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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

se disorders.

Hematologic ReactionsRare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with certolizumab pegol.  Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on certolizumab pegol.  Consider discontinuation of certolizumab pegol therapy in patients with confirmed significant hematologic abnormalities.

Drug InteractionsAn increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept.  Formal drug interaction studies have not been performed with rituximab or natalizumab; however because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of certolizumab pegol in these combinations.  Therefore, the combination of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended.  Interference with certain coagulation assays has been detected in patients treated with certolizumab pegol.  There is no evidence that certolizumab pegol therapy has an effect on in vivo coagulation.  Certolizumab pegol may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

AutoimmunityTreatment with certolizumab pegol may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome.  Discontinue treatment if symptoms of lupus-like syndrome develop.

ImmunizationsDo not administer live vaccines or attenuated vaccines concurrently with certolizumab pegol.

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