Label Changes for:

Cimzia (certolizumab pegol)

November 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2012

WARNINGS AND PRECAUTIONS

Malignancies
  • Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer

ADVERSE REACTIONS

Postmarketing Experience
  • Immune System Disorders: sarcoidosis 

 

 

October 2012

 

WARNINGS AND PRECAUTIONS

Hepatitis B Virus Reactivation
  • Use of TNF blockers, including Cimzia, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. The majority of reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation.
  • Test patients for HBV infection before initiating treatment with Cimzia. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require treatment with Cimzia should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.
  • In patients who develop HBV reactivation, discontinue Cimzia and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of Cimzia therapy in this situation and monitor patients closely.

 

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