ONEXTON

The systemic absorption of ONEXTON Gel has not been evaluated. The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of a marketed gel containing clindamycin 1%/benzoyl peroxide 2.5% applied to the face once daily for 30 days. This product has the same formulation as ONEXTON Gel but with a lower concentration of benzoyl peroxide. Twelve subjects (75%) had at least one quantifiab...

The safety and efficacy of once-daily use of ONEXTON Gel was assessed in a 12-week multi-center, randomized, blinded trial in subjects 12 years and older with moderate to severe acne vulgaris. This trial evaluated ONEXTON Gel compared to vehicle gel. The co-primary efficacy variables for this trial were: (1) Mean absolute change from baseline at Week 12 in:

• Inflammatory lesion counts
• Non-inflammatory lesion counts (2) Percent of subjects who had a 2-grade reduction from baseline on an Evaluator’s Global Severity (EGS) score. The EGS scoring scale used in the clinical trial for ONEXTON Gel ...

The following adverse reaction is described in more detail in the Warnings and Precautions section of the label:

• Colitis [see Warnings and Precautions (5.1) ] . The most common adverse reactions are: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%). ( 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 conduct...

ONEXTON Gel is contraindicated in:

• Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4.1 )
• Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2 ) 4.1 Hypersensitivity ONEXTON Gel is contraindicated in those individuals who have shown hype...

• Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. ONEXTON Gel should be discontinued if significant diarrhea occurs. ( 5.1 )
• Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. ( 5.2 ) 5.1 Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bl...

7 DRUG INTERACTIONS Avoid using ONEXTON Gel in combination with topical or oral erythromycin-containing products because of its clindamycin component. ( 7.1 ) 7.1 Erythromycin Avoid using ONEXTON Gel in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical signifi...