Information about Golimumab
Mechanism of action of Golimumab
Golimumab (goe lim’ ue mab) is a human monoclonal immunoglobulin antibody to tumor necrosis factor (TNF) alpha, a proinflammatory cytokine that plays a role in cell injury, inflammation and tissue damage in inflammatory, autoimmune diseases. Golimumab is one of several monoclonal antibody inhibitors of TNF and has been shown to be effective in decreasing inflammation and improving symptoms in several autoimmune diseases, including rheumatoid arthritis and ulcerative colitis.
FDA approval information for Golimumab
Golimumab was approved for use in the United States for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in 2009, and the indications were broadened to include ulcerative colitis in 2013.
Dosage and administration for Golimumab
Golimumab is available in liquid solution in single use, prefilled syringes of 50 and 100 mg under the brand name Simponi. Golimumab is given by subcutaneous injection and the regimen varies by indication. For inflammatory arthritidies the recommended dose is 50 mg once monthly. For ulcerative colitis, the recommendation is for an initial dose of 200 mg, followed by 100 mg at week 2 and then 100 mg every 4 weeks.
Side effects of Golimumab
- Common side effects include injection site reactions, chills, fever, skin rash and fatigue.
- Less common but potentially severe side effects include hypersensitivity reactions and anaphylaxis, opportunistic infections, reactivation of tuberculosis or hepatitis B, congestive heart failure, lymphoma and other malignancies and demyelinating diseases.
Liver safety of Golimumab
Golimumab has been linked to a low rate of serum enzyme elevations during therapy, but has not been linked to cases of idiosyncratic, clinically apparent liver injury with jaundice. Because golimumab is a potent inhibitor of TNF alpha, it is likely to cause reactivation of chronic hepatitis B in susceptible patients.