Zonyra Cream 0.005%

Zonyra Cream

Generic Name: Trifarotene

Strength: 0.005%

Dosage Form: Cream

Manufacturer: Ziska Pharmaceuticals Ltd

Indications

Zonyra cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Pharmacology

Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which Trifarotene ameliorates acne is unknown.

Dosage Information

Apply a thin layer of Trifarotene cream to the affected areas once daily, in the evening, on clean and dry skin. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. Trifarotene cream is intended for topical use only. Not for oral, ophthalmic or intravaginal use.

Side Effects

Most common adverse reactions (incidence >1%) in patients treated with Zonyra cream were application site irritation, application site pruritus, and sunburn.

Precautions

Skin irritation: Patients using Zonyra cream may experience erythema, scaling, dryness and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of Zonyra cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued. Avoid application of Zonyra cream to cuts, abrasions, or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with Zonyra cream.

Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with Zonyra cream. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Apply a thin layer of Trifarotene cream to the affected areas once daily, in the evening, on clean and dry skin. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. Trifarotene cream is intended for topical use only. Not for oral, ophthalmic or intravaginal use.

Most common adverse reactions (incidence >1%) in patients treated with Zonyra cream were application site irritation, application site pruritus, and sunburn.

Pregnancy Category C. Available data from clinical trials with Trifarotene cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trifarotene cream and any potential adverse effects on the breastfed infant from Trifarotene cream or from the underlying maternal condition.

Skin irritation: Patients using Zonyra cream may experience erythema, scaling, dryness and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of Zonyra cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued. Avoid application of Zonyra cream to cuts, abrasions, or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with Zonyra cream.

Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with Zonyra cream. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Pediatric Use: Safety and effectiveness of Zonyra cream have not been established in pediatric patients below the age of 9 years.

Geriatric Use: Clinical trials of Zonyra cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.