Product Dossier
STAQUIS
Product Dossier for STAQUIS (crisaborole, Pfizer). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Pfizer
- Active ingredient: crisaborole
- Therapeutic area: Dermatology
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
STAQUIS contains 2% (w/w) crisaborole in a paraffin-based ointment for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor. Each gram of STAQUIS contains 20 mg of crisaborole.
Approved indications
— Topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.
Dosing overview
STAQUIS is to be applied as a thin layer twice daily to affected areas. STAQUIS can be used on all skin areas, including the head and face, neck and intertriginous areas. For children and adolescents (2–17 years) the dosage is the same as for adults. STAQUIS can be used continuously for up to 28 days per treatment course. The efficacy for continuous use beyond 28 days has not been studied in a controlled trial.
Key safety warnings
Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with STAQUIS. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. If signs and symptoms of hypersensitivity occur, discontinue STAQUIS immediately and initiate appropriate therapy. In the 28-day pivotal trials, application site pain (e.g., burning or stinging) was the only treatment-related adverse event that showed a clinically relevantly higher rate in STAQUIS-treated groups versus vehicle-treated groups in subjects with atopic dermatitis. Generally, application site pain was noted early in the treatment period and was transient in nature, resolving spontaneously.
Contraindications
STAQUIS is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation.
PBS listing
No information on PBS listing is provided in the source documents.
Regulatory history
Staquis (crisaborole) was approved by the TGA on 15 February 2019 and registered on the ARTG on 20 February 2019 for the topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older. The black triangle was removed as of 10 January 2025.