Dosing & Uses
Dosage Forms & Strengths
topical cream
- 1%
Acne Vulgaris
Indicated for acne vulgaris in patients aged ≥12 years
Apply thin layer topically to affected area BID
Dosage Forms & Strengths
topical cream
- 1%
Acne Vulgaris
Indicated for acne vulgaris in patients aged ≥12 years
<12 years: Safety and efficacy not established
≥12 years: Apply thin layer topically to affected area BID
Adverse Effects
>10%
Adverse effects listed below for the drug were similar to those for the vehicle cream in clinical trials
Erythema/redness (12.2%)
Scaling/dryness (10.5%)
1-10%
Adverse effects listed below for the drug were similar to those for the vehicle cream in clinical trials
Pruritus (7.7%)
Stinging/burning (4.2%)
Edema (3.6%)
Striae rubrae (2.5%)
Skin atrophy (1.6%)
Telangiectasia (1.2%)
Frequency Not Defined
Metabolism: Hyperkalemia
Reproductive: Polycystic ovaries, amenorrhea
Warnings
Contraindications
None
Cautions
May induce local irritation (eg, erythema, redness, pruritus, scaling, dryness); limit concomitant use with other potentially irritating topical products that have a strong drying effect or have high concentrations of alcohol, astringents, spices, or lime
HPA axis suppression
- Hypothalamic-pituitary-adrenal (HPA) axis suppression observed in clinical trials; may occur during or after treatment
- Conditions that increase systemic absorption include use over large surface areas, prolonged use, and occlusive dressings
- If HPA axis suppression develops, attempt to withdraw the drug
- Pediatric patients may be more susceptible to systemic toxicity
Pregnancy & Lactation
Pregnancy
No data are available on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal studies
- Subcutaneous administration to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose, respectively, increased malformations in rats and postimplantation loss and resorptions in rabbits
Lactation
Data are not available regarding presence of clascoterone or metabolite in human milk, effects on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Exact mechanism of action is unknown; laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles
Absorption
Measured on Day 14 of BID dosing
Peak plasma concentration: 4.5 ng/mL
Average plasma concentration: 1.9 ng/mL
AUC: 37 ng⋅hr/mL
Steady-state achieved on Day 5
Distribution
Protein bound: 84-89%
Metabolism
Plasma concentrations of cortexolone, a possible primary metabolite, were detectable and generally below or near the lower limit of quantitation (0.5 ng/mL)
Elimination
Excretion: Not characterized
Administration
Topical Administration
For topical use only; not for ophthalmic, oral, or vaginal use
Gently cleanse affected area; after skin is dry, apply thin uniform layer of cream to affected area(s) twice per day (morning and evening)
Do not apply to cuts, abrasions, or eczematous or sunburned skin
Avoid concomitant use of other potentially irritating topical products
Avoid accidental transfer of cream into eyes, mouth, or other mucous membranes; if this occurs, rinse thoroughly with water
Storage
Before dispensing: Refrigerate at 36-46ºF (2-8ºC)
After dispensing to patient: Store at room temperature of 68-77ºF (20-25ºC); discard unused product 180 days after dispensing or 1 month after first opening, whichever is sooner
Do not freeze
Images
Formulary
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