TWYNEO

TWYNEO- tretinoin and benzoyl peroxide cream
Galderma Laboratories, L.P.

bpo-chemical-structuretretinoin-chemical-structure30g_pump_carton_image

1 INDICATIONS AND USAGE

TWYNEO Cream is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

2 DOSAGE AND ADMINISTRATION

  • Apply a thin layer of TWYNEO Cream to the affected areas once daily on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes.
  • Wash hands after application.
  • TWYNEO Cream is for topical use only. TWYNEO Cream is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%/3%: Each gram of TWYNEO Cream contains 1mg (0.1%) of tretinoin and 30 mg (3%) of benzoyl peroxide in a yellow cream in a 30-gram bottle with a pump.

4 CONTRAINDICATIONS

TWYNEO Cream is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of TWYNEO Cream [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

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

5.2 Skin Irritation

Patients using TWYNEO Cream may experience application site dryness, pain, exfoliation, erythema, dermatitis, pruritus, and irritation [see Adverse Reactions (6.1)]. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of TWYNEO Cream, or discontinue use. Avoid application of TWYNEO Cream to cuts, abrasions, eczematous, or sunburned skin.

5.3 Photosensitivity

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

6 ADVERSE REACTIONS

6.1 Clinical trials experience

The following adverse reactions are discussed in greater detail elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates are 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 multicenter, randomized, double-blind, vehicle-controlled trials (Trial 1 and 2), 832 subjects 9 years of age and older with facial acne vulgaris applied TWYNDO Cream (N=555) or vehicle (N=277) daily for 12 weeks. The majority of subjects were White (73%) and female (59%). Approximately 33% were Hispanic/Latino, and 46% were younger than 18 years of age. Adverse reactions reported in ≥ 1.0% of subjects treated with TWYNEO Cream (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with vehicle are presented in Table 1.

Table 1:Adverse Reactions Reported by ≥ 1% of Subjects with Facial Acne Vulgaris Treated with TWYNEO Cream and More Frequently than Vehicle in Trials 1 and 2
TWYNEO Cream(N = 555)n (%) Vehicle Cream(N = 277)n (%)
Application Site Pain* 59 (10.6) 1 (0.4)
Application Site Dryness 27 (4.9) 1 (0.4)
Application Site Exfoliation 23 (4.1) 0
Application Site Erythema 22 (4.0) 0
Application Site Dermatitis 7 (1.3) 1 (0.4)
Application Site Pruritus 7 (1.3) 0
Application Site Irritation 6 (1.1) 1 (0.4)

* Application site pain defined as application site stinging, burning or pain.

Local tolerability evaluations were conducted at each study visit in the clinical trial by assessment of erythema, scaling, pigmentation, dryness, itching, burning and stinging. Table 2 presents the active assessment of the signs and symptoms of local facial tolerability at Week 12 in subjects treated with TWYNEO Cream.

Table 2. Facial Cutaneous Tolerability Assessment at Week 12 in Subjects with Acne Vulgaris Treated with TWYNEO Cream
TWYNDEO Cream(N=494*)(%) Vehicle(N = 264*)(%)
Mild Moderate Severe Mild Moderate Severe
Erythema 33.0 6.9 0.2 26.9 8.0 0
Pigmentation 27.3 6.3 0.4 26.5 4.5 0
Dryness 22.3 5.3 0.4 16.7 2.3 0
Scaling 16.4 2.6 0 12.9 0.8 0
Burning 5.9 2.2 0 3.4 0.8 0
Itching 11.1 1.8 0 8.7 2.7 0
Stinging 5.3 0.2 0 1.9 1.1 0

* The denominators for calculating the percentages were 494 of 555 subjects treated with TWYNEO Cream and 264 of 277 subjects treated with vehicle in these trials who had cutaneous signs and local tolerability results reported at Week 12.

Local tolerability scores for erythema, scaling, dryness, itching, burning and stinging rose during the first two weeks of treatment and decreased thereafter.

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