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WINLEVI is a brand name for Clascoterone, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: WINLEVI (clascoterone) is indicated for: • the topical treatment of acne vulgaris in patients 12 years of age and older. 1.1 Pediatrics Pediatrics (12 to <18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of WINLEVI in pediatric patients aged 12 to <18 years have been…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations WINLEVI is for external use only. WINLEVI is not for ophthalmic, oral or vaginal use. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. 2 Recommended Dose and Dosage Adjustment The recommended dose per application is up to approximately 1 gram, which corresponds to 2 fingertip units.
The recommended dosing regimen for WINLEVI is to apply a thin uniform layer of cream twice per day, in the morning and the evening, over the area prone to acne, as instructed by a health professional. Do not spot treat for optimal efficacy.
4 Administration Cleanse the entire area to be treated and dry gently. After the skin is dry, apply a thin uniform layer of WINLEVI twice per day, in the morning and in the evening, over the area prone to acne, as instructed by a health professional.
The recommended dose per application is up to approximately 1 gram, which corresponds to 2 fingertip units. 5 g) is the amount of cream squeezed along the index finger from the tip to the first joint. When spread on the skin, the cream is expected to cover an area WINLEVI® (clascoterone) Page 5 of 21 approximately the size of two adult palms or one adult face.
Hands should be washed before and after applying WINLEVI cream. Avoid accidental transfer of WINLEVI into eyes, lips, mouth, corners of the nose, or other mucous membranes. If contact with mucous membranes occurs, rinse immediately and thoroughly with water.
5 Missed Dose If patients forget to take a dose of WINLEVI, they should be instructed to apply the next dose at the usual time. Patients should be instructed to not apply a double dose to make up for forgotten doses.
1 Adverse Reaction Overview In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 patients 12 years and older with facial acne vulgaris applied WINLEVI or vehicle (placebo cream) twice daily to the entire face for 12 weeks.
4%). Most of the treatment-emergent LSRs were trace or mild in severity. 2 Pharmacodynamics). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates were observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. There were no adverse events reported as adverse drug reactions in > 1% of patients.
Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of patients treated with vehicle.
Local skin reactions reported by ≥ 1% of patients treated with WINLEVI are shown in the following table. 8) * Local Skin Reactions (LSRs) are defined in the clinical trials by the adverse events identified in the above table. Causality assessment was not completed for LSRs.
a Pooled Data of Trial 1 and Trial 2; The median age of patients who experienced new or worsening LSRs is 18 years of age (age range: 12 to 50 years of age). b The denominators for calculating the percentages were the 674 of 709 patients treated with WINLEVI and 656 of 712 patients treated with vehicle in these trials who had local skin reaction results reported after Day 1.
1 Clinical Trial Adverse Reactions – Pediatrics In the pooled Phase 3 studies, in patients aged 12 to <18 years of age, there were no adverse reactions reported in > 1% of patients. 3% vehicle). 3 Less Common Clinical Trial Adverse Reactions The following adverse reactions associated with the use of WINLEVI were identified in clinical trials and the long-term safety study.
General WINLEVI is for external use only. Not for ophthalmic, oral or vaginal use. WINLEVI should not be applied to cuts, abrasions, eczematous or sunburned skin. Avoid accidental transfer of WINLEVI into eyes, lips, mouth, corners of the nose, or other mucous membranes.
If contact with mucous membranes occurs, rinse immediately and thoroughly with water. Endocrine and Metabolism Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone.
2 Route of Administration Dosage Form / Strength Non-medicinal Ingredients Topical Cream / 1% w/w Cetyl alcohol, citric acid monohydrate, edetate disodium, DL- alpha tocopherol (vitamin E), mineral oil, mono- and di- glycerides, polysorbate 80, propylene glycol, and water WINLEVI® (clascoterone) Page 6 of 21 Pharmacodynamics).
Conditions which augment systemic effects include use over large surface areas, prolonged use, concomitant use of corticosteroid-containing products, and the use of occlusive dressings. Pediatric patients may be more susceptible. If HPA axis suppression is suspected, consider withdrawing the drug.
Reproductive Health:
Female and Male Potential See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology. Skin WINLEVI may induce local irritation (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia).
Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited.
1 Pregnant Women There are no available data on the use of WINLEVI in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of clascoterone to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the MRHD, respectively, increased malformations in rats and post-implantation loss and resorptions in rabbits (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
WINLEVI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The events are categorized by body system. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics In clinical trials, the types of adverse reactions seen with WINLEVI were comparable in adult and pediatric patients. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Clinical laboratory evaluations were not performed in the Phase 3 studies.
5 Post-Market Adverse Reactions Not applicable.
2 Breast-feeding No studies were conducted to determine the presence of clascoterone or its metabolite in human or animal milk, the effects on the breastfed infant or the effects on milk production. It is unknown if the drug is excreted in human milk.
Precaution should be exercised because many drugs are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical benefit from clascoterone and any potential adverse effects on the breastfed child from clascoterone.
3 Pediatrics Pediatric patients may be more susceptible to systemic toxicity than adults when treated with WINLEVI. 1 Clinical Trials by Indication). The safety and efficacy of WINLEVI have not been established in pediatric patients under 12 years of age.
In a Phase 2 maximum use clinical study with WINLEVI administered at 4 to 6 times above the recommended daily dose for up to 2 weeks (and twice the maximal dose in the controlled trials on the face), biochemical HPA axis suppression was observed in 2/22 (9%) adolescent patients aged 12 to <18 years.
2 Pharmacodynamics).
WINLEVI® (clascoterone) Page 7 of 21 Pediatrics (<12 years):
WINLEVI is not authorized in pediatric patients under 12 years of age. 2 Pharmacodynamics). 4 Geriatrics Clinical studies of WINLEVI did not include patients aged 65 years of age and over to determine whether they respond differently from younger patients.