Zelsuvmi
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Amir Ghabousian
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Molluscum contagiosum
Dosing
- Zelsuvmi comes in a carton with Tube A (berdazimer gel), Tube B (hydrogel), and a dosing guide.
- Dispense an equal amount of gel (0.5 mL each) from Tube A and Tube B.
- Combine the gels on the dosing guide.
- Apply the mixed gel as a thin layer to each lesion, once daily, for a maximum of 12 weeks.
- Allow the gel to dry on the skin for at least 10 minutes.
- Avoid spreading the gel to unaffected skin.
- Refrain from exposing the treated area to water for at least one hour post-application.
- Zelsuvmi should not be used in the eyes, mouth, or vagina.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Zelsuvmi in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Zelsuvmi in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Molluscum contagiosum
Dosing
- Zelsuvmi comes in a carton with Tube A (berdazimer gel), Tube B (hydrogel), and a dosing guide.
- Dispense an equal amount of gel (0.5 mL each) from Tube A and Tube B.
- Combine the gels on the dosing guide.
- Apply the mixed gel as a thin layer to each lesion, once daily, for a maximum of 12 weeks.
- Allow the gel to dry on the skin for at least 10 minutes.
- Avoid spreading the gel to unaffected skin.
- Refrain from exposing the treated area to water for at least one hour post-application.
- Zelsuvmi should not be used in the eyes, mouth, or vagina.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Zelsuvmi in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Zelsuvmi in pediatric patients.
Contraindications
- There are no reported contraindications for Zelsuvmi.
Warnings
- Application site reactions, including allergic contact dermatitis, may occur.
- Discontinue use and initiate appropriate therapy if reactions persist for more than 24 hours.
Adverse Reactions
Clinical Trials Experience
- The following local adverse reactions have been reported in connection with the use of Zelsuvmi: application site pain (burning or stinging) in 18.7% of subjects; erythema in 11.7% of subjects; pruritus in 5.7% of subjects; exfoliation in 5.0% of subjects; dermatitis in 4.9% of subjects; swelling in 3.5% of subjects; erosion in 1.6% of subjects; discoloration and vesicles in 1.5% of subjects; irritation in 1.2% of subjects; and infection in 1.1% of subjects.
Postmarketing Experience
There is limited information regarding Mupirocin Postmarketing Experience in the drug label.
Drug Interactions
The effect of the concurrent application of Zelsuvmi and other drug products has not been studied.
Use in Specific Populations
Pregnancy
- Currently, there is no clinical data on the use of Zelsuvmi during pregnancy to assess its potential risk for birth defects, miscarriage, or other adverse effects on maternal or fetal health. However, animal studies in pregnant rats and rabbits have demonstrated an increased incidence of fetal malformations when berdazimer was administered orally at doses that caused significant maternal toxicity.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zelsuvmi in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Zelsuvmi during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Zelsuvmi in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Zelsuvmi in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Zelsuvmi in geriatric settings.
Gender
There is no FDA guidance on the use of Zelsuvmi with respect to specific gender populations.
Race
There is no FDA guidance on the use of Zelsuvmi with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Zelsuvmi in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Zelsuvmi in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Zelsuvmi in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Zelsuvmi in patients who are immunocompromised.
Administration and Monitoring
Administration
Administration
- Apply a small amount of Zelsuvmi as a thin, even layer to each molluscum contagiosum lesion once daily.
- If no clinical improvement occurs after 12 weeks, reassess treatment.
Monitoring
Monitoring
- Limited information is available on the monitoring of Zelsuvmi in the drug label.
IV Compatibility
Not applicable. Zelsuvmi is for topical use only.
Overdosage
- No specific information is available on overdose of Zelsuvmi. In case of accidental ingestion, contact poison control or seek medical attention immediately.
Pharmacology
There is limited information regarding Zelsuvmi Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Zelsuvmi Mechanism of Action in the drug label.
Structure
There is limited information regarding Zelsuvmi Structure in the drug label.
Pharmacodynamics
There is limited information regarding Zelsuvmi Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Zelsuvmi Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Zelsuvmi Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Zelsuvmi Clinical Studies in the drug label.
How Supplied
There is limited information regarding Zelsuvmi How Supplied in the drug label.
Storage
There is limited information regarding Zelsuvmi Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Zelsuvmi Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Zelsuvmi interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Zelsuvmi Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Zelsuvmi Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.