Cimzia® - Crohn's disease
USA
Cimzia® (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated in the US for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
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).
Switzerland
In Switzerland, Cimzia® is indicated for the induction of a clinical response and for the maintenance of a clinical response and remission in patients with active Crohn's disease who have not responded adequately to conventional treatment.
Prescribing information USA
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US prescribing information
January-2023 | pdf file, 1080 kb