Serious infections leading to hospitalization or death including TB, bacterial sepsis, invasive fungal, and other opportunistic infections have occurred in patients receiving golimumab (should be discontinued if a patient develops a serious infection or sepsis; perform test for latent TB; if positive, start treatment for TB prior to starting golimumab therapy; monitor all patients for active TB during treatment, even if initial latent TB test is negative). Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers. Invasive fungal infections have occurred (for those patients who reside in or travel to regions where mycoses are endemic, consider empiric antifungal therapy if they develop a serious systemic illness). Hepatitis B reactivation (monitor HBV carriers during and several months after therapy. If reactivation occurs, stop golimumab treatment and begin anti-viral therapy). Cases of worsening heart failure or new onset may occur (stop treatment if new or worsening symptoms occur). Demyelinating disease, exacerbation or new onset, may occur. There have been post-marketing reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF-blockers. Patients treated with golimumab may receive vaccinations, except for live vaccines. A patient who requires surgery while on golimumab should be closely monitored for infections, and appropriate actions should be taken. The relative deficiency of TNF caused by anti-TNF therapy may result in the initiation of an autoimmune process.