Leqselvi

Serious Infections

incr. risk of serious bacterial, fungal, viral, and opportunistic infection, including TB, leading to hospitalization or death; interrupt tx if serious infection occurs, and tx infection until resolved before resuming deuruxolitinib; avoid use in patients with active, serious infection, including active TB; screen for latent TB infection and initiate anti-TB tx before deuruxolitinib tx start; weigh risk/benefit before tx in patients with chronic or recurrent infection, serious or opportunistic infection history, underlying conditions predisposing to infections, and in patients exposed to TB, including residing or traveling to areas of endemic TB or mycoses; monitor closely for active TB infection during tx, including patients with baseline negative latent TB screening

Mortality

higher rate of mortality, including sudden cardiovascular death, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; deuruxolitinib not approved for use in RA patients

Malignancies

malignancies observed in patients treated with deuruxolitinib; lymphoma and other malignancies observed in patients treated with JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients with known malignancy, patients who develop a malignancy during tx, or patients who are current or past smokers; periodic skin exams recommended for patients with incr. skin CA risk

Major Adverse Cardiovascular Events

higher rate of major adverse cardiovascular events, including cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients who are current or past smokers or patients with other cardiovascular risk factors; D/C deuruxolitinib in patients that experienced MI or stroke

Thrombosis

thrombosis, including DVT, PE, and cerebral venous sinus thrombosis, occurred in patients treated with deuruxolitinib; serious cases, including fatal, of DVT, PE, and arterial thrombosis reported in patients treated with other JAK inhibitors for inflammatory conditions; higher rate of thrombosis observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid deuruxolitinib in patients with thrombosis risk; D/C deuruxolitinib and promptly evaluate patients with thrombosis symptoms