b'Brief Summary YCANTH (cantharidin) topical solution, 0.7%YCANTHVehicle n=311n=216 Brief Summary of full Prescribing Information, See full Prescribing PreferredMildMode SevereMildMode Severe Information. Rx Only.Term Nameraterate INDICATIONS AND USAGEApplication site60%32%4%27%2%0% YCANTH is indicated for the topical treatment of molluscum contagiosum invesicles adult and pediatric patients 2 years of age and older. DOSAGE AND ADMINISTRATIONApplication site41%20%2%16%1%0% YCANTH is for topical use only and not for oral, mucosal, or ophthalmic use. pain and pain Important Administration Instructions and Dosage and AdministrationApplication site47%8%1%30%7%0% Overview:pruritus andSee WARNINGS AND PRECAUTIONS and Preparations andpruritus Administration sections. Use nitrile or vinyl gloves and eye protection during preparation andApplication site39%9%0%20%1%0% administration.scab and scabDO NOT apply YCANTH near the eyes.DO NOT reuse the YCANTH applicator. The applicator is for a single Application site24%21%1%20%7%0% treatment session only.erythema andDO NOT attempt to use a clogged applicator. erythemaDO NOT cut or modify the applicator in any way; doing so could reduce dispensing control. Application site28%4%1%12%1%0%DO NOT remove the applicator cap prior to breaking the glass ampule. discolorationIf any damage or leaks are observed on the applicator, applicators should bediscarded in a sharps container and handled in accordance with acceptedApplication site19%2%0%14%1%0% medical practice and applicable law. The YCANTH Break Tool should be dryness managed as solid waste and placed in plastic recycling containers or the general trash.Application site7%3%0%3%1%0% edema CONTRAINDICATIONS None. Application site6%1%0%1%0%0% erosion WARNINGS AND PRECAUTIONS Toxicities Associated with Inappropriate Administration: YCANTH is forContact 0%1%0%0%0%0% topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Lifedermatitis threatening or fatal toxicities can occur if YCANTH is administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTHDRUG INTERACTIONS gets in eyes, flush eyes with water for at least 15 minutes.No studies evaluating the drug interaction potential of cantharidin have been Local Skin Reactions: Reactions at the application site may occur, includingconducted. vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin. If YCANTH contacts anyUSE IN SPECIAL POPULATIONS unintended surface, or healthy skin, immediately remove. If severe Pregnancy: There are no available data with use of YCANTH in pregnant local skin reactions occur, remove prior to the recommended 24 hours afterwomen to evaluate for a drug-associated risk of major birth defects,treatment.miscarriage or adverse maternal or fetal outcomes. Given that systemicFlammability: YCANTH is flammable, even after drying. Avoid fire, flame orexposure to cantharidin following topical administration is low, maternal use is smoking near lesion(s) during treatment and after application until removed. not expected to result in fetal exposure to the drug. ADVERSE REACTIONSLactation: Avoid application of YCANTH topical solution to areas withThe following adverse reactions are described in the Warnings and increased risk for potential ingestion by or ocular exposure to the breastfeeding Precautions section: Local Skin Reactions.child.Pediatric Use: The safety and effectiveness of YCANTH for the treatment of Clinical Trials Experience: Because clinical trials are conducted under widelymolluscum contagiosum have been established in pediatric patients aged 2 years varying conditions, adverse reaction rates observed in the clinical trials of a drugand older. The use of YCANTH in pediatric patients is supported by results cannot be directly compared to rates in the clinical trials of another drug andfrom adequate and well-controlled trials in patients 2 years of age and older; may not reflect the rates observed in practice.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. YCANTH was studied in two randomized, double-blind, placebo-controlledGeriatric Use: YCANTH has not been studied in geriatric patients. phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803)(n = 266, and n = 262, respectively) in subjects with molluscum contagiosum.OVERDOSAGE Most patients received a single 24-hour dermal administration of YCANTH orOral ingestion of cantharidin has resulted in renal failure, blistering andvehicle for each lesion every 3 weeks for up to 4 treatments. YCANTH Solutionsevere damage to the gastrointestinal tract, coagulopathy, seizures, andor vehicle were removed prior to the 24-hour timepoint in 109/311 (35%)flaccid paralysis.subjects treated with YCANTH Solution and 46/216 (21%) subjects treated withPATIENT COUNSELING INFORMATION vehicle due to treatment-emergent adverse events.Advise the patient and/or caregivers to read the FDA-approved patient Table 1 presents the percentage of subjects with selected adverse reactionslabeling (Patient Information). (incidence1%) by the most severe grade reported during Trial 1 and Trial 2. Adverse reactions were primarily local skin reactions at the application site.Manufactured by: Local skin reactions at the application site were observed in 97% of subjectsPharmaceutical Packaging Solutions treated with YCANTH during both trials. 341 JD Yarnell Industrial Pkwy, Table 1. Percentage of Subjects with Selected Adverse Reactions Clinton, TN 37716 (Incidence 1%) by Severity in Trial 1 and Trial 2 (Safety Population) For: Verrica Pharmaceuticals Inc. 44 West Gay Street, Suite 400 West Chester, PA 19380 YCANTH and VERRICA are registered trademarks of Verrica Pharmaceuticals Inc. Copyright2024 Verrica Pharmaceuticals Inc. All rights reserved.'