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Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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).
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.
Otrexup is not indicated for the treatment of neoplastic diseases.
There is currently no drug history available for this drug.
Otrexup contains methotrexate, a folate analog metabolic inhibitor.
Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is:.
C20H22N8O5 M.W.= 454.45
Otrexup contains methotrexate in a sterile, preservative-free, unbuffered solution with a 27 gauge ½ inch needle for a single subcutaneous injection. Otrexup solution is yellow in color.
Inactive ingredients include sodium chloride and water for injection, USP. The amounts of sodium chloride vary with the amount of methotrexate.
Amount of methotrexate (mg) per 0.4 mL
Amount of sodium chloride (mg) per 0.4 mL
Hydrochloric acid and additional sodium hydroxide may have been added, if necessary, to adjust the pH to 8.0.