Zymfentra

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Consider discontinuing if significant hematologic abnormalities develop. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. Malignancies (eg, lymphoma, skin, cervical); perform periodic skin exams and routine cervical cancer screenings during treatment. Avoid use in moderate to severe COPD, history of malignancy or if malignancy develops during treatment. Monitor liver enzymes and liver function tests every 3–4 months during treatment; interrupt if drug-induced liver injury is suspected until excluded. Discontinue if lupus-like syndrome with autoantibody formation or severe hypersensitivity reactions occurs. Avoid use in congestive heart failure (CHF); closely monitor and discontinue if new or worsening symptoms occur. Avoid use in CNS demyelinating disorders (eg, multiple sclerosis, optic neuritis, Guillain-Barré syndrome); consider discontinuing if these occur. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Neonatal/infants. Pregnancy. Nursing mothers.