Simponi Warnings

Infections: Serious infections leading to hospitalization or death, including sepsis, tuberculosis (TB), invasive fungal, and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI. Administration of SIMPONI should be discontinued if a patient develops a serious infection or sepsis. Treatment with SIMPONI should not be initiated in patients with active infections including chronic or localized infections (see Precautions).
Physicians should exercise caution when considering the use of SIMPONI in patients with a history of recurring or latent infections, including TB, or with underlying conditions, which may predispose patients to infections, who have resided in regions where TB and invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including SIMPONI. Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection.
Before starting treatment with SIMPONI, all patients should be evaluated for both active and latent tuberculosis.
If latent tuberculosis is diagnosed, treatment for latent tuberculosis should be started with anti-tuberculosis therapy before initiation of SIMPONI.
Physicians should monitor patients receiving SIMPONI for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, of which SIMPONI is a member.