Golimumab (By injection)

Golimumab (goe-LIM-ue-mab)

Treats arthritis (including rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis), ankylosing spondylitis, and ulcerative colitis.

Brand Name(s):

Simponi Aria, Simponi Autoinjector, Simponi PFS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV catheter that is placed in a vein or as a shot under your skin, usually in the stomach or thighs. Simponi Aria® must be injected slowly, so the IV will need to stay in place for 30 minutes.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Simponi® is available in 2 forms: a prefilled syringe and a SmartJect® autoinjector.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, scaly, or hard, or areas with scars or stretch marks.
• Use a new needle and syringe each time you inject your medicine.
• Simponi® SmartJect® autoinjector:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the autoinjector to warm up to room temperature. Do not warm it any other way.
  • Check the liquid in the autoinjector. It should be clear to slightly yellow and may have tiny white or clear particles. Do not use it if it is cloudy, discolored, or has large particles in it. Do not shake. Do not remove the cap until you are ready to inject.
  • Twist the cap to break the security seal then pull it straight off. Do not put the cap back on. Inject within 5 minutes of removing the cap.
  • Hold the autoinjector with one hand above the blue button and position it straight onto your skin. Make sure the green safety sleeve is stable and as flat as possible against your skin. Do not pinch your skin.
  • Push the open end of the autoinjector against your skin at a 90 degree angle. Apply enough pressure to slide the green safety sleeve up and to keep it inside the clear cover. Do not touch or press the blue button while pushing the autoinjector against your skin.
  • Keep holding the autoinjector against your skin. Use your other hand to press the raised part of the blue button to start the injection. Do not press the button until the autoinjector is pressed against your skin and the safety sleeve slides into the clear cover.
  • You will hear a loud first "click" which means the injection has started. You will hear a second "click" about 3 to 15 seconds after the first one, which means the injection is complete. Make sure you see the yellow indicator in the window.
• Simponi® prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the syringe to warm up to room temperature. Do not warm it any other way.
  • Check the liquid in the syringe. It should be clear to slightly yellow and may have tiny white or clear particles. Do not use it if it is cloudy, discolored, or has large particles in it. Do not shake. Do not use it if it has been dropped.
  • Remove the needle cover. Do not put the cover back on. Do not touch the needle.
  • Gently pinch the skin. Use a quick, dart-like motion to insert the needle into the pinched skin at a 45 degree angle.
  • Push the plunger all the way down until it stops. The safety guard will cover the needle and lock into place.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. You may also store the medicine in the original carton at room temperature for 30 days. Do not put it back in the refrigerator once you have stored it at room temperature, and throw away unused medicine after 30 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how golimumab works. Tell your doctor if you are using any of the following:
  • Abatacept, adalimumab, anakinra, certolizumab, cyclosporine, etanercept, infliximab, rituximab, theophylline, tocilizumab
  • Blood thinner (including warfarin)
  • Medicine that weakens the immune system (including a steroid or cancer medicine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should have completed any needed vaccines before starting treatment with this medicine. Tell your doctor if you have a baby and you have received this medicine while you are pregnant. Tell your child's doctor before your child receives a vaccine. This medicine may increase the risk for infections in children for up to 6 months after birth.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, cancer, heart failure, diabetes, COPD, psoriasis, problems with your immune system, granulomatosis with polyangiitis, optic neuritis, multiple sclerosis, or a history of Guillain-Barré syndrome. Tell your doctor if you have any type of infection (including hepatitis B or tuberculosis) or an infection that keeps coming back. Also, tell your doctor if you are allergic to latex.
• This medicine may cause the following problems:
  • Increased risk for serious infections
  • Increased risk of certain cancers (including lymphoma, leukemia, colon cancer, skin cancer)
  • Heart problems, including heart failure
  • Liver problems
  • Lupus-like syndrome
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, painful urination
• Changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Swollen glands in the neck, underarms, or groin
• Trouble breathing, chest pain, uneven heartbeat
• Unusual bleeding, bruising, or weakness
• Warm, red, swollen, or painful skin, blisters, skin sores

If you notice these less serious side effects, talk with your doctor:

• Redness, itching, pain, or swelling where the needle was placed or the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 12/4/2025