EPSOLAY

EPSOLAY- benzoyl peroxide cream
Galderma Laboratories, L.P.

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1 INDICATIONS AND USAGE

EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.

2 DOSAGE AND ADMINISTRATION

• Before initial use, prime the pump until the first drop of cream is released.
• Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin. Avoid the eyes, lips and mouth.
• Wash hands after application.
• EPSOLAY may bleach hair or colored fabric.
• EPSOLAY is for topical use only. Not for oral, ophthalmic, or intravaginal use.
• Discard unused EPSOLAY 30 days after first use.

3 DOSAGE FORMS AND STRENGTHS

Cream, 5%. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide in a white to off-white base.

4 CONTRAINDICATIONS

EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY [see Warnings and Precautions (5.1) ].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with the use of benzoyl peroxide products. If a serious hypersensitivity reaction occurs, discontinue EPSOLAY immediately and initiate appropriate therapy.

5.2 Skin Irritation/Contact Dermatitis

Erythema, scaling, dryness and stinging/burning may be experienced with use of EPSOLAY. Irritation and contact dermatitis may occur. Apply a moisturizer and discontinue EPSOLAY if symptoms do not improve. Avoid application of EPSOLAY to cuts, abrasions, eczematous or sunburned skin.

5.3 Photosensitivity

Benzoyl peroxide may increase sensitivity to sunlight. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using EPSOLAY. Instruct the patient to implement sun protection measures (e.g., sunscreen and loose-fitting clothes) when sun exposure cannot be avoided. Discontinue EPSOLAY at the first evidence of sunburn.

6 ADVERSE REACTIONS

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 practice.

In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years.

Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle.

Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle

* Application site edema includes: application site swelling and application site edema
	EPSOLAY N=488	Vehicle N=234
Application site pain	11 (2%)	2 (1%)
Application site erythema	11 (2%)	2 (1%)
Application site pruritus	6 (1%)	1 (<1%)
Application site edema*	4 (1%)	0 (0%)

During the clinical trials, local tolerability evaluations were conducted at baseline and at each study visit by assessment of dryness, itching, scaling and stinging/burning. Table 2 presents the local tolerability assessments by severity grade at Week 12.

Table 2: Facial Cutaneous Tolerability Assessment

* Of the 488 subjects treated with EPSOLAY, 455 subjects had local tolerability assessments at Week 12.
Sign/Symptom	EPSOLAY N=455*
	Severity at Week 12
	Mild	Moderate	Severe
Dryness	25%	7%	0%
Itching	24%	6%	0%
Scaling	13%	4%	0%
Stinging/Burning	20%	3%	1%

In a 40-week open-label extension safety study (for a total of up to 52 weeks of treatment) the frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Hence, maternal use is not expected to result in fetal exposure to the drug. Animal reproductive studies have not been conducted with EPSOLAY or benzoyl peroxide.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2 Lactation

Risk Summary

There are no data on the presence of benzoyl peroxide in human milk, its effects on the breastfed infant or its effects on milk production. The systemic exposure of benzoyl peroxide is unknown. Based on the published literature, benzoyl peroxide is metabolized to benzoic acid (an endogenous substance), which is eliminated in the urine. Any amount of benzoyl peroxide excreted into human milk by a nursing mother would be expected to be metabolized by tissue and stomach esterases. Therefore, breastfeeding is not expected to result in exposure of the infant to EPSOLAY. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EPSOLAY and any potential adverse effects on the breastfed child from EPSOLAY or from the underlying maternal condition.