How the product works
Tofacitinib is a Janus kinase (JAK) inhibitor. It acts on intracellular signaling pathways involved in the transmission of signals from several inflammatory cytokines. By inhibiting JAK-dependent signaling, tofacitinib reduces excessive immune activity and inflammation.
Who may be prescribed this medicine
Clinical studies and evidence
Tofacitinib has been evaluated in extensive clinical development programs for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Clinical studies demonstrated its ability to reduce disease activity and improve symptoms and physical function in appropriate patient populations.
Long-term safety research is also important when considering treatment. The ORAL Surveillance study in patients with rheumatoid arthritis and cardiovascular risk factors found higher rates of major cardiovascular events and certain malignancies compared with TNF inhibitors. Based on these findings, the FDA strengthened safety warnings for tofacitinib and other JAK inhibitors.
Current prescribing information includes prominent warnings concerning serious infections, mortality, malignancies, major cardiovascular events, and thrombosis. Treatment therefore requires individualized risk assessment and appropriate medical monitoring.
Tofacitinib is used to suppress abnormal inflammatory immune responses in certain chronic immune-mediated diseases.
Approved indications include:
The medicine inhibits JAK enzymes involved in inflammatory cytokine signaling, thereby reducing excessive immune-system activity and inflammation.
Tablets are taken orally with water and may generally be taken with or without food unless otherwise directed by a healthcare professional. The dose and treatment duration are individualized according to the underlying condition, treatment response, kidney and liver function, concomitant medications, and individual risk factors. Different diseases and clinical circumstances require different dosing regimens, so treatment should be prescribed by a healthcare professional.
Before treatment, healthcare professionals may evaluate infections including tuberculosis, blood counts, liver function, and other relevant risk factors. Appropriate monitoring should continue during therapy.
Side Effects
The risks of serious infection, thrombosis, cardiovascular complications, and certain malignancies require careful assessment before treatment is initiated.
