ROFLUMILAST FOAM,TOP
Clinical Criteria Summary
Document 637
Exclusion Criteria
- Moderate to severe liver impairment (Child-Pugh B or C)
Inclusion Criteria
- Moderate to severe seborrheic dermatitis
- Prescribed and monitored by a VA / VA Community Care dermatologist or locally designated expert
- Tried and had intolerance or inadequate response to a combination of topical antifungal (including shampoo) plus topical corticosteroid for ≥ 4 consecutive weeks unless medically inadvisable
- Tried and had intolerance or inadequate response to a combination of topical antifungal (including shampoo) plus topical calcineurin inhibitor (e.g., tacrolimus ointment or pimecrolimus cream) for ≥ 4 consecutive weeks unless medically inadvisable
Additional Inclusion Criteria (Special Populations)
- Pregnancy/Planning pregnancy: Counseling provided on potential risks vs benefits of treatment; patient informed that it is not known whether use will harm the unborn baby. Avoid use during labor and delivery.
- Breastfeeding/Planning breastfeeding: Counseling provided on how to minimize potential drug exposure to the breastfed infant via breast milk per prescribing information. Advise patients not to apply directly to the nipple or areola, and if applied to the chest, to avoid direct contact with the infant’s skin.
Document 652
Indication & Patient Population
- Treatment of seborrheic dermatitis (SD) in adults
- Moderate to severe SD (predominantly moderate disease severity)
- Patients with an inadequate response, intolerance, or medical inadvisability to combination topical antifungal plus TCS and combination topical antifungal plus topical calcineurin inhibitor
Place in Therapy & Step Requirements
- 2nd-line alternative for SD of the face in patients requiring frequent use of TCSs
- May be added to topical antifungal therapy
- Alternative to a TCI for maintenance therapy
- First nonsteroidal, non-antifungal product approved for the treatment of SD
Dosage & Administration Parameters
- Applied once daily to affected areas on skin and/or scalp when not wet
- Topical foam 0.3% in 60-gram pressurized cans
- Maximum body surface area (BSA) of 20%
Safety & Contraindications
- Contraindicated in moderate to severe liver impairment (Child-Pugh B or C)
- Flammable formulation requiring appropriate handling precautions
- PDE4-related adverse events (psychiatric and gastrointestinal) occurred at significantly lower rates than vehicle
- Local adverse events occurred at similar rates to vehicle