zelsuvmi
Zelsuvmi (Berdazimer Sodium) is a medication used to treat Molluscum Contagiosum.
Berdazimer Sodium · by Lnhc
Key facts
- Active ingredient
- Berdazimer Sodium
- Form
- Kit
- Strength
- Berdazimer Sodium EQ 10.3% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- molluscum contagiosum
- Manufacturer
- Lnhc
- FDA application
- NDA217424
What is Zelsuvmi?
From the FDA label:ZELSUVMI (berdazimer) topical gel, 10.3%, a nitric oxide releasing agent, contains the drug substance berdazimer sodium, a white to off white powder with the chemical name poly[{[3-(methylamino)propyl]silasesquioxane}-co-{[3-(1-methyl-2-nitroso2-oxidohydrazin-1 yl)propyl]silasesquioxane}-co-silicate (1:3:6 x)], partially hydrolyzed (Si : OH ~ 10 : 5), and the following structural and empirical formula: Structural Formula: * Denotes shared oxygen atom between bonded constituents; resulting bonds are Si-O-Si or Si‑OH Empirical formula: [(C4H9N3NaO3.5Si)3(C4H10NO1.5Si)1(SiO2)6(HO0.5)5] 0.1n Due to the insoluble nature of berdazimer sodium, the molecular formula, molecular mass, and average molecular weight range cannot be determined. ZELSUVMI (berdazimer) topical gel is an opaque white to off-white gel containing 10.3% berdazimer (equivalent to 10.9% berdazimer sodium). ZELSUVMI is supplied as two gel components that are mixed before administration: Tube A (14 g): an opaque white to off-white gel containing 240 mg of berdazimer sodium per gram of gel and the inactive ingredients cyclomethicone, hexylene glycol, hydroxypropyl cellulose, and isopropyl alcohol. Tube B (17 g): a translucent to opaque white to off-white gel containing the inactive ingredients benzoic acid, carboxymethylcellulose sodium, cyclomethicone, ethanol (13% v/v), glycerin, potassium phosphate monobasic, and…
How to use
Dispense equal amounts from Tube A and Tube B per the dosing guide. ( 2.2 ) Mix together and immediately apply a thin layer of ZELSUVMI. ( 2.2 ) Apply once daily to each MC lesion for up to 12 weeks. ( 2.2 ) For topical use only and not for ophthalmic, oral, or intravaginal use. ( 2.2 ) 2.1 Important Preparation and Administration Instructions ZELSUVMI is supplied in a carton containing the following: Tube A containing berdazimer gel Tube B containing hydrogel Dosing guide Mix together equal amounts of gel from Tube A and Tube B before application [see Dosage and Administration (2.2) ] . Do not premix or store mixed ZELSUVMI. Instruct the patient to refer to the ZELSUVMI “Instructions for Use” for detailed instructions on the preparation and administration of ZELSUVMI [see Instructions for Use] . 2.2 Recommended Dosage and Administration 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 tightly. Mix together on the dosing guide. Immediately apply ZELSUVMI as an even thin layer. Apply ZELSUVMI once daily to each MC lesion for up to 12 weeks. Wash hands after applying ZELSUVMI, unless hands are being treated. Allow ZELSUVMI to dry for 10 minutes after application. Avoid application to uninvolved skin and avoid transfer of applied ZELSUVMI to other areas, including the eye. Avoid swimming,…
Side effects
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%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LNHC, Inc. at 1-855-330-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three double-blind, vehicle-controlled clinical trials (Trial 1, and Trial 2 and Trial 3, which were similarly designed to Trial 1), 1596 adult and pediatric subjects were treated with ZELSUVMI or vehicle gel topically once daily for up to 12 weeks [see Clinical Studies (14) ]. In these trials 3% of subjects were less than 2 years of age, and 96% of subjects were 2 to 17 years of age. The trial population included 51% male, 88% White, 6% Black, and 6% Other; for ethnicity, 21% of subjects identified as Hispanic/Latino, 78% as non-Hispanic/Latino, and 1% were not reported. Adverse reactions reported by ≥1% of subjects and…
Warnings
Important safety information
Application Site Reactions: Application site reactions, including allergic contact dermatitis, occurred. Discontinue ZELSUVMI and initiate appropriate therapy. ( 5.1 ) 5.1 Application Site Reactions 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.
Who should not take Zelsuvmi
None. None.
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Zelsuvmi treat?
- Zelsuvmi (Berdazimer Sodium) may be used to treat molluscum contagiosum, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Zelsuvmi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zelsuvmi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zelsuvmi?
- Zelsuvmi is marketed by Lnhc. You can see Lnhc's full profile, rating, and other products on pharmaranks.
- Is Zelsuvmi a brand-name or generic drug?
- Zelsuvmi is a brand-name product with the active ingredient Berdazimer Sodium.
- Is Zelsuvmi available over the counter?
- No. Zelsuvmi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zelsuvmi come in?
- Zelsuvmi is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Zelsuvmi FDA-registered?
- Zelsuvmi is on record with the U.S. FDA under application number NDA217424. You can verify this on its official FDA label.
- Is Zelsuvmi safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zelsuvmi. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zelsuvmi?
- Zelsuvmi's side effects are taken directly from its FDA label. From the label: 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%),… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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