Cimzia® - Rheumatoid arthritis (RA)

Europe

In Europe, Cimzia®, in combination with methotrexate (MTX), is indicated for

• the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

• the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
 

USA

Cimzia® (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated in the US for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

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).

Related website

• Cimzia® product website (for US residents only)