUVMI, unless hands are being treated.
Wait at least 10 minutes after applying gel before putting clothes on the skin to allow ZELSUVMI to dry.
- Patients should avoid swimming, bathing, or washing for 1 hour after applying ZELSUVMI
Full instructions on how to prepare and apply ZELSUVMI
Storing ZELSUVMI1
Prior to dispensing: Store ZELSUVMI in a refrigerator between 36°F and 46°F (2°C and 8°C)
After dispensing: Store ZELSUVMI at room temperature, between 68°F and 77°F (20°C and 25°C) in a dry location
Discard 60 days after ZELSUVMI is dispensed
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.