Otrexup

Product manufactured by Antares Pharma, Inc.

Application Nr Approved Date Route Status External Links
NDA204824 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Otrexup Is A Folate Analog Metabolic Inhibitor Indicated For The: • Management Of Patients With Severe, Active Rheumatoid Arthritis (Ra) And Polyarticular Juvenile Idiopathic Arthritis (Pjia), Who Are Intolerant Of Or Had An Inadequate Response To First-Line Therapy ( 1.1 ). • Symptomatic Control Of Severe, Recalcitrant, Disabling Psoriasis In Adults Who Are Not Adequately Responsive To Other Forms Of Therapy ( 1.2 ). Limitation Of Use Otrexup Is Not Indicated For The Treatment Of Neoplastic Diseases ( 1.3 ). 1.1 Rheumatoid Arthritis Including Polyarticular Juvenile Idiopathic Arthritis Otrexup Is Indicated In The Management Of Selected Adults With Severe, Active Rheumatoid Arthritis (Ra) (Acr Criteria), Or Children With Active Polyarticular Juvenile Idiopathic Arthritis (Pjia), Who Have Had An Insufficient Therapeutic Response To, Or Are Intolerant Of, An Adequate Trial Of First-Line Therapy Including Full Dose Non-Steroidal Anti-Inflammatory Agents (Nsaids). 1.2 Psoriasis Otrexup Is Indicated In Adults For The Symptomatic Control Of Severe, Recalcitrant, Disabling Psoriasis That Is Not Adequately Responsive To Other Forms Of Therapy, But Only When The Diagnosis Has Been Established, As By Biopsy And/or After Dermatologic Consultation. It Is Important To Ensure That A Psoriasis “flare” Is Not Due To An Undiagnosed Concomitant Disease Affecting Immune Responses. 1.3 Limitation Of Use Otrexup Is Not Indicated For The Treatment Of Neoplastic Diseases.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methotrexate METHOTREXATE ZINC1529323

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