The FDA has approved a single-dose, disposable, autoinjection device called Otrexup (Antares Pharma) for subcutaenous methotrexate administration.
The device is indicated for adults with active, severe rheumatoid arthritis or psoriasis who have not responded to or cannot tolerate first-line therapy, and children with active polyarticular juvenile idiopathic arthritis.
Methotrexate is usually given once a week to manage these conditions, but many patients do not respond adequately or cannot tolerate the drug’s side effects, which include nausea, abdominal pan and dyspepsia, according a press release from the manufacturer.
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“The availability of an easy and safe way to administer subcutaneous methotrexate may overcome some of the current barriers to parenteral administration, which could enable more patients to realize the possibility of continued disease control and therefore benefit from subcutaneous methotrexate,” said Michael Schiff, MD, of the University of Colorado in Denver, in a press release.
The new device is not indicated for use in children with psoriasis or pregnant women. Although methotrexate is used as a cancer treatment, Otrexup is not indicated for that use.
