Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 07 February 2017

Indication(s)

1 INDICATIONS AND USAGE ACANYA® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA Gel is a lincosamide antibiotic and benzoyl peroxide indicated for the topical treatment of acne vulgaris. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS ACANYA Gel is contraindicated in: •Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. (4) •Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. (4) 4.1Hypersensitivity ACANYA 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 ACANYA Gel [see Adverse Reaction (6.2) ]. 4.2Colitis/Enteritis ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ].
Adverse reactions
6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1Clinical Trials Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice. Because clinical trials are also conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of patients treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1. Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod. Mod. = Moderate Severe Mild Mod. Severe Mild Mod. Severe Erythema 22 4 0 25 5 < 1 15 2 0 Scaling 8 < 1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 < 1 0 Burning 3 < 1 0 8 2 0 2 < 1 0 Stinging 2 < 1 0 6 1 0 1 < 1 0 6.2Postmarketing Experience Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide. Because these 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.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. •Apply a pea-sized amount of ACANYA Gel to the face once daily. (2) •Not for oral, ophthalmic, or intravaginal use. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with ACANYA Gel. ACANYA Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproductive/developmental toxicity studies have not been conducted with ACANYA Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity. 8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of ACANYA Gel in pediatric patients under the age of 12 have not been evaluated. 8.5 Geriatric Use Clinical trials of ACANYA Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.
Pregnancy and lactation
8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk after topical application of ACANYA Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ACANYA Gel while nursing, taking into account the importance of the drug to the mother.

Interactions

7 DRUG INTERACTIONS •ACANYA Gel should not be used in combination with erythromycin-containing products because of its clindamycin component. (7.1) 7.1Erythromycin ACANYA Gel should not be used 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 significance of this in vitro antagonism is not known. 7.2Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used with caution in patients receiving such agents.

More information

Category Value
Authorisation number NDA050819
Orphan designation No
Product NDC 13548-132
Date Last Revised 27-10-2016
Type HUMAN PRESCRIPTION DRUG
Storage and handling 16.3Storage and Handling •PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). •PATIENT: Store at room temperature at or below 25°C (77°F). •Protect from freezing. •Keep out of reach of children. •Keep container tightly closed.
Marketing authorisation holder Valent Pharmaceuticals North America