Application Nr Approved Date Route Status External Links
BLA125118 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Orencia Is A Selective T Cell Costimulation Modulator Indicated For: Adult Rheumatoid Arthritis (ra) (1.1) •moderately To Severely Active Ra In Adults. Orencia May Be Used As Monotherapy Or Concomitantly With Dmards Other Than Tnf Antagonists (1.1). Juvenile Idiopathic Arthritis (1.2) •moderately To Severely Active Polyarticular Juvenile Idiopathic Arthritis In Patients 2 Years Of Age And Older. Orencia May Be Used As Monotherapy Or Concomitantly With Methotrexate (1.2). Adult Psoriatic Arthritis (psa) (1.3) •active Psa In Adults. (1.3) Important Limitations Of Use ( 1.4 ) •should Not Be Given Concomitantly With Tnf Antagonists (1.4, 5.1). 1.1 Adult Rheumatoid Arthritis (ra) Orencia® Is Indicated For Reducing Signs And Symptoms, Inducing Major Clinical Response, Inhibiting The Progression Of Structural Damage, And Improving Physical Function In Adult Patients With Moderately To Severely Active Rheumatoid Arthritis. Orencia May Be Used As Monotherapy Or Concomitantly With Disease-Modifying Antirheumatic Drugs (dmards) Other Than Tumor Necrosis Factor (tnf) Antagonists. 1.2 Juvenile Idiopathic Arthritis Orencia Is Indicated For Reducing Signs And Symptoms In Patients 2 Years Of Age And Older With Moderately To Severely Active Polyarticular Juvenile Idiopathic Arthritis. Orencia May Be Used As Monotherapy Or Concomitantly With Methotrexate (mtx). 1.3 Adult Psoriatic Arthritis (psa) Orencia Is Indicated For The Treatment Of Adult Patients With Active Psoriatic Arthritis (psa). 1.4 Important Limitations Of Use Orencia Should Not Be Administered Concomitantly With Tnf Antagonists. Orencia Is Not Recommended For Use Concomitantly With Other Biologic Rheumatoid Arthritis (ra) Therapy, Such As Anakinra.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Abatacept

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