Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Clinical Trials Experience
- section added...In two long-term (up to 7 years of exposure), open-label Crohn’s disease studies, overall 23% (207/903) of patients developed antibodies against certolizumab pegol on at least one occasion. Of the 207 patients who were antibody positive, 152 (73%) had a persistent reduction of drug plasma concentration, which represents 17% (152/903) of the study population. The data from these two studies do not suggest an association between the development of antibodies and adverse events.
WARNINGS AND PRECAUTIONS
Risk of Serious Infections
- Patients treated with Cimzia are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death…
- Patients treated with Cimzia may receive vaccinations, except for live or live attenuated vaccines. No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia…