Litfulo

Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious infections. Chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to initiation. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection develops. Screen for viral hepatitis per clinical guidelines before starting therapy. In rheumatoid arthritis patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). Perform periodic skin exam in those with skin cancer risk. Monitor CBCs and hepatic function at baseline, during, and thereafter as clinically indicated. Avoid initiation or interrupt therapy if ALC <500/mm³ or platelets <100000/mm³. Interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Update immunizations based on current guidelines prior to initiation. Discontinue and evaluate if a serious hypersensitivity reaction occurs. Severe hepatic impairment: not recommended.  Elderly. Pregnancy. Nursing mothers: not recommended (during and for ~14 days after the last dose).