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warnings and cautions
5 WARNINGS AND PRECAUTIONS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. ( 5.1 ) Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. ( 5.2 ) Attempt to withdraw use if HPA axis suppression develops. ( 5.2 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.2 , 8.4 ) Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. ( 12.2 ) 5.1 Local Skin Reactions WINLEVI cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). 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. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. 5.2 Hypothalamic-pituitary-adrenal (HPA) Axis Suppression Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. In the PK trial, all subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment [see Clinical Pharmacology (12.2) ]. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. If HPA axis suppression develops, an attempt should be made to withdraw the drug. Pediatric patients may be more susceptible to systemic toxicity.
6 ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied WINLEVI cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years. 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 subjects treated with vehicle. Local skin reactions reported by ≥ 1% of subjects treated with WINLEVI cream are shown in the following table. Table 1. Incidence of New or Worsening Local Skin Reactions Reported by ≥ 1% of Subjects Treated with WINLEVI Cream After Day 1 in 12-Week Controlled Clinical Trials WINLEVI Cream 1% (N=674 a ) Vehicle Cream (N=656 a ) a The denominators for calculating the percentages were the 674 of 709 subjects treated with WINLEVI cream and 656 of 712 subjects treated with vehicle in these trials who had local skin reaction results reported after Day 1. Edema 24 (3.6%) 23 (3.5%) Erythema/redness 82 (12.2%) 101 (15.4%) Pruritus 52 (7.7%) 54 (8.2%) Scaling/dryness 71 (10.5%) 68 (10.4%) Skin atrophy 11 (1.6%) 17 (2.6%) Stinging/burning 28 (4.2%) 28 (4.3%) Striae rubrae 17 (2.5%) 10 (1.5%) Telangiectasia 8 (1.2%) 12 (1.8%) The following adverse reactions associated with the use of WINLEVI cream were identified in clinical trials and long-term safety studies. Metabolism: hyperkalemia [see Clinical Pharmacology (12.2) ] Reproductive: polycystic ovaries, amenorrhea.
adverse reactions table
<table width="100%"><col width="34%" align="left" valign="middle"/><col width="33%" align="left" valign="middle"/><col width="33%" align="left" valign="middle"/><thead><tr><td align="center" styleCode="Botrule Lrule Rrule Toprule"/><td align="center" styleCode="Botrule Rrule Toprule"><paragraph>WINLEVI Cream 1% (N=674 <sup>a</sup>) </paragraph></td><td align="center" styleCode="Botrule Rrule Toprule"><paragraph>Vehicle Cream (N=656 <sup>a</sup>) </paragraph></td></tr></thead><tfoot><tr><td colspan="3" align="left" valign="top"><paragraph><sup>a</sup>The denominators for calculating the percentages were the 674 of 709 subjects treated with WINLEVI cream and 656 of 712 subjects treated with vehicle in these trials who had local skin reaction results reported after Day 1. </paragraph></td></tr></tfoot><tbody><tr><td styleCode="Botrule Lrule Rrule Toprule"><paragraph>Edema</paragraph></td><td align="center" styleCode="Botrule Rrule Toprule"><paragraph>24 (3.6%)</paragraph></td><td align="center" styleCode="Botrule Rrule Toprule"><paragraph>23 (3.5%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Erythema/redness</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>82 (12.2%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>101 (15.4%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Pruritus</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>52 (7.7%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>54 (8.2%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Scaling/dryness</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>71 (10.5%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>68 (10.4%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Skin atrophy</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>11 (1.6%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>17 (2.6%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Stinging/burning</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>28 (4.2%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>28 (4.3%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Striae rubrae</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>17 (2.5%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>10 (1.5%)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule"><paragraph>Telangiectasia</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>8 (1.2%)</paragraph></td><td align="center" styleCode="Botrule Rrule"><paragraph>12 (1.8%)</paragraph></td></tr></tbody></table>