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Brand Names: Simponi, Simponi SmartJect

Generic Name: golimumab (Pronunciation: goe LIM ue mab)

• What is golimumab (Simponi Injection)?
• What are the possible side effects of golimumab (Simponi Injection)?
• What is the most important information I should know about golimumab (Simponi Injection)?
• What should I discuss with my healthcare provider before using golimumab (Simponi Injection)?
• How should I use golimumab (Simponi Injection)?
• What happens if I miss a dose (Simponi Injection)?
• What happens if I overdose (Simponi Injection)?
• What should I avoid while using golimumab (Simponi Injection)?
• What other drugs will affect golimumab (Simponi Injection)?
• Where can I get more information?

What is golimumab (Simponi Injection)?

Golimumab is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.

Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab is sometimes used with another medication called methotrexate (Rheumatrex, Trexall).

Golimumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of golimumab (Simponi Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using golimumab and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• chest pain, feeling short of breath;
• cough, sore throat, coughing up bloody mucus;
• flu symptoms, stomach pain, diarrhea;
• muscle aches, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling of your ankles or feet;
• chest pain, ongoing cough, coughing up blood;
• easy bruising or bleeding, pale skin, unusual weakness;
• cold sores;
• vision changes;
• numbness or tingly feeling, weakness in your legs;
• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• dizziness; or
• redness where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about golimumab (Simponi Injection)?

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

Before using golimumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, if you have recently been vaccinated with BCG, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor about all of your medical conditions, especially if you have hepatitis, congestive heart failure, lupus, diabetes, cancer, HIV or a weak immune system, or multiple sclerosis.

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Golimumab can lower the blood cells that help your body fight infections. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, sweating, chills, tired feeling, chest pain, feeling short of breath, cough, sore throat, coughing up bloody mucus;, flu symptoms, stomach pain, diarrhea, muscle aches, or weight loss.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a "live" vaccine while you are being treated with golimumab.

Using golimumab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.