ZELSUVMI
Generic Name/API: berdazimer
Manufacturer: EPIH SPV
Dosage Forms & Strength & Pack Size:
Topical gel: 10.3% berdazimer supplied as two tubes. Tube A contains berdazimer gel and Tube B contains hydrogel.
Storage:
Storage and Handling
• Prior to Dispensing: Store ZELSUVMI in a refrigerator between 2°C and 8°C (36°F and
46°F) until dispensed to the patient. Write the “Discard after” date in the space provided
on the carton.
• After Dispensing: Store ZELSUVMI at room temperature, between 20°C to 25°C (68°F
and 77°F) in a dry location.
• Product contains alcohol and should be kept away from open flame.
• Do not freeze.
• Discard 60 days after removal from refrigeration.
ZELSUVMI™, a first-in-class topical medication, is now FDA approved as the first novel drug* for the treatment of molluscum contagiosum.
ZELSUVMI™ Gel is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.
Important Safety Information:
Warnings: Application site reactions, including, allergic contact dermatitis occurred. Discontinue ZELSUVMI and initiate appropriate therapy.
Adverse Reactions: The most commonly reported adverse reactions (≥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%).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
