Berdazimer

FDA Drug Information • Also known as: Zelsuvmi

Brand Names: Zelsuvmi
Dosage Form: KIT
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 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 purified water. Structural Formula

What Is Berdazimer Used For?

1 INDICATIONS AND USAGE ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION 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, bathing, or washing for 1 hour after application of ZELSUVMI. ZELSUVMI is for topical use only and not for ophthalmic, oral, or intravaginal use.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS 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 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 ZELSUVMI N=916 Vehicle Gel N=680 Adverse Reaction 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.

Contraindications

4 CONTRAINDICATIONS None. None.

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary 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. Data 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...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZELSUVMI (berdazimer) topical gel, 10.3% is supplied in a carton (NDC 83787-103-31) containing: Tube A (14 g) with blue label containing berdazimer sodium in an opaque white to off-white gel (NDC 83787-113-14) Tube B (17 g) with yellow label containing translucent to opaque white to off-white gel (UPC 83787-0000-17) Dosing Guide Storage and Handling Prior to Dispensing : Store ZELSUVMI in a refrigerator between 2°C and 8°C (36°F and 46°F) until dispensed to the patient. Write the “Discard after” date in the space provided on the carton. After Dispensing : Store ZELSUVMI at room temperature, between 20°C to 25°C (68°F and 77°F) in a dry location. Product contains alcohol and should be kept away from open flame. Do not freeze. Discard 60 days after removal from refrigeration.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.