golimumab, Simponi (cont.)

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PREPARATIONS: Injection (Prefilled Syringe): 50 mg/0.5 ml

STORAGE: Golimumab should be stored refrigerated at 2 to 8 C (36 to 46 F).

PRESCRIBED FOR: Golimumab is used in combination with methotrexate (Rheumatrex, Trexall) for treating rheumatoid arthritis and alone or combined with methotrexate for treating psoriatic arthritis. It also is used for treating ankylosing spondylitis.

DOSING: Golimumab is injected under the skin. Injection sites should be rotated. The recommended dose is 50 mg monthly.

DRUG INTERACTIONS: Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) with golimumab may result in a reduction of white blood cells in the blood (neutropenia), serious infections and no additional benefit. Golimumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be given to patients receiving golimumab.

PREGNANCY: There are no adequate studies of golimumab in pregnant women.

NURSING MOTHERS: It is not known whether golimumab is excreted in breast milk.

SIDE EFFECTS: The most common adverse effects in clinical studies of golimumab were respiratory tract infections and elevations in liver tests suggesting injury to the liver. Injection site reactions (redness, swelling) may also occur. Like other drugs that block TNFα, use of golimumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with golimumab. Golimumab may worsen or cause new diseases of the nervous system. Golimumab also may cause or worsen congestive heart failure. In studies, some patients who used golimumab or other TNFα blocking drugs developed cancer. Other side effects include reduced levels of blood cells, reactivation of hepatitis B virus in chronic careers of the virus and new onset or worsening of psoriasis.

REFERENCE: FDA prescribing information for Simponi

Last Editorial Review: 9/10/2010 1:10:26 PM

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