Golimumab is used to treat rheumatoid arthritis and ankylosing spondylitis in adults.

Golimumab is also used alone or in combination with other medicines to treat psoriatic arthritis and polyarticular juvenile idiopathic arthritis in adults and children at least 2 years old.

Golimumab is also used alone or in combination with other medicines to treat ulcerative colitis in adults when other medicines have not worked or could not be tolerated.

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

You should not use golimumab if you are allergic to rubber or latex.

Tell your doctor if you have or ever had:

• an active or chronic infection;
• a nerve-muscle disorder such as multiple sclerosis or Guillain-Barré syndrome;
• cancer or lymphoma;
• congestive heart failure;
• psoriasis; or
• recently received or scheduled to receive a live vaccine.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Using golimumab may increase your risk of developing other cancers. Ask your doctor about this risk.

It is not known if golimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your baby's doctor if you used golimumab during pregnancy. It could affect your baby's vaccination schedule during the first 6 months of life.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Simponi Smartject (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, muscle aches, feeling very tired;
• cough, bloody mucus, shortness of breath;
• weight loss;
• painful skin sores, warmth, or redness;
• diarrhea, stomach pain; or
• increased urination, or burning when you urinate.

Also call your doctor at once if you have:

• skin growths or changes in skin appearance;
• swelling in your lower legs;
• vision changes;
• numbness or tingly feeling, weakness in your arms or legs;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or
• signs of psoriasis--red or scaly patches of skin, flaking, pus.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• abnormal liver function tests;
• high blood pressure;
• skin rash;
• low blood cell counts; or
• pain, itching, redness, bruising, tingling or swelling where the medicine was injected.

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.

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).