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Cimzia® (certolizumab pegol) Data Showed Rapid Improvement in Signs and Symptoms Predicted Better Long-Term Outcomes in Rheumatoid Arthritis Patients
Date:5/10/2011

s.  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.

Hypersensitivity

Symptoms 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 Reactivation

Use 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 Reactions

Use of TNF blockers, including CIMZIA, 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 CIMZIA. Exercise caution in considering the use of CIMZIA in patients with these disorders.

Hematologic Reactions

Rare reports of pancytopenia, includi
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1. Cimzia® (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
2. New Cimzia® (certolizumab pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations With Active Rheumatoid Arthritis (RA)
3. 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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