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New Cimzia® (certolizumab pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations With Active Rheumatoid Arthritis (RA)
Date:11/9/2010

rt FailureCases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.  Certolizumab pegol has not been formally studied in patients with CHF.  Exercise caution when using certolizumab pegol in patients who have heart failure and monitor them carefully.

HypersensitivitySymptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following certolizumab pegol administration.  If such reactions occur, discontinue further administration of certolizumab pegol and institute appropriate therapy.

Hepatitis B ReactivationUse of TNF blockers, including certolizumab pegol, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating certolizumab pegol therapy.  Exercise caution in prescribing certolizumab pegol for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue certolizumab pegol and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic ReactionsUse of TNF blockers, including certolizumab pegol, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with certolizumab pegol. Exercise caution in considering the use of certolizumab pegol in patients with the
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1. Rapid and Long-term Clinical Responses Observed in Rheumatoid Arthritis Patients Taking Cimzia® (certolizumab pegol), According to Data Being Highlighted During ACR Meeting
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8. CIMZIA(R) (certolizumab pegol), Significantly Reduces Structural Damage and Rheumatoid Arthritis Signs & Symptoms for Up to One Year
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