YCANTH- cantharidin solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Cantharidin (UNII: IGL471WQ8P) (cantharidin - UNII:IGL471WQ8P)

Disponível em:

Verrica Pharmaceuticals Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. None 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 [see Clinical Pharmacology (12.3)]. 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. Risk Summary Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. There are no data on the presence of cantharidin in either human or animal milk, or the effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the child to the drug due to the low systemic absorption of YCANTH following topical administration [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YCANTH topical solution and any potential adverse effects on the breastfeeding child from YCANTH topical solution or from the underlying maternal condition. 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 [see Clinical Studies (14) ]. The safety and efficacy in pediatric patients below the age of 2 years have not been established. Risk Summary YCANTH has not been studied in geriatric patients.

Resumo do produto:

YCANTH topical solution is supplied in a sealed glass ampule contained within a single-use applicator and enclosed in a protective paperboard sleeve. Each ampule of YCANTH contains approximately 0.45 mL of 0.7% cantharidin solution. Each mL of YCANTH contains 7 mg cantharidin (0.7%). A YCANTH Break Tool is co-packaged as 2 units per each carton of applicators. A listing of the available carton packages is provided in Table 3. Individual YCANTH Break Tools are available separately (Part Reference Number 71349-000-01). To request additional YCANTH Break Tools, contact Verrica Pharmaceuticals at 1-800-843-7477. Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature], protect from light.

Status de autorização:

New Drug Application

Características técnicas

YCANTH- CANTHARIDIN SOLUTION
VERRICA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YCANTH SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YCANTH.
YCANTH™ (CANTHARIDIN) TOPICAL SOLUTION
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
YCANTH is indicated for the topical treatment of molluscum contagiosum
in adult and pediatric patients 2
years of age and older. (1)
DOSAGE AND ADMINISTRATION
All healthcare professionals should receive instruction and training
prior to preparation and
administration of YCANTH. (2.1)
For topical use only. Not for oral, mucosal, or ophthalmic use. (2.1)
Apply a single application directly to each lesion every 3 weeks as
needed. (2.2)
Do not use more than two applicators during a single treatment
session. (2.2)
Remove with soap and water 24 hours after treatment. (2.2)
For additional instructions on preparation and administration of
YCANTH, see Full Prescribing
Information. (2.1, 2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Topical solution: 0.7% cantharidin. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
_Toxicities Associated with Inappropriate Administration:_ Life
threatening or fatal toxicities can occur if
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
YCANTH gets in eyes, flush eyes with
water for at least 15 minutes. (5.1)
_Local Skin Reactions_: Reactions at the application site have
included vesiculation, pruritus, pain,
discoloration, and erythema. Avoid application near eyes and mucosal
tissue, and to healthy skin. If
YCANTH contacts any unintended surface, or healthy skin, immediately
remove. If severe local skin
reactions occur, remove prior to 24 hours after treatment. (5.2)
_Flammability_: YCANTH is flammable, even after drying. Avoid fire,
flame or smoking near lesion(s)
during treatment and after application until removed. (5.3)
ADVERSE REACTIO