When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to golimumab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein or as a shot under your skin.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.
• Use a new needle and syringe each time you inject your medicine.
• 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.
• Check the liquid in the syringe or autoinjector. It should be clear and colorless or slightly yellow. Do not use Simponi® if it is cloudy, discolored, or has particles in it. Do not shake the medicine.
• 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.
• 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 abatacept, adalimumab, anakinra, certolizumab, cyclosporine, etanercept, infliximab, rituximab, theophylline, tocilizumab, medicine that weakens your immune system (such as methotrexate or steroids), or a blood thinner (such as warfarin).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have cancer, heart failure, diabetes, COPD, psoriasis, a weak immune system, Wegener granulomatosis, or active or a history of tuberculosis or hepatitis B, or any type of infection. Tell your doctor if you have a condition that affects your nervous system (such as multiple sclerosis or a history of Guillain-Barré syndrome). Tell your doctor if you are allergic to latex.
• This medicine may cause the following problems:
  
  • Higher risk of infection
  • Higher risk of lymphoma or other cancers (including skin cancer)
  • Heart failure
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• 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, and 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
• 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