Regulatory Sources
U.S. FDA / DailyMed — OPZELURA
Current labeling for OPZELURA provides information on topical ruxolitinib, including indications, dosing, warnings, clinical pharmacology and adverse reactions.
U.S. FDA / DailyMed — JAKAFI
Current JAKAFI/JAKAFI XR labeling provides information about oral ruxolitinib, including myelofibrosis, polycythemia vera and graft-versus-host disease.
European Medicines Agency — Jakavi
EMA information describes ruxolitinib use in myelofibrosis, polycythemia vera and graft-versus-host disease within the European regulatory framework.
Manufacturer and Originator Sources
Incyte developed the oral ruxolitinib product associated with Jakafi and continues to be identified as the U.S. labeler/packager for JAKAFI and OPZELURA.
Clinical Literature
Clinical evidence should be separated according to:
- topical ruxolitinib
- oral ruxolitinib
- myelofibrosis
- polycythemia vera
- graft-versus-host disease
- atopic dermatitis
- vitiligo
The website should identify the formulation represented by each study.