Product Dossier
VELSIPITY
Product Dossier for VELSIPITY (etrasimod, Pfizer). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Pfizer
- Active ingredient: etrasimod
- Therapeutic area: Gastroenterology
- Same area: SALOFALK
- Same area: COLOFAC
What it is
VELSIPITY contains etrasimod . Each film-coated tablet contains 2.762 mg of etrasimod arginine, equivalent to 2 mg etrasimod . Etrasimod is an S1P receptor modulator .
Approved indications
— Treatment of adults with moderately to severely active ulcerative colitis who have had inadequate response, loss of response or intolerance to conventional, biologic or Janus kinase (JAK) inhibitor therapies .
Dosing overview
The recommended dose of VELSIPITY is 2 mg taken orally once daily .
Key safety warnings
Safety concerns identified include cardiac effects and infections . Treatment with VELSIPITY should be initiated under the supervision of a physician experienced in the management of conditions for which VELSIPITY is indicated .
Regulatory history
VELSIPITY received TGA approval on 17 May 2024 . ARTG registration was first listed on 22 May 2024 . The PBAC recommended VELSIPITY for treatment of ulcerative colitis (moderate to severe) in March 2024 .