Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- In postmarketing experience, serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous and intravenous formulations of golimumab including SIMPONI ARIA. Hypersensitivity reactions including hives, pruritis, dyspnea, and nausea, were reported during infusion and generally within an hour after infusion. Some of these reactions occurred after the first administration of golimumab. If an anaphylactic or other serious allergic reaction occurs, administration of SIMPONI ARIA should be discontinued immediately and appropriate therapy instituted.
WARNINGS AND PRECAUTIONS
Malignancies in Adult Patients
- *section updated
Congestive Heart Failure
- … Some cases had a fatal outcome.
- Treatment with TNF blockers, including SIMPONI ARIA, may result in the formation of antinuclear antibodies (ANA). Rarely, treatment with TNF blockers, may result in the development of a lupus-like syndrome [see Adverse Reactions (6.1)]. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SIMPONI ARIA, treatment should be discontinued.
- *updated with information regarding leukemia, congestive heart failure, and autoimmune processes
WARNINGS AND PRECAUTIONS
5.1 Serious Infections
- Cases of active tuberculosis have occurred in patients treated with the subcutaneous formulation of golimumab 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.
5.9 Vaccinations/Therapeutic Infectious Agents
- Patients treated with SIMPONI ARIA 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 ARIA.