RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). RINVOQ may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
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- The most serious warnings and precautions regarding serious infections, malignancies, thrombosis and major adverse cardiovascular events.
- Other relevant warnings and precautions regarding lipid parameters; gastrointestinal perforations; hematologic events; liver enzyme elevation; hypersensitivity reactions; patients with severe hepatic impairment; concomitant use with other potent immunosuppressants, biologic DMARDs, or other Janus kinase (JAK) inhibitors; immunizations; viral reactivation, including herpes (e.g. herpes zoster) and hepatitis B; malignancies, including NMSC; increases in creatine phosphokinase; monitoring and laboratory tests; pregnant women; reproductive health; breast-feeding; geriatrics (≥65 years of age); pediatrics (<18 years of age); Asian patients.
- Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.