Acanya

ACANYA^® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Before applying ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry.

Apply a pea-sized amount of ACANYA Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin.

Use of ACANYA Gel beyond 12 weeks has not been evaluated.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents.

ACANYA Gel is not for oral, ophthalmic, or intravaginal use.

Gel, 1.2%/2.5%

Each gram of ACANYA Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel.

There are no available data on ACANYA Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g ACANYA Gel, based on body surface area (BSA) comparisons

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy.

Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

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  Colitis:
  Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. ACANYA Gel should be discontinued if significant diarrhea occurs.
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  Ultraviolet Light and Environmental Exposure:
  Minimize sun exposure following drug application. (
  5.2 Ultraviolet Light and Environmental Exposure

  Minimize sun exposure including use of tanning beds or sun lamps following drug application.
  )