Zelsuvmi gel

Pronunciation: zel-SOOV-mee
Generic name: berdazimer 10.3%
Brand name: Zelsuvmi
Dosage form: topical gel
Drug class: Miscellaneous topical agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 28, 2024.

What is Zelsuvmi?

Zelsuvmi gel (berdazimer 10.3%) is a prescription medicine used to treat the viral skin condition, molluscum contagiosum (MC) in adults and children aged 1 year and older. Zelsuvmi gel is applied once a day to the affected MC lesions for up to 12 weeks.

Zelsuvmi (berdazimer 10.3%) gel releases nitric oxide, which has been shown to have antiviral effects, although exactly how Zelsuvmi works to treat MC is unknown. FDA approval of Zelsuvmi was based on the B-SIMPLE4, a phase 3 clinical trial (n=891) that reported complete clearance of MC lesions in 32.4% of patients assigned Zelsuvmi compared to only 19.7% assigned an inactive vehicle gel.

Zelsuvmi was FDA-approved on January 5, 2024.

Zelsuvmi side effects

The most common side effects of Zelsuvmi occur where you apply the gel to the skin and may include:

• swelling
• burning
• breakdown of the outer layer of the skin (erosion)
• stinging
• lightening or darkening of the skin
• redness
• blisters
• itching
• irritation
• peeling or flaking
• infection
• itchy, dry skin rash.

Related/similar drugs

Serious side effects and warnings

Zelsuvmi may cause serious side effects, including severe reactions to the areas of the skin where you apply the gel. Stop using Zelsuvmi and tell your healthcare provider right away if your skin becomes painful, burns, stings, itches, swells, or looks very red for more than 24 hours after treatment.

Zelsuvmi is for use on the skin (for topical use) only. Do not use near or in your eyes, mouth, or vagina.

It is not known if Zelsuvmi is safe and effective in children under 1 year of age.

These are not all the possible side effects of Zelsuvmi. Call your doctor for medical advice about side effects. You may report side effects to LNHC, Inc. at 1-800-499-4468 or www.novan.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Before using Zelsuvmi, tell your healthcare provider about all your medical conditions, including if you:

• have other skin problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Zelsuvmi will harm an unborn baby. Tell your doctor if you are pregnant or become pregnant.

Breastfeeding

It is not known if Zelsuvmi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How should I use Zelsuvmi?

Read the Instructions for Use in the Zelsuvmi Medication Guide for detailed information about how to properly prepare and apply Zelsuvmi. Use it exactly as your healthcare provider tells you to use it.

The Zelsuvmi carton contains 2 tubes that you mix together and a dosing guide.

• 1 tube contains berdazimer gel (Tube A).
• 1 tube contains hydrogel (Tube B).

The gels contained in Tube A and Tube B must be mixed together on the Zelsuvmi Dosing Guide before you apply Zelsuvmi to your skin.

• The dosing guide has 2 lanes – a blue one for Tube A and a yellow one for Tube B. Squeeze gel from Tube A onto the blue lane to cover the entire area of the lane. Screw the cap back on. Repeat with tube B as per the dosing guide.
• Do not mix the gels until you are ready to apply. Use a clean fingertip to thoroughly mix the 2 gels in the center of the dosing guide using a circular motion for about 20 seconds. Clumps may form but these are normal. Apply a thin layer of the mixed gel right away to the MC bumps. All bumps should be treated with gel.
• Apply once each day to each lesion for up to 12 weeks.
• Wash your hands after applying the gel, unless your hands are being treated for MC. If someone else applies Zelsuvmi for you, they should wash their hands after applying it.
• Do not apply near or in your eyes, mouth, vagina, or areas of your skin where you do not have MC.
• Allow Zelsuvmi to dry for 10 minutes and do not swim, take a bath or shower, or wash the areas where you applied Zelsuvmi for at least 1 hour.

What happens if I miss a dose?

If you miss a dose of Zelsuvmi, apply the missed dose right away. If it is almost time for your next dose, skip that dose and just go back to your regular dosing schedule. Do not apply 2 doses at once.

What happens if I overdose?

If you apply too much Zelsuvmi, ring your healthcare provider right away. Always use the dosing guide to ensure the gels are measured accurately.

What other drugs will affect Zelsuvmi?

Tell your healthcare provider about all your medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

No formal drug interaction studies have been done with Zelsuvmi. See the Zelsuvmi Prescribing Information for more information about drug interactions.

See the prescribing information for a full list of interactions.

Storage

Before dispensing, your healthcare provider will store Zelsuvmi in a refrigerator between 2°C and 8°C (36°F and 46°F) before dispensing to you. Do not freeze.

After dispensing, you can store Zelsuvmi at home at room temperature, between 20°C to 25°C (68°F and 77°F) in a dry location. Discard 60 days after removal from refrigeration. Write the “Discard after” date in the space provided on the carton.

Zelsuvmi contains alcohol and should be kept away from fire. Do not smoke after applying Zelsuvmi.

Zelsuvmi gel ingredients

Zelsuvmi Tube A

• Active ingredient: berdazimer sodium 10.3%
• Inactive ingredients: cyclomethicone, hexylene glycol, hydroxypropyl cellulose, and isopropyl alcohol

Zelsuvmi Tube B

• Inactive ingredients: benzoic acid, carboxymethylcellulose sodium, cyclomethicone, ethanol, glycerin, potassium phosphate monobasic, and purified water

Who makes Zelsuvmi?

EPIH SPV, LLC. manufactures Zelsuvmi.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer