What is Otrexup?
Otrexup is a single-use, prefilled auto-injector that delivers methotrexate, a prescription drug used to treat adults with severe active rheumatoid arthritis (RA) and children with active polyarticular juvenile idiopathic arthritis (pJIA). It provides subcutaneous injections at home, with doses from 7.5 mg to 25 mg.[1]
How does Otrexup work?
Methotrexate in Otrexup suppresses the immune system to reduce inflammation in RA and pJIA. The auto-injector needle automatically deploys and retracts, allowing self-administration in the thigh or abdomen. It uses voice-guided instructions and beeps to confirm delivery.[1]
Who makes Otrexup and when was it approved?
Antares Pharma developed Otrexup, which the FDA approved in October 2013 for RA and later expanded to pJIA. It's now marketed by Teva Pharmaceuticals after acquiring Antares in 2021.[1][2]
Common uses beyond arthritis
Doctors also prescribe Otrexup off-label for psoriasis and certain cancers, though it's FDA-approved only for RA and pJIA.[1]
How does it compare to other methotrexate options?
Unlike oral methotrexate tablets, Otrexup offers better absorption and tolerability for patients with nausea. It competes with other injectables like Rasuvo (similar auto-injector) and generic methotrexate syringes. Otrexup's needle-free design after injection reduces needle-stick fears.[1][3]
Dosage and administration details
Administer weekly. Adults start at 7.5 mg; max 25 mg. Shake gently before use; store at room temperature. It holds six strengths in color-coded devices.[1]
What side effects do patients report?
Common issues include nausea, fatigue, mouth sores, and hair thinning. Serious risks: liver damage, lung problems, infections, or birth defects—avoid during pregnancy. Requires blood tests for monitoring.[1]
Pricing and access
A single 25 mg dose costs $500-$700 without insurance; copay cards lower it to $5-$25 for eligible patients. Medicare covers it with prior authorization.[3]
Patent status and generics
Otrexup's device patents, held by Antares Pharma, expire around 2027-2030. Check DrugPatentWatch.com for updates on challenges or generic entry.[4]
[1] FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5027lbl.pdf
[2] Antares Pharma press release: https://www.tevausa.com/news-and-media/press-releases/teva-completes-acquisition-of-antares-pharma/
[3] GoodRx: https://www.goodrx.com/otrexup
[4] DrugPatentWatch.com: https://www.drugpatentwatch.com/p/tradename/OTREXUP