GENERIC NAME: golimumab

BRAND NAME: Simponi

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.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes P

REPARATIONS: 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