Cimzia Receives New Indication
May 29, 2018 – The U.S. FDA has approved a new indication for Cimzia® (certolizumab pegol), manufactured by UCB. It is now approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Recommended dosing under the new indication is two 200mg subcutaneous injections administered once every other week. For some patients whose body weight is 198lbs or less, dosing may be reduced, starting in the sixth week, to just one 200mg injection taken every other week.
Cimzia carries a black box warning that it may increase the risk of serious, potentially life-threatening infections including tuberculosis, fungal infections, and bacterial sepsis. The black box warning also indicates that lymphoma and other cancers have occurred in children and adolescents treated with TNF blockers such as Cimzia. The drug should not be prescribed to pediatric patients.
First approved in 2008, Cimzia is also indicated to treat adults who have Crohn’s disease, moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.