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 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.

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

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.

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. You may be able to give this injection to yourself.

Your healthcare provider will show you where to inject golimumab. Do not inject into the same place two times in a row.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

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

Throw away a prefilled syringe or auto-injector after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep 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?

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).

What are the possible side effects of golimumab?

• 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.

• 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.

What other drugs will affect golimumab?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

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 doctor or pharmacist can provide more information about golimumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 8.01. Revision date: 6/6/2023.