Topical application route (Cream)

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 cryptococcosis, and pneumocystosis; and bacterial, viral, including herpes zoster, 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 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 ruxolitinib.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.MalignanciesMalignancies were reported in patients treated with ruxolitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.Major Adverse Cardiovascular Events (MACE)In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE)(defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue ruxolitinib in patients who have experienced a myocardial infarction or stroke.ThrombosisThromboembolic events were observed in trials with ruxolitinib. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid ruxolitinib in patients at risk. If symptoms of thrombosis occur, discontinue ruxolitinib and treat appropriately.