Ycanth Drug Information

Generic name: CANTHARIDIN

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Uses of Ycanth

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

Dosage & Administration of Ycanth

Outer Protective Tube
The YCANTH Applicator
The YCANTH Break Tool
Step 1. Put on Personal Protective Equipment (PPE)
  • Put on gloves and eye protection.
Step 2. Remove the YCANTH Applicator from Outer Protective Tube
  • Use pull ring to remove purple end cap out of white outer protective tube.
  • DO NOT remove the applicator cap.
  • Slide the YCANTH Applicator out of the outer protective tube.
Step 3. Remove the Paperboard Sleeve
  • Completely remove the white paperboard sleeve so that the glass ampule is visible.
  • DO NOT remove the applicator cap prior to breaking the glass ampule.
Step 4. Inspect for Damage
  • Inspect the YCANTH Applicator for the following types of damage:
Broken glass ampule Cut or cracked applicator tube
  • If any damage is observed, dispose of the YCANTH applicators in a sharps container and handle in accordance with accepted medical practice and applicable law.
Step 5. Break Ampule using the YCANTH Break Tool
  • Set the YCANTH Break Tool on a horizontal surface.
  • Ensure the applicator cap is in place.
  • Place the YCANTH Applicator in the YCANTH Break Tool with the cap pointing toward the hinge.
  • Press down firmly on the YCANTH Break Tool until a snap is heard.
  • Open the YCANTH Break Tool and remove the YCANTH Applicator.
  • If any leaks are observed, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law.
Step 6. Tap YCANTH Applicator to move YCANTH Solution
  • Gently tap the capped end of the YCANTH Applicator on a horizontal surface for approximately 10 seconds or until the YCANTH Solution has collected at the bottom of the applicator tube.
Step 7. Test the YCANTH Applicator
  • Remove the applicator cap.
  • Gently squeeze the applicator tube to apply a droplet to a paper towel or gauze to confirm the YCANTH Applicator is working properly.
Step 8. Apply the YCANTH Solution
  • Apply a small droplet of the YCANTH Solution onto a molluscum lesion.
  • Use the applicator tip to spread the solution to cover the entire lesion.
  • Repeat the application until all lesions have been treated.
    • If YCANTH Solution contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze.
    • DO NOT attempt to use a clogged YCANTH Applicator.
Step 9. Allow YCANTH Solution to Dry
  • Allow the YCANTH Solution to completely dry (up to 5 minutes) before contacting healthy skin to avoid transference.
  • DO NOT cover any treated lesions with bandages.
Step 10. Dispose of the YCANTH Applicator
  • Applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law.
  • DO NOT reuse the YCANTH Applicator.

Side Effects of Ycanth

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. YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803) (n = 266, and n = 262, respectively) in subjects with molluscum contagiosum. Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments.

YCANTH Solution or vehicle were removed prior to the 24-hour timepoint in 109/311 (35%) subjects treated with YCANTH Solution and 46/216 (21%) subjects treated with vehicle due to treatment-emergent adverse events. Table 1 presents the percentage of subjects with selected adverse reactions (incidence ≥ 1%) by the most severe grade reported during Trial 1 and Trial 2. 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) YCANTH N=311 Vehicle N=216 Preferred Term Name Mild Moderate Severe Mild Moderate Severe Application site vesicles 60% 32% 4% 27% 2% 0% Application site pain and pain 41% 20% 2% 16% 1% 0% Application site pruritus and pruritus 47% 8% 1% 30% 7% 0% Application site scab and scab 39% 9% 0% 20% 1% 0% Application site erythema and erythema 24% 21% <1% 20% 7% 0% Application site discoloration 28% 4% <1% 12% 1% 0% Application site dryness 19% 2% 0% 14% 1% 0% Application site edema 7% 3% 0% 3% 1% 0% Application site erosion 6% 1% 0% 1% 0% 0% Contact dermatitis 0% 1% 0% 0% 0% 0% 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.

Warnings & Cautions for Ycanth

Toxicities Associated with Inappropriate

Administration YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally.

Adverse reactions to oral ingestion of cantharidin have included renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. Advise patients and/or caregivers to avoid oral contact and to avoid touching lesions after YCANTH treatment and to seek medical attention immediately if YCANTH is accidently ingested. Ocular toxicity can occur if YCANTH comes in contact with the eyes.

Adverse reactions from contact of YCANTH with the eyes can include corneal necrosis, ocular perforation, and deep ocular injuries. Do not apply YCANTH near or to the eyes. If YCANTH comes in contact with the eyes, flush eyes with water for at least 15 minutes and seek medical attention immediately.

Local Skin Reactions

YCANTH is a vesicant. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. Local skin reactions included vesiculation, pruritus, pain, discoloration, and erythema . Avoid application near the eyes and mucosal tissues, and to adjacent healthy skin.

If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze. Avoid other topical products (e.g. creams, lotions, or sunscreen) on treated areas until 24 hours after YCANTH treatment or until washing. Application of other topical products could spread YCANTH and cause blistering or other adverse reactions to healthy skin.

If severe blistering, severe pain or other severe adverse reactions occur, remove YCANTH prior to the recommended 24 hours after administration by washing with soap and water.

Flammability

YCANTH is a flammable liquid, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed.

Pregnancy Safety for Ycanth

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 2% to 4% and 15% to 20%, respectively.

Pediatric Use of Ycanth

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.

Overdosage Information for Ycanth

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.

Clinical Studies of Ycanth

In two double-blind, randomized, placebo-controlled trials (Trial 1 and Trial 2 ), 528 subjects ages 2 years and older with molluscum contagiosum were randomized by household to treatment with either YCANTH or vehicle. Subjects ranged from 2 to 60 years of age, with a median age of 6. 51% of subjects were male and 91% were Caucasian. The baseline lesion count among subjects ranged from 1 to 184, with a mean of 23 and 19 lesions among subjects in Trial 1 and Trial 2, respectively.

Subjects' lesions were treated with either YCANTH or vehicle at intervals of approximately 21 days until complete clearance of the lesion or for a maximum of 4 applications (on Days 1, 21, 42, and 63). Study drug solution was applied and left on the lesions for approximately 24 hours before the lesions were washed with soap and water. A healthcare professional who was blinded to the treatment group counted the number of lesions at each visit. The primary efficacy endpoint was the proportion of patients achieving complete clearance of all treated molluscum contagiosum lesions by Day 84. The secondary efficacy endpoints were the proportions of patients achieving complete clearance of all treated molluscum contagiosum lesions at Day 63, Day 42, and Day 21. Table 2 presents the efficacy results for Trial 1 and Trial 2. Table 2. Percentage of Subjects Exhibiting Complete Clearance of Treatable Molluscum Contagiosum Lesions in Trial 1 and Trial 2 (Intent-to-Treat Population) Trial 1 Trial 2 YCANTH N = 160 Vehicle N = 106 Treatment Difference (95% CI) Treatment difference and 95% CI based on Generalized Estimating Equations (GEE) model for logistic regression with an exchangeable working correlation structure, a factor for treatment, and repeated measurements allowed for a household.

Subjects with missing data are imputed as non-responders. YCANTH N = 150 Vehicle N = 112 Treatment Difference (95% CI) CI = confidence interval. Day 84 46% 18% 29% (19%, 38%) 54% 13% 40% (30%, 51%) Day 63 32% 17% 15% (4%, 25%) 28% 5% 23% (15%, 32%) Day 42 21% 9% 10% (2%, 19%) 13% 4% 9% (3%, 16%) Day 21 11% 4% 8% (2%, 14%) 5% 2% 3% (-1%, 8%)

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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