Serious Warnings and Precautions
- SERIOUS INFECTIONS
Patients treated with CIBINQO may be at increased risk for developing serious bacterial, fungal, viral and opportunistic infections that may lead to hospitalization or death; more frequently reported serious infections were predominately viral. [see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS]. If a serious infection develops, interrupt CIBINQO until the infection is controlled. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see 7 WARNINGS AND PRECAUTIONS].
Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Malignancies were more frequently observed in Rheumatoid Arthritis (RA) patients in a clinical trial with another JAK inhibitor, when compared to the use of TNF inhibitors. [see 7 WARNINGS AND PRECAUTIONS].
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. In a clinical trial in RA patients 50 years of age and older, a higher rate of all-cause mortality and thrombosis occurred in patients treated with another JAK inhibitor compared to those treated with TNF inhibitors. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately [see 7 WARNINGS AND PRECAUTIONS].
- MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
MACE, including non-fatal myocardial infarction, were observed more frequently in RA patients 50 years of age and older in a clinical trial with a different JAK inhibitor compared to TNF inhibitors [see 7 WARNINGS AND PRECAUTIONS].