FDA revises golimumab label

The FDA has released changes to the warnings and precautions section of the label for golimumab, to reflect key safety concepts with that of similar warnings for other tumor necrosis factor-alpha inhibitors.

The labeling includes details related to the incidence of lymphoma and leukemia among patients in controlled portions of clinical trials of golimumab (Simponi, Simponi Aria; Janssen) which is similar to an increased incidence observed in clinical trials with other tumor necrosis factor (TNF) alpha inhibitors. However, the warning also states patients with RA and other inflammatory diseases may have a higher risk for lymphoma and leukemia in the absence of TNF inhibitors, and that most patients who developed lymphoma received azathioprine or 9-mercaptopurine. According to a Janssen representative, the updates were not triggered by new safety data.

A warning for an increased risk for worsening or new-onset congestive heart failure (CHF) and a recommendation to monitor patients with CHF and use caution when prescribing TNF inhibitors for those patients was included. A risk for the formation of anti-nuclear antibodies related to a lupus-like syndrome in patients who received TNF inhibitors was also reported in the label revision.

Golimumab is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis.

Reference:

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory

Editor’s note: This story was updated after initial publication with additional information from Janssen.