ior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if these symptoms occur.
THROMBOSIS
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis has been observed in patients treated with oral Janus kinase inhibitors for inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly eva luated.
Thromboembolic events were observed in clinical trials with OPZELURA. There was no clear relationship between platelet count elevations and thrombotic events. OPZELURA should be used with caution in patients who may be at increased risk of thrombosis.
Thrombocytopenia, Anemia and Neutropenia
Thrombocytopenia, anemia and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.
Lipid Elevations
Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Adverse Reactions
The most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (1%). |
