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Label Changes for:

Simponi (Golimumab) Injection

November 2013

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 2013

WARNINGS AND PRECAUTIONS

Tuberculosis
  • Cases of active tuberculosis have occurred in patients treated with SIMPONI during and after treatment for latent tuberculosis. Monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.
Vaccinations/Therapeutic Infectious Agents
  • Live Vaccines - Patients treated with Simponi may receive vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to live vaccination, or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections.
  • Therapeutic Infectious Agents - Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with Simponi.

ADVERSE REACTIONS

Post-marketing Experience
  • Respiratory, thoracic and mediastinal disorders: Interstitial lung disease
  • Skin and subcutaneous tissue disorders: Skin exfoliation, rash

 

 

April 2013

 

WARNINGS AND PRECAUTIONS

Malignancies
  • Melanoma has been reported in patients treated with TNF-blocking agents, including Simponi. Merkel cell carcinoma has been reported in patients treated with TNF-blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

 

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