New Strengths for Otrexup
March 24, 2016 – The U.S. Food and Drug Administration (FDA) approved three additional strengths of Otrexup™ (methotrexate) injection manufactured by Antares Pharma. Otrexup is used to treat adults who did not respond to previous therapy for rheumatoid arthritis or psoriasis. Otrexup also is indicated as second-line treatment for children who have polyarticular juvenile idiopathic arthritis. Otrexup is now available in eight strengths ranging from 7.5mg to 25mg in 2.5mg increments, and is packaged in single-use auto-injectors containing the appropriate dose. Consistent with labeling for all methotrexate products, the labeling Otrexup carries a boxed warning about the risks of serious, sometimes fatal, organ damage and other severe adverse events that can occur with its use.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.