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Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease
Date:5/20/2008

ptic neuritis, and peripheral neuropathy have been reported in patients treated with Cimzia(R); the causal relationship to Cimzia(R) remains unclear. Exercise caution in considering the use of Cimzia(R) in patients with these disorders.

Rare 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 Cimzia(R). The causal relationship of these events to Cimzia(R) remains unclear. 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 Cimzia(R). Consider discontinuation of Cimzia(R) therapy in patients with confirmed significant hematologic abnormalities.

Serious infections were seen in clinical studies with concurrent use of anakinra (an interleukin-1 antagonist) and another TNF blocker, with no added benefit. Therefore, the combination of Cimzia(R) and anakinra is not recommended.

Interference with certain coagulation assays has been detected in patients treated with Cimzia(R). There is no evidence that Cimzia(R) therapy has an effect on in vivo coagulation.

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

Treatment with Cimzia(R) 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.

Do not administer live vaccines or attenuated vaccines concurrently with Cimzia(R). In controlled Crohn's clinical trials, the most common adverse events that occurred in greater than or equal to 5% of Cimzia(R) patients (n=620)
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