Acnev^®

Acnev is a preparation of Clascoterone, an androgen receptor inhibitor, in a cream base for topical dermatologic use. The mechanism of action of this cream for the topical treatment of acne vulgaris is unknown.

No Data

Acnev is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Route of administration: Acnev is for topical use only. It is not for ophthalmic, oral or vaginal use. Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Acnev® cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of the cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

Pregnancy: There are no available data on use of clascoterone in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clascoterone and any potential adverse effects on the breastfed child from it or from the underlying maternal condition.

Use in children and adolescents: Safety and effectiveness has not been established in pediatric patients under 12 years of age.

The most common side effects are erythema/redness, scaling/dryness, pruritus, stinging/buming and edema.

Clascoterone is contraindicated in patients with known hypersensitivity to it or any other components of this product.

Acnev is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

No Data

No Data

Acnev cream: Each gram cream contains Clascoterone INN 10 mg.

Storage

Keep away from the reach of children. Store in a refrigerator at 2° C to 8° C. Do not freeze & protect from light. During use store the product at room temperature (below 25° C) and discard unused portion, 30 days after first opening.

Packing

Acnev cream: Tube of 10 g.