PREGNANCY AND BREASTFEEDING SAFETY: There are no adequate studies of golimumab in pregnant women. It is not known whether golimumab is excreted in breast milk.
STORAGE: Golimumab should be stored refrigerated at 2 C to 8 C (36 F to 46 F).
DOSING: Golimumab is injected under the skin. Injection sites should be rotated. The recommended dose is 50 mg monthly.
DRUG CLASS AND MECHANISM: Golimumab is an injectable synthetic (man-made) protein that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. As a result, the inflammation caused by these diseases and its consequences are reduced. Adalimumab (Humira), certolizumab (Cimzia) and etanercept (Enbrel) are two other injectable drugs that block TNFα. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is an protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. The unchecked inflammation of rheumatoid and psoriatic arthritis as well as ankylosing spondylitis eventually leads to destruction of the joints. Golimumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its inflammatory consequences in joints are reduced, and the progressive destruction of the joints is slowed or prevented. The FDA approved golimumab in April 2009.
Medically reviewed by Eni Williams, PharmD
REFERENCE: FDA prescribing information for Simponi
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