Zelsuvmi

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

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 9, 2024.

What is Zelsuvmi?

Zelsuvmi (berdazimer 10.3%) is a topical gel preparation that can be applied to the skin by patients, parents, or caregivers at home for up to 12 weeks at a time to treat molluscum contagiosum (MC) in adults and children aged 1 year and older.

MC is a viral skin disease characterized by distinctive raised, skin-toned-to-pink-colored lesions called Mollusca that can cause pain, inflammation, itching, and bacterial infection. Zelsuvmi (berdazimer) is a nitric oxide-releasing agent, which has been shown to have antiviral effects, although how berdazimer works to treat MC is unknown. Approval 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.

Warnings

Application site reactions, including allergic skin reactions, are common where Zelsuvmi has been applied to your skin, but can also be severe. Stop using the gel and tell your healthcare provider right away if you develop pain, burning, stinging, itching, swelling, or redness of your skin that lasts 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.

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 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 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 on the 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.
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 it for 1 hour after you apply it.
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.

What are the side effects of Zelsuvmi?

Zelsuvmi may cause serious side effects, including:

Application site reactions, including allergic skin reactions, are common where Zelsuvmi is applied to your skin, but can also be severe. Stop using Zelsuvmi and tell your healthcare provider right away if you develop pain, burning, stinging, itching, swelling, or redness of your skin that lasts for more than 24 hours after treatment. The most common side effects of Zelsuvmi affecting 1% or more people are skin reactions where the gel is applied. Symptoms may include include:

redness (11%)
swelling (3.5%)
blisters (1.5%)
pain, burning or stinging (18.7%)
breakdown of the outer layer of the skin (erosion) (1.6%)
lightening or darkening of the skin (1.5%)
itching (5.7%)
irritation (1.2%)
peeling or flaking (5%)
infection (1.1%)
itchy, dry skin rash (4.9%)

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.

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 the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

See the prescribing information for a full list of interactions.

Storage

Before dispensing, Zelsuvmi should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F) until dispensed to the patient. Do not freeze.

After dispensing, store Zelsuvmi 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 open flame.

Ingredients

Tube A

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

Tube B

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