Ruxolitinib (Topical application)

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and ThrombosisSerious InfectionsPatients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalizations or death.Reported infections include: active tuberculosis, which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including candidiasis and pneumocystosis; and bacterial, viral, and other infections due to opportunistic pathogens.Avoid use of ruxolitinib in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt ruxolitinib until the infection is controlled.The risks and benefits of treatment with ruxolitinib should be carefully considered prior to initiating therapy in patient with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ruxolitinib.MortalityHigher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with oral Janus kinase inhibitors for inflammatory conditions.MalignanciesLymphoma and other malignancies have been observed in patients with Janus kinase inhibitors for inflammatory conditions.Major Adverse Cardiovascular Events (MACE)Higher rate MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.ThrombosisThrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis has been observed at an increased incidence in patients treated with oral Janus kinase inhibitors for inflammatory conditions compared to placebo. Many of these adverse reactions were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated .