Cimzia® - Ankylosing spondylitis (AS)
Cimzia® (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated in the US for the treatment of adults with active ankylosing spondylitis (AS).
Warning: serious infections and malignancy
See full prescribing information for complete boxed warning.
- Increased risk of serious infections leading to hospitalisation or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (5.1)
- Cimzia should be discontinued if a patient develops a serious infection or sepsis (5.1)
- Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia (5.1)
- Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1)
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member (5.2). Cimzia is not indicated for use in pediatric patients (8.4).
Prescribing information USA
US prescribing information
January-2023 | pdf file, 1080 kb