There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Clascoterone: Pediatric drug information")
Acne vulgaris: Children ≥12 years and Adolescents: Topical: Apply thin layer to the affected area twice daily, in the morning and the evening.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Reversible hypothalamic-pituitary-adrenal axis suppression (HPA-axis suppression) has been observed with clascoterone therapy.
Mechanism: Dose-related; related to the pharmacologic action (androgen receptor inhibitor).
Onset: Varied; in a pharmacokinetic trial, laboratory evidence of HPA-axis suppression was observed 2 weeks after initiation of therapy and in these subjects returned to normal 4 weeks after therapy discontinuation (Ref).
Risk factors:
• Children and adolescents (may be more susceptible)
• Application to large surface areas
• Prolonged use
• Use of occlusive dressings
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Exfoliation of skin, xeroderma
1% to 10%: Dermatologic: Atrophic striae (3%)
Frequency not defined:
Endocrine & metabolic: Amenorrhea, HPA-axis suppression (Mazzetti 2019), hyperkalemia
Genitourinary: Polycystic ovary syndrome
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Local effects: Local adverse reactions may occur (eg, erythema, redness, pruritus, dryness, scaling) during treatment. Use with concomitant topical products (eg, medicated or abrasive soaps and cleansers, soaps and cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices, or limes) should be limited.
• Systemic effects: Absorption is increased by the use of occlusive dressings, application to large surface areas, or prolonged use.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
• Appropriate use: For external use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, and other mucous membranes. Not for use on eczematous, abraded, broken, or sunburned skin.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Winlevi: 1% (60 g) [contains cetyl alcohol, edetate (edta) disodium, polysorbate 80, propylene glycol]
No
Cream (Winlevi External)
1% (per gram): $11.66
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Winlevi: 1% (2 g, 10 g, 30 g, 60 g) [contains cetyl alcohol, edetate (edta) disodium, polysorbate 80, propylene glycol]
Topical: Clean and dry skin before applying. For topical external use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes; rinse thoroughly if accidental contact with these areas occurs. Avoid use on cuts, abrasions, and eczematous or sunburned skin.
Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Gently wash and dry the affected area, then apply a thin, uniform layer. Avoid eyes, mouth, or other mucous membranes; rinse thoroughly with water if contact occurs. Do not apply to eczematous, abraded, broken, or sunburned skin.
Acne vulgaris: Treatment of acne vulgaris in patients ≥12 years of age.
None known.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies following subcutaneous administration. Information related to topical clascoterone exposure in pregnancy is limited. Pregnant patients were excluded from the initial clinical studies and patients were removed from the trial once pregnancy was confirmed (Eichenfield 2020; Hebert 2020).
It is not known if clascoterone is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Skin irritation.
Clascoterone is an androgen receptor inhibitor that decreases sebum production and inflammation.
Protein binding: 84% to 89%.
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