Humira Approved for Panuveitis Treatment
June 30, 2016 –The U.S. FDA approved Humira® (adalimumab), manufactured by AbbVie, with an expanded indication for the treatment of non-infectious intermediate, posterior and panuveitis. The FDA granted Humira orphan drug designation for this indication to treat Uveitis which is an inflammatory eye disease that can flare and impact vision, typically treated with corticosteroids. Recommended dosing of Humira for uveitis is 80mg, followed by 40mg every other week by subcutaneous injection. Humira is also indicated to treat nine other inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease (in adults and children), ulcerative colitis, psoriasis and hidradenitis suppurativa.
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-FDA-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.