golimumab

What is the most important information I should know about golimumab?

What is golimumab?

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

Golimumab is also used to treat psoriatic arthritis and polyarticular juvenile idiopathic arthritis in adults and children at least 2 years old.

Golimumab is also used to treat ulcerative colitis (UC) in adults when other medicines have not worked or could not be tolerated.

Golimumab is sometimes given with methotrexate or a steroid medicine.

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

What should I discuss with my healthcare provider before using golimumab?

Tell your doctor if you have ever had:

• active or chronic infections;
• a nerve-muscle disease such as multiple sclerosis or Guillain-Barré syndrome;
• cancer or lymphoma;
• congestive heart failure;
• psoriasis; or
• if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal 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 autoimmune disorders or cancer, including skin cancer. Talk to your doctor about this risk and what symptoms to watch for.

Tell your doctor if you are pregnant or plan to become pregnant. Your baby could have an increased risk of infection for up to 6 months if you use golimumab during pregnancy. If you use golimumab during pregnancy, your newborn baby should not receive a live vaccine for at least 6 months after you last received a dose of golimumab.

How should I use golimumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Golimumab is sometimes given as an infusion into a vein. A healthcare provider will give you this type of injection once every 4 to 8 weeks.

Golimumab may also be injected under the skin once every 2 to 4 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you the best places on your body to inject golimumab. Do not inject into the same place two times in a row.

Golimumab can weaken your immune system. Your blood will need to be tested often.

Each single-use prefilled syringe or auto-injector device is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using golimumab?

Do not receive a "live" vaccine while using golimumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of golimumab?

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

• skin growths or changes in skin appearance;
• swelling in your lower legs;
• vision changes;
• numbness or tingly feeling, weakness in your arms or legs;
• pale skin, easy bruising or bleeding;
• liver problems --right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• new or worsening symptoms of lupus --muscle or 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:

• infections, cold or flu symptoms;
• abnormal liver function tests;
• high blood pressure;
• rash; or
• pain, itching, redness, 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.

What other drugs will affect golimumab?

Tell your doctor about all your other medicines, especially:

• anakinra;
• abatacept, etanercept; or
• adalimumab, certolizumab, infliximab, rituximab, or tocilizumab.

This list is not complete. Other drugs may affect golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about golimumab.