The following sources provide regulatory, clinical and scientific information relevant to tofacitinib.
Regulatory sources
U.S. Food and Drug Administration
The current U.S. prescribing information provides indications, dosage, boxed warnings, adverse reactions, pharmacology, interactions and monitoring requirements.
DailyMed
DailyMed provides the current U.S. labeling record for XELJANZ, XELJANZ XR and tofacitinib oral solution.
European Medicines Agency
The EMA EPAR provides European authorization and product information for Xeljanz. EMA Xeljanz EPAR
Safety sources
EMA’s JAK-inhibitor referral documents provide additional European risk-management information concerning cardiovascular events, malignancy, thrombosis and other safety considerations.
Peer-reviewed clinical evidence
The ORAL Solo trial evaluated tofacitinib in rheumatoid arthritis.
The OCTAVE program evaluated tofacitinib for induction and maintenance therapy in ulcerative colitis.
Tofacent-specific documentation
The manufacturer, authorization status and product-specific regulatory documentation for Tofacent are Incepta Pharmaceuticals Ltd..