golimumab

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 a 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.

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.

• The FDA approved golimumab in April 2009.
• Simponi and Simponi Aria are the brand names for golimumab.
• Simponi and Simponi Aria are not available in generic form.
• You need a prescription for Simponi and Simponi Aria.

Common side effects include:

1. Flu
2. Elevated liver function test results
3. Fever
4. Abnormal prickling, tingling, tickling, or burning sensation (paraesthesia)

Other side effects include:

1. Injection site reactions (redness, swelling)
2. Reduced levels of blood cells
3. Reactivation of hepatitis B virus
4. New onset or worsening of psoriasis

Less common side effects include:

1. Congestive heart failure
2. Dizziness
3. Hypertension
4. Skin rash
5. Constipation

Possible serious side effects include:

1. Tuberculosis
2. Herpes infection
3. Cancer
4. Serious allergic reactions
5. Liver toxicity
6. Sepsis (bacteria in the blood)
7. Fungal infections

Individuals with active infections should not be treated with golimumab. This drug may worsen or cause new diseases of the nervous system. It also may cause or worsen congestive heart failure. In studies, some patients who used golimumab or other TNFα blocking drugs developed cancer.

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

• 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 this drug.

• There are no adequate studies of golimumab in pregnant women.
• It is not known whether this drug is excreted in breast milk.

What preparations of golimumab are available?

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

How should you keep golimumab stored?

• This drug should be stored refrigerated at 2 C to 8 C (36 F to 46 F).