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Medications and Drugs

Brand Names: Simponi, Simponi SmartJect

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

What is golimumab (Simponi, Simponi SmartJect)?

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 purposes not listed in this medication guide.

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

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.

Stop using golimumab and call your doctor right away if you have any of these symptoms of lymphoma:

  • fever, night sweats, weight loss, tiredness;
  • feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using golimumab and call your doctor at once if you have any of these other serious side effects:

  • signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);
  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up mucus or blood;
  • cold sores;
  • vision changes, neck stiffness, seizure;
  • 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 medicine.

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, Simponi SmartJect)?

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).

Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis.

Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. 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, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.

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.

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 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.

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

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



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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