Rheumatoid arthritis (RA): - the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate (MTX) (monotherapy or in combination with MTX). - the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumor necrosis factor (TNF) antagonists (monotherapy or in combination with MTX). Coronavirus disease 2019 (COVID-19): the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Polyarticular juvenile idiopathic arthritis (pJIA): the treatment of juvenile idiopathic polyarthritis (PJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX (monotherapy or in combination with MTX). Systemic juvenile idiopathic arthritis (sJIA): the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (monotherapy or in combination with MTX).
TYENNE — FRESENIUS KABI USA, approved 2026-05-21 (BLA761275).
237,418 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.