ONEXTON

ONEXTON- clindamycin phosphate and benzoyl peroxide gel
Bausch Health US, LLC

1 INDICATIONS AND USAGE

ONEXTON® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

Before applying ONEXTON Gel, wash the face gently with a mild soap, rinse with warm water, and pat the skin dry. Apply a pea-sized amount of ONEXTON Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin.

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

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

3 DOSAGE FORMS AND STRENGTHS

Gel, 1.2%/3.75%

Each gram of ONEXTON Gel contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin, and 37.5 mg (3.75%) benzoyl peroxide in a white to off-white, opaque, smooth gel.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ONEXTON Gel [see Postmarketing Experience (6.2)].

4.2 Colitis/Enteritis

ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, ONEXTON Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin 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.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2 Ultraviolet Light and Environmental Exposure

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

5.3 Concomitant Topical Medications

Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

6 ADVERSE REACTIONS

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)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates observed in clinical trials of another drug and may not reflect the rates observed in clinical practice.

These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around Week 4 and were near or improved from baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.

Table 1: Percent of Subjects with Local Skin Reactions. Results from the Phase 3 Trial (N = 243)
Before Treatment (Baseline) During Treatment End of Treatment (Week 12)
Mild Mod. * Severe Mild Mod. * Severe Mild Mod. * Severe
*
Mod. = Moderate

Erythema

20

6

0

28

5

<1

15

2

0

Scaling

10

1

0

19

3

0

10

˂1

0

Itching

14

3

˂1

15

3

0

7

2

0

Burning

5

<1

˂1

7

1

˂1

3

<1

0

Stinging

5

<1

0

7

0

˂1

3

0

˂1

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