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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity : If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy. ( 5.1 ) Colitis : Clindamycin can cause severe colitis, which may result in death. Discontinue CABTREO if diarrhea occurs. ( 5.2 ) Photosensitivity : Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing when sun exposure cannot be avoided. ( 5.3 ) Skin Irritation and Allergic Contact Dermatitis : Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of CABTREO and may necessitate discontinuation ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with use of clindamycin phosphate, benzoyl peroxide, and adapalene [see Adverse Reactions ( 6.2 )]. If a serious hypersensitivity reaction occurs, discontinue CABTREO immediately and initiate appropriate therapy. 5.2 Colitis Diarrhea, bloody diarrhea, and colitis have been reported with the use of topical and systemic clindamycin. Severe colitis has occurred with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death. Discontinue CABTREO if diarrhea occurs. 5.3 Photosensitivity CABTREO may increase sensitivity to ultraviolet light. Avoid or minimize sun exposure (including use of tanning beds, and sun lamps) following CABTREO application. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided. 5.4 Skin Irritation and Allergic Contact Dermatitis Stinging/burning/pain, erythema, dryness, irritation, exfoliation, and dermatitis have been reported with use of CABTREO. These application site adverse reactions occurred at a greater frequency in CABTREO-treated subjects than in vehicle-treated subjects. These adverse reactions are most likely to occur during the first four weeks of treatment [ see Adverse Reactions ( 6.1 )] . Irritant and allergic contact dermatitis have been reported with use of CABTREO. Weather extremes, such as wind or cold, may be irritating to patients under treatment with CABTREO. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of CABTREO, or discontinue use. Avoid applying CABTREO to areas of broken, eczematous, or sunburned skin. Avoid use of “waxing” as a depilatory method on skin treated with CABTREO. Avoid concomitant use of other potentially irritating topical products such as peeling, desquamating, or abrasive agents and products with high concentrations of alcohol, astringents, spices, or limes. Use of CABTREO with concomitant topical acne therapy has not been evaluated.
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [ see Warnings and Precautions ( 5.1 )] Colitis [see Warnings and Precautions ( 5.2 )] Skin Irritation and Allergic Contact Dermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (occurring in >1% of the CABTREO group and greater than the vehicle group) were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or 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 clinical practice. In two multicenter, randomized, double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 363 adult and pediatric subjects 10 years of age and older with facial acne vulgaris were treated with CABTREO or vehicle topically once daily for 12 weeks [see Clinical Studies ( 14 )] . Adverse reactions reported by >1% of subjects treated with CABTREO and more frequently than subjects treated with vehicle are summarized in Table 1. These adverse reactions were mild (59%), moderate (36.4%), and severe (4.5%). Overall, 2.5% (6/242) of subjects discontinued CABTREO because of local skin reactions. Table 1: Adverse Reactions Reported by >1% of Subjects with Facial Acne Vulgaris Treated with CABTREO (and More Frequently than Vehicle) in Trials 1 and 2 Adverse Reactions N (%) CABTREO N=242 Vehicle N=121 Application site pain Application site pain also includes application site stinging and burning 33 (13.6) 1 (0.8) Application site erythema Application site erythema also includes erythema 11 (4.5) 0 Application site dryness Application site dryness also includes xerosis 10 (4.1) 1 (0.8) Application site irritation 5 (2.1) 0 Application site exfoliation 4 (1.7) 0 Application site dermatitis 3 (1.2) 0 Local tolerability evaluations were conducted at each study visit by assessment of erythema, scaling, itching, burning, and stinging. Table 2 presents the signs and symptoms of local facial tolerability during the 12 Week treatment period in subjects treated with CABTREO. Table 2: Facial Cutaneous Tolerability Assessment During 12-Week Treatment Period in Subjects with Acne Vulgaris Treated with CABTREO in Trials 1 and 2 Maximum During Treatment The denominators for calculating the percentages were the number of subjects with at least one post-baseline cutaneous tolerability assessment. Week 12 (End of Treatment) The denominators for calculating the percentages were the number of subjects with Week 12 assessment. Mild (%) Mod (%) Severe (%) Mild (%) Mod (%) Severe (%) CABTREO (N = 242) Erythema 34.2 19.7 2.1 22.4 6.5 0.5 Burning 29.6 10.7 3.0 4.2 1.4 0.9 Scaling 26.7 3.4 0 7.0 0.9 0 Itching 24.3 3.4 0.4 6.0 0.9 0 Stinging 20.5 5.1 2.6 2.3 0.9 0.5 Vehicle (N = 121) Erythema 22.5 21.7 1.7 25.5 5.5 0 Burning 2.5 0.8 0.8 0.9 0 0 Scaling 12.5 0 0 4.5 0 0 Itching 11.6 0.8 0 1.8 0 0 Stinging 3.3 0.8 0 1.8 0 0 Local tolerability scores for erythema, scaling, itching, burning, and stinging increased during the first two weeks of treatment and decreased thereafter. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing clindamycin phosphate, adapalene, and benzoyl peroxide as the active ingredients. Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders: anaphylaxis and allergic reactions including eyelid edema, throat tightness, swelling of the face, and eczema. [see Contraindications ( 4 )] . Local Adverse Reactions: sunburn, blister, pruritis, hyperpigmentation and hypopigmentation. Gastrointestinal Disorders: abdominal pain and gastrointestinal disturbances. Bacterial infections: gram negative folliculitis
adverse reactions table
<table ID="_RefID0EBAAE" width="100%"><caption>Table 1: Adverse Reactions Reported by >1% of Subjects with Facial Acne Vulgaris Treated with CABTREO (and More Frequently than Vehicle) in Trials 1 and 2</caption><col width="37%"/><col width="33%"/><col width="30%"/><thead><tr><th align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="bottom"><content styleCode="bold">Adverse Reactions</content> <content styleCode="bold">N (%)</content></th></tr><tr><th align="left" styleCode="Rrule Lrule Botrule " valign="bottom"/><th align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><content styleCode="bold">CABTREO</content> <content styleCode="bold">N=242</content></th><th align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><content styleCode="bold">Vehicle</content> <content styleCode="bold">N=121</content></th></tr></thead><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="bottom"><paragraph>Application site pain <footnote ID="_Ref149047667">Application site pain also includes application site stinging and burning</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="bottom"><paragraph>33 (13.6)</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="bottom"><paragraph>1 (0.8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Application site erythema <footnote ID="_Ref149040286">Application site erythema also includes erythema</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>11 (4.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Application site dryness <footnote ID="_Ref149040293">Application site dryness also includes xerosis</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>10 (4.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>1 (0.8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Application site irritation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>5 (2.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Application site exfoliation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>4 (1.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>0</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>Application site dermatitis</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>3 (1.2)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>0</paragraph></td></tr></tbody></table>