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The following indications for ZORYVE (roflumilast) have been approved by the FDA:
Indications:
Atopic dermatitis
Plaque psoriasis
Seborrheic dermatitis
Professional Synonyms:
Atopic eczema
Dermatitis seborrheica
Disseminated neurodermatitis
Dyssebacea
Dyssebacia
Seborrhea corporis
Seborrheic eczema
Unna's disease
Indications:
Atopic dermatitis
Plaque psoriasis
Seborrheic dermatitis
Professional Synonyms:
Atopic eczema
Dermatitis seborrheica
Disseminated neurodermatitis
Dyssebacea
Dyssebacia
Seborrhea corporis
Seborrheic eczema
Unna's disease
The following dosing information is available for ZORYVE (roflumilast):
No enhanced Dosing information available for this drug.
For topical use only. Not for ophthalmic, oral, or intravaginal use. Rub in cream completely until no longer visible on skin.
Wash hands after application, unless roflumilast is for treatment of the hands. Store between 20-25degreesC (excursions permitted between 15-30degreesC).
Wash hands after application, unless roflumilast is for treatment of the hands. Store between 20-25degreesC (excursions permitted between 15-30degreesC).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZORYVE 0.15% CREAM | Maintenance | Adults apply to the affected area(s) by topical route once daily |
| ZORYVE 0.3% CREAM | Maintenance | Adults apply to the affected area(s) by topical route once daily |
| ZORYVE 0.3% FOAM | Maintenance | Adults apply a thin layer to the affected area(s) by topical route once daily |
No generic dosing information available.
The following drug interaction information is available for ZORYVE (roflumilast):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ZORYVE (roflumilast):
Drug contraindication overview.
*Moderate to severe liver impairment (Child-Pugh B or C).
*Moderate to severe liver impairment (Child-Pugh B or C).
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ZORYVE (roflumilast):
Adverse reaction overview.
Adverse effects reported in >=1% of patients with plaque psoriasis in clinical studies and with an incidence exceeding that of vehicle include diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections.
Adverse effects reported in >=1% of patients with plaque psoriasis in clinical studies and with an incidence exceeding that of vehicle include diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections.
There are 0 severe adverse reactions.
There are 9 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute pain at drug application site Diarrhea Headache disorder Insomnia Upper respiratory infection Urinary tract infection |
Nausea Pharyngitis |
| Rare/Very Rare |
|---|
|
Urticaria |
The following precautions are available for ZORYVE (roflumilast):
The safety and effectiveness of roflumilast have been established in pediatric patients ages 12 years and older. Use of roflumilast in this age group is supported by data from two 8-week vehicle-controlled safety and efficacy trials, which included 14 adolescent patients aged 12-17 years, of whom 8 received roflumilast. Open-label trials of 2- and 24-weeks duration were conducted in 18 adolescent patients, and the adverse reaction profile was similar to that in adults. The safety and effectiveness of roflumilast in pediatric patients below the age of 12 years have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No adequate human data are available on roflumilast use in pregnancy. In animal studies, oral roflumilast administered during the period of organogenesis produced no fetal structural abnormalities at doses up to 9 and 8 times the maximum recommended human dose. 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 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.
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.
In clinical trials, 106 subjects with psoriasis exposed to roflumilast or vehicle for up to 8 weeks were 65 years of age or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The following prioritized warning is available for ZORYVE (roflumilast):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZORYVE (roflumilast)'s list of indications:
| Atopic dermatitis | |
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| Plaque psoriasis | |
| L40.0 | Psoriasis vulgaris |
| L40.9 | Psoriasis, unspecified |
| Seborrheic dermatitis | |
| L21 | Seborrheic dermatitis |
| L21.0 | Seborrhea capitis |
| L21.1 | Seborrheic infantile dermatitis |
| L21.8 | Other seborrheic dermatitis |
| L21.9 | Seborrheic dermatitis, unspecified |
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