Ycanth Drug Information

YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

Important Administration Instructions

All healthcare professionals should receive instruction and training prior to preparation and administration of YCANTH. YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use.

Avoid contact with the treatment area, including oral contact, after YCANTH treatment. Do not apply YCANTH near the eyes. If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze.

Avoid other topical products on treated areas until 24 hours after YCANTH treatment or until washing. Avoid fire, flame or smoking near lesion(s) during treatment.

Dosage and Administration Overview Regarding

• YCANTH dosage and administration: Use nitrile or vinyl gloves and eye protection during preparation and administration. Apply topically as a single application to cover each lesion. Use no more than two YCANTH applicators during a single treatment session. Remove with soap and water 24 hours after treatment. Administer YCANTH every 3 weeks as needed. Do not cover any treated lesions with bandages.
• Regarding use of the YCANTH applicator and break tool: Do not reuse the applicator. The applicator is for a single treatment session only. Do not attempt to use a clogged applicator. Do not cut or modify the applicator in any way; doing so could reduce dispensing control. Do not remove the applicator cap prior to breaking the glass ampule. If any damage or leaks are observed on the applicator, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. The YCANTH Break Tool should be managed as solid waste and placed in plastic recycling containers or the general trash.

Dosage and Administration Instructions Instructions for preparing the YCANTH Applicator and administering the YCANTH Solution are presented below. YCANTH includes the following components: YCANTH Break Tool Maintenance Wipe the surfaces of the YCANTH Break Tool with 70% isopropyl alcohol following each use. Inspect the YCANTH Break Tool for damage (e.g., cracks in plastic, missing or broken breaking posts) and function (e.g., hinge) prior to each use.

If needed, contact Verrica Pharmaceuticals Inc. at 1-973-298-1390 to request additional YCANTH Break Tools. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

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. Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments. Adverse reactions were primarily local skin reactions at the application site.

Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during both trials. Table 1. Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population) There were no serious adverse reactions reported in the two controlled trials.

The discontinuation rate due to an adverse reaction was 2.3% among subjects treated with YCANTH and 0.5% among subjects treated with vehicle.

Pregnancy Risk Summary There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with cantharidin. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug.

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 respectively.

Pediatric Use Risk Summary The safety and effectiveness of YCANTH for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. The use of YCANTH in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established. The safety and efficacy in pediatric patients below the age of 2 years have not been established.

Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. In the event that YCANTH topical solution is ingested, patients should seek medical attention immediately and contact a Poison Control Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.