CABTREO

Systemic exposure following topical application of CABTREO was evaluated in 28 subjects in an open-label, randomized, pharmacokinetic study. Subjects aged 12 years and older with moderate to severe acne vulgaris applied 2.2 ± 0.4 (mean ± SD) grams of CABTREO to the entire face (excluding eyes and lips), neck, upper chest, upper back and shoulders once daily for 28 days. Clindamycin phosphate concentrations were measurable in the majority of samples following single and repeated topical administr...

The efficacy of CABTREO was evaluated in two multicenter, randomized, double-blind clinical trials (Trial 1 and

Trial 2NCT04214639 and 2 NCT04214652, respectively) in 363 adult and pediatric subjects 10 years of age and older with facial acne vulgaris. While subjects aged 10 to less than 12 years were included in these trials, CABTREO is not approved for use in patients less than 12 years of age. Subjects were randomized 2:1 to receive CABTREO or vehicle applied once daily for 12 weeks. The trial population included 74% White, 15% Black or African American, 7% Asian, 4% Other, and <1% Native...

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...

CABTREO is contraindicated in patients with: Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any other components of CABTREO, or lincomycin [see Warnings and Precautions ( 5.1 )]. A history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, any ...

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, sti...

7 DRUG INTERACTIONS Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Use CABTREO with caution in patients receiving such agents. Neuromuscular Blocking Agents: Use CABTREO with caution in patients receiving neuromuscular blocking agents. ( 7 )