Golimumab (goe-LIM-ue-mab)

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

Brand Name(s):

Simponi, Simponi Aria

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 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. Do not inject into skin areas that are red, bruised, tender, or hard, or have scars or stretch marks.
• 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. You may also store the medicine in the original carton at room temperature for 30 days, as needed. Do not put it back in the refrigerator once you have stored it at room temperature, and throw it away after 30 days.

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. 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.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• 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