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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[{[3Â(methylamino)propyl]silasesquioxane}-co-{[3-(1-methyl-2-nitroso2-oxidohydrazin-1Âyl)propyl]silasesquioxane}-co-silicate (1:3:6 x)], partially hydrolyzed (Si : OH ~ 10 : 5), and the following structural and empirical formula:
Structural Formula:
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* 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:
ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.
Topical gel: 10.3% berdazimer in an opaque white to off-white gel. ZELSUVMI is supplied as two tubes. Tube A with a blue label contains 14 grams of berdazimer gel and Tube B with a yellow label contains 17 grams of hydrogel.
ZELSUVMI (berdazimer) topical gel, 10.3% is supplied in a carton (NDC 71403-103-31) containing:
Tube A (14 g) with blue label containing berdazimer sodium in an opaque white to off-white gel (NDC 71403-113-14)
Tube B (17 g) with yellow label containing translucent to opaque white to off-white gel (UPC 71403-0000-17)
Dosing Guide
Manufactured for: EPIH SPV, LLC Wilmington, Delaware 19801. Revised: Jan 2024
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]. 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 more frequently than vehicle-treated subjects are listed in Table 1.
Table 1: Adverse Reactions Reported by ≥ 1% of Subjects with MC Treated with ZELSUVMI (and Greater than Vehicle) Day 1 through Week 12 in Trials 1, 2, and 3
| Adverse Reaction | ZELSUVMI N=916 |
Vehicle Gel N=680 |
||||
| Mild n (%) |
Moderate n (%) |
Severe n (%) |
Mild n (%) |
Moderate n (%) |
Severe n (%) |
|
| Subjects with any TEAE* | 220 (24.0) | 192 (21.0) | 16 (1.7) | 118 (17.4) | 47 (6.9) | 4 (0.6) |
| Application Site Pain† | 113 (12.3) | 56 (6.1) | 2 (0.2) | 30 (4.4) | 3 (0.4) | 0 |
| Application Site Erythema | 48 (5.2) | 55 (6.0) | 4 (0.4) | 7 (1.0) | 2 (0.3) | 0 |
| Application Site Pruritus | 36 (3.9) | 15 (1.6) | 1 (0.1) | 5 (0.7) | 2 (0.3) | 0 |
| Application Site Exfoliation | 18 (2.0) | 26 (2.8) | 2 (0.2) | 0 | 0 | 0 |
| Application Site Dermatitis | 16 (1.7) | 26 (2.8) | 3 (0.3) | 3 (0.4) | 2 (0.3) | 0 |
| Application Site Swelling | 17 (1.9) | 14 (1.5) | 1 (0.1) | 3 (0.4) | 1 (0.1) | 0 |
| Pyrexia | 14 (1.5) | 6 (0.7) | 0 | 6 (0.9) | 1 (0.1) | 0 |
| Application Site Erosion | 7 (0.8) | 5 (0.5) | 3 (0.3) | 1 (0.1) | 0 | 0 |
| Application Site Discoloration | 13 (1.4) | 1 (0.1) | 0 | 1 (0.1) | 0 | 0 |
| Application Site Vesicles | 5 (0.5) | 9 (1.0) | 0 | 0 | 1 (0.1) | 0 |
| Vomiting | 5 (0.5) | 7 (0.8) | 0 | 1 (0.1) | 0 | 0 |
| Application Site Irritation | 7 (0.8) | 4 (0.4) | 0 | 0 | 0 | 0 |
| Upper Respiratory Tract Infection | 6 (0.7) | 5 (0.5) | 0 | 4 (0.7) | 1 (0.1) | 0 |
| Application Site Infection | 4 (0.4) | 4 (0.4) | 2 (0.2) | 2 (0.3) | 1 (0.1) | 0 |
| * TEAE – treatment emergent adverse events † Application site pain also includes application site burning and stinging. |
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No Information provided
Included as part of the PRECAUTIONS section.
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.
Advise the patient or caregiver to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Advise patients to discontinue ZELSUVMI and seek medical attention immediately if signs or symptoms of application site reactions lasting more than 24 hours occur [see WARNINGS AND PRECAUTIONS].
Advise patients that ZELSUVMI is for external use only and is not for ophthalmic, oral, or intravaginal use [see DOSAGE AND ADMINISTRATION].
Inform patients that ZELSUVMI is supplied with two gel components that must be mixed together immediately before application. Instruct patients not to premix or store mixed ZELSUVMI [see DOSAGE AND ADMINISTRATION].
Advise patients to wash hands after applying ZELSUVMI (unless hands are being treated) and avoid transfer of the product to other areas of the skin, including the eye [see DOSAGE AND ADMINISTRATION].
Instruct patients to carefully follow the instructions for preparing and administering ZELSUVMI in the ZELSUVMI FDA-approved patient labeling [see Instructions For Use].
The carcinogenic potential of berdazimer gel was assessed in a 2-year dermal mouse carcinogenicity study. There were no drug-related tumor findings associated with daily topical administration of berdazimer gel to mice at doses up to 4% berdazimer gel.
Berdazimer was mutagenic in a bacterial mutagenicity assay (Ames assay) but was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes or in an in vivo micronucleus assay in rats.
There were no berdazimer related effects on male or female fertility and early embryonic parameters in rats at oral doses up to 189 mg/kg/day.
There are no available data on ZELSUVMI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of berdazimer to pregnant rats and rabbits increased malformations in the presence of severe maternal toxicity (see Data). The clinical relevance of this finding is unknown given the bioavailability of berdazimer following oral administration is significantly higher than topical application.
The available data do not allow the calculation of relevant comparisons between the systemic exposure of berdazimer observed in animal studies and the systemic exposure that would be expected in humans after topical use of ZELSUVMI.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Animal Data
Systemic embryo-fetal development studies were conducted in rats and rabbits. In an embryo-fetal development study in rats, oral dose levels of 28, 95, or 189 mg/kg/day berdazimer were administered during the period of organogenesis. Maternal mortality and elevated methemoglobin levels were noted in dams receiving doses of 95 and 189 mg/kg/day. The maternal no observable adverse effect level (NOAEL) was 28 mg /kg/day. Fetal skeletal malformations (changes in the lumbar and thoracic centra or arches, missing thoracic arches and centra, additional bone in the thoracic arches, missing lumbar centra and arches, and fused ribs) and visceral malformations (cleft palate) and decreased fetal weights were observed in litters from dams receiving 189 mg/kg/day. The fetal NOAEL was 95 mg/kg/day.
In an embryo-fetal development study in rabbits, oral dose levels of 47, 142, or 284 mg/kg/day berdazimer were administered during the period of organogenesis. Maternal mortality, aborted fetuses, adverse clinical observations, and elevated methemoglobin levels were noted in pregnant rabbits receiving doses of 142 and 284 mg/kg/day. The maternal NOAEL was 47 mg/kg/day. Decreased fetal weights were noted from pregnant rabbits receiving 284 mg/kg/day. The fetal NOAEL was 142 mg/kg/day.
There are no data on the presence of berdazimer or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZELSUVMI and any potential adverse effects on the breastfed infant from ZELSUVMI or from the underlying maternal condition.
The safety and effectiveness of ZELSUVMI for the topical treatment of MC have been established in pediatric patients 1 year of age and older. Use of ZELSUVMI for this indication is supported by data from three randomized, vehicle-controlled, double-blind trials involving 1596 subjects of which 1575 were pediatric subjects with MC (904 were exposed to ZELSUVMI; 29 subjects were less than 2 years of age, including one subject less than 1 year of age, and 875 were 2 to 17 years of age) [see Clinical Studies].
The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.
Of the total number of ZELSUVMI-treated subjects in clinical studies for MC, none were 65 to 74 years of age, and one was 75 years of age and older [see Clinical Studies]. Clinical studies of ZELSUVMI did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
No Information provided
None.
ZELSUVMI is a nitric oxide releasing agent. The mechanism of action for the treatment of molluscum contagiosum is unknown.
The pharmacodynamics of ZELSUVMI are unknown.
Plasma hydrolyzed MAP3 (hMAP3), a structural marker for berdazimer, and nitrate levels were evaluated in n=34 subjects 2 to 12 years of age with MC. Subjects applied ZELSUVMI once-daily for two weeks to a total treatment area of 484 cm² (mean lesion count=34), applying a mean dose of approximately 3 mL/day. No subjects had quantifiable plasma hMAP3 concentrations on day 1; two subjects had quantifiable concentrations on day 15. Mean plasma nitrate levels were similar on days 1 and 15 and remained relatively flat during the PK sampling period (baseline through 1, 3, and 6 hours post-application).
There were no apparent differences in methemoglobin levels throughout the study.
The efficacy of ZELSUVMI was evaluated in 3 multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials in subjects with MC (Trials 1, 2, and 3; NCT04535531, NCT03927703, and NCT03927716, respectively). Trial 1 enrolled 891 subjects, Trial 2 enrolled 355 subjects, and Trial 3 enrolled 352 subjects. Subjects were randomized 1:1 in Trial 1, and 2:1 in Trials 2 and 3 to receive ZELSUVMI or vehicle applied to MC lesions once daily for up to 12 weeks.
In the three 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. Subjects had 3-70 baseline MC lesions. At baseline, the average MC lesion count was 20.2.
The primary efficacy endpoint was the proportion of subjects achieving complete clearance at Week 12. Complete clearance was defined as the subject having a total MC lesion count of 0 at assessment. The key secondary efficacy endpoint was complete clearance rate at Week 8.
Efficacy was demonstrated in Trials 1 and 2. The results are summarized in Table 2.
Table 2: Complete Clearance Rate at Week 12 and Week 8 in Subjects with MC in Trials 1 and 2
| Trial 1 | Trial 2 | |||
| ZELSUVMI (N=444) |
Vehicle (N=447) |
ZELSUVMI (N=237) |
Vehicle (N=118) |
|
| Complete Clearance Rate at Week 12 (Primary Endpoint) | 32.4% | 19.7% | 30.0% | 20.3% |
| Treatment Difference (95% Confidence Interval) | 12.8% (7.1%, 18.6%) |
9.2% (-0.04%, 18.4%) |
||
| Complete Clearance Rate at Week 8 (Secondary Endpoint) | 19.6% | 11.6% | 13.9% | 5.9% |
| Treatment Difference (95% Confidence Interval) | 7.5% (3.0%, 12.0%) | 7.8% (1.8%, 13.8%) | ||
In Trial 3, the complete clearance rates at Week 12 were 26% versus 22% for ZELSUVMI and vehicle, respectively, with 95% confidence interval (-5%, 14%).
ZELSUVMI™
(zel-SOOV-mee)
(berdazimer) topical gel
Important information: ZELSUVMI is for use on the skin (for topical use) only. Do not use ZELSUVMI near or in your eyes, mouth, or vagina.
What is ZELSUVMI?
ZELSUVMI is a prescription medicine used on the skin (topical) to treat molluscum contagiosum (MC) in adults and children 1 year of age and older. It is not known if ZELSUVMI is safe and effective in children under 1 year of age.
Before using ZELSUVMI, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ZELSUVMI?
What are the possible side effects of ZELSUVMI?
ZELSUVMI may cause serious side effects, including:
The most common side effects of ZELSUVMI include:
These are not all of the possible side effects of ZELSUVMI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZELSUVMI?
Keep ZELSUVMI and all medicines out of the reach of children.
General information about the safe and effective use of ZELSUVMI.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZELSUVMI for a condition for which it was not prescribed. Do not give ZELSUVMI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZELSUVMI that is written for health professionals.
What are the ingredients in ZELSUVMI?
Tube A
Active ingredient: berdazimer sodium
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
INSTRUCTIONS FOR USE
ZELSUVMI™
(zel-SOOV-mee)
(berdazimer) topical gel, 10.3%
This Instructions for Use contains information on how to prepare and apply ZELSUVMI. Read this Instructions for Use before you start using ZELSUVMI and each time you get a new prescription. Apply ZELSUVMI exactly as your healthcare provider tells you to. Ask your healthcare provider if you have any questions.
Box Contents (Figure A)
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Important Information You Need to Know Before Applying ZELSUVMI:
Preparing to Apply ZELSUVMI
Turn to the back page for more instructions.
Instructions begin on the other side.
Applying ZELSUVMI
Step 1. Wash Hands
Always wash and dry hands before applying gel.
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Step 2. Dispense Gel
Place Dosing Guide on a flat surface.
Remove cap from Tube A. Hold Tube A near blue Tube A dosing lane. Squeeze gel onto blue lane to cover entire area of the lane. The gel is white on the Dosing Guide. Screw cap back onto Tube A.
Remove cap from Tube B. Hold Tube B near yellow Tube B dosing lane. Squeeze gel onto yellow lane to cover entire area of the lane. The gel is clear to almost clear on the Dosing Guide. Screw cap back onto Tube B.
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Step 3. Mix Gels
Use a fingertip to combine the 2 gels from the blue and yellow lanes. Mix the gels in the center of the Dosing Guide using a circular motion. It is important that the 2 gels get mixed well. Mix the 2 gels together while slowly counting to 20. You may see clumps during mixing and this is normal. Apply the mixed gel right away to the bumps.
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Step 4. Apply Mixed Gel
Apply an even thin layer of mixed gel to each bump right away.
Make sure to cover bumps that are new, hard to reach, or out of sight.
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If you run out of mixed gel before you have treated all the bumps, wipe off your Dosing Guide with a dry tissue. Follow steps 2, 3, and 4 to apply the mixed gel to the remaining untreated bumps.
After all bumps have been treated:
Step 5. Clean Dosing Guide
Use water and mild soap to remove remaining gel from Dosing Guide. Dry Dosing Guide.
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Step 6. Storing ZELSUVMI
Put dry Dosing Guide and this Instructions for Use back in box. Secure caps on tubes and place back in box.
Store ZELSUVMI at room temperature between 68°F to 77°F (20°C to 25°C) in a dry location. Product contains alcohol and should be kept away from open flame. Do not freeze. Throw away if not used within 60 days after receiving ZELSUVMI.
Step 7. Wash Hands
Always wash hands after you place the contents back in the box unless your hands were treated.
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Disposing of ZELSUVMI
Throw away (dispose of) tubes in household trash when empty or when treatment is stopped.
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This Instructions for Use has been approved by the U.S. Food and Drug Administration.
