These are people who have saved lives and whose lives were in danger. Additional adverse events include vascular disorders, central nervous system disorders, and gastrointestinal disorders Table 3. Golimumab was approved with a boxed warning about serious infections and malignancy. Therapy with golimumab should not be started during an active infection.
If an infection develops, the patient should be monitored carefully and golimumab treatment should be stopped if the infection becomes serious. Patients should be tested for latent TB before the initiation of golimumab therapy. If the TB test is positive, treatment should be started for TB before initiating therapy with golimumab. Patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.
For patients who develop a systemic illness while taking golimumab, empiric antifungal therapy should be considered for those who live in or travel to regions where mycoses are endemic. Hepatitis B virus carriers should be monitored during and several months after therapy with golimumab. If reactivation occurs, treatment with golimumab should be discontinued and antiviral therapy should be initiated. The incidence of lymphoma was greater than in the general US population.
Cases of other malignancies have been observed among patients receiving TNF blockers. The worsening or new onset of heart failure may occur with golimumab.
If worsening symptoms occur, the use of golimumab should be stopped. The exacerbation or new onset of demyelinating diseases may occur with golimumab. Serious systemic hypersensitivity reactions, including anaphylaxis, may occur with golimumab. Live vaccines should not be given concurrently with golimumab. There are no adequate and well-controlled trials of golimumab in pregnant women. Golimumab should be used during pregnancy only if clearly needed.
