Zoryve (roflumilast)

Roflumilast 0.05% and 0.15% cream is for the treatment of mild to moderate atopic dermatitis and 0.3% cream is for the treatment of plaque psoriasis.

Roflumilast is available in cream and foam formulations and is for topical use only. Not for ophthalmic, oral, or intravaginal use.

Roflumilast cream should be rubbed in completely to the affected areas. Hands should be washed after application.

Roflumilast foam is available in a pressurized can that should be shaken well prior to each use. The foam should be applied as a thin layer to the affected areas when they are not wet and rubbed in completely. Patients should avoid fire, flame, and smoking during and immediately after application.

Store the cream and foam between 20-25degreesC (excursions permitted between 15-30degreesC). Roflumilast foam should be stored upright; do not freeze the foam. Roflumilast foam is flammable and the contents of the can are under pressure; do not puncture or incinerate. The foam should not be exposed to heat or stored at temperatures >49degreesC.

No dosing information is available for this tab.

Roflumilast is extensively metabolized via Phase 1 cytochrome P450 (CYP) enzyme and Phase II conjugation reactions. In vitro, studies suggest roflumilast metabolism is mediated by CYP1A2 and CYP3A4 enzymes. The N-oxide metabolite of roflumilast is the only major metabolite observed in human plasma. Therapeutic plasma concentrations of roflumilast and its N-oxide metabolite do not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11; therefore, interactions with these enzymes are unlikely. In vitro, studies have demonstrated no induction of CYP1A2, 2A6, 2C9, 2C19, or 3A4/5, and only weak induction of CYP2B6 by roflumilast.

No formal drug interaction studies have been conducted with topical roflumilast.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Moderate to severe liver impairment (Child-Pugh B or C).

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reactions (>=1%) in patients administered roflumilast cream for plaque psoriasis include diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infections, and urinary tract infections.

The most common adverse reactions (>=1%) in patients administered roflumilast cream for atopic dermatitis include headache, nausea, application site pain, diarrhea, and vomiting.

The most common adverse reactions (>=1%) in patients administered roflumilast foam for seborrheic dermatitis include nasopharyngitis, nausea, and headache.

The most common adverse reactions (>=1%) in patients administered roflumilast foam for plaque psoriasis of the scalp and body include headache, diarrhea, nausea, and nasopharyngitis.

There are no severe adverse reactions for this drug.

More Frequent

• Acute pain at drug application site
• Diarrhea
• Headache disorder
• Insomnia
• Upper respiratory infection
• Urinary tract infection

Less Frequent

• Conjunctivitis
• Nausea
• Pharyngitis
• Rhinitis
• Vomiting

Rare or Very Rare

• Urticaria

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The safety and effectiveness of roflumilast 0.3% cream for the treatment of plaque psoriasis, including intertriginous areas, have been established in pediatric patients ages 6 years and older. Use of roflumilast 0.3% cream in this age group is supported by data from two 8-week, vehicle-controlled, safety and efficacy trials, which included 18 pediatric patients aged 6-17 years, of whom 11 received roflumilast 0.3% cream; open-label trials of 2 and 24 weeks duration that included 18 pediatric patients (12-17 years of age); and a single 4-week, open-label, safety and pharmacokinetic study which included 20 pediatric patients (6-<12 years of age).

The safety and effectiveness of roflumilast 0.15% cream for the treatment of mild to moderate atopic dermatitis have been established in pediatric patients 6 years of age and older. Use of roflumilast 0.15% cream in this age group is supported by data from two 4-week, vehicle-controlled, safety and efficacy trials, which included 615 pediatric patients aged 6-17 years, of whom 406 received roflumilast 0.15% cream, and open-label studies involving 481 pediatric patients 6 years of age and older of which 104 patients were treated for 52 weeks.

The safety and effectiveness of roflumilast 0.05% cream for the treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2-5 years of age. Use of roflumilast 0.05% cream in this age group is supported by data from a single 4-week, vehicle-controlled, safety and efficacy trial, which included 652 pediatric patients aged 2-5 years, of whom 437 received roflumilast 0.05% cream, and open-label studies involving 572 pediatric patients 2-5 years of age of which 353 patients were treated for 52 weeks.

The safety and effectiveness of roflumilast foam for the treatment of seborrheic dermatitis have been established in pediatric patients ages 9 years and older. Use of roflumilast foam in this age group is supported by data from two 8-week, vehicle-controlled trials, which included 32 pediatric patients aged 9-17 years, of whom 17 received roflumilast foam, and open-label studies of up to 52 weeks duration involving 23 treated pediatric patients.

The safety and effectiveness of roflumilast foam for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients ages 12 years and older. Use of roflumilast foam in this age group is supported by data from two 8-week, vehicle-controlled trials, which included 12 pediatric patients aged 12-17 years, of whom 8 received roflumilast foam, and an open-label study of 8 weeks duration involving 7 treated pediatric patients (12-17 years of age).

There are insufficient data available on the use of topical roflumilast during pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, oral roflumilast administered during the period of organogenesis produced no fetal structural abnormalities at doses up to 36 and 31 times the maximum recommended human dose in rats and rabbits, respectively. Stillbirth and reduced pup viability in mice was seen at oral doses 19 and 59 times the maximum recommended human dose, respectively. Oral roflumilast has also been associated with an adverse impact on pup post-natal development.

Do not use roflumilast during labor and delivery; animal studies showed that oral roflumilast disrupted the labor and delivery process in mice.

There are no data regarding the presence of roflumilast or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

Roflumilast and/or its metabolites are excreted into the milk of lactating rats, and therefore, are likely to be present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for roflumilast and any potential adverse effects on the breastfed infant or from the underlying maternal condition.

To minimize potential exposure to the breastfed infant via breast milk, use roflumilast on the smallest area of skin and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, advise breastfeeding patients not to apply roflumilast directly to the nipple and areola. If roflumilast is applied to the patient's chest, patients should avoid direct contact with an infant's skin.

Based on available data, no dosage adjustment is warranted in geriatric patients; however, greater sensitivity of some older individuals cannot be ruled out.

In clinical trials of roflumilast cream for plaque psoriasis or atopic dermatitis, 184 patients >=65 years of age were included. In the plaque psoriasis clinical trials, 56 patients (65 to 74 years of age) and 21 patients (>=75 years of age) were treated with roflumilast 0.3% cream. In the atopic dermatitis clinical trials, 36 patients (65 to 74 years of age) and 8 patients (>=75 years of age) were treated with roflumilast 0.15% cream.

In clinical trials of roflumilast foam for seborrheic dermatitis, 98 patients were >=65 years of age and 33 patients were >=75 years of age and in trials for plaque psoriasis of the scalp and body, 82 patients were >=65 years of age and 21 patients were >=75 years of age.

No overall differences in safety or effectiveness were observed between older and younger patients across these clinical trials, but greater sensitivity of some older individuals cannot be ruled out.