golimumab (Simponi, Simponi Aria, Simponi SmartJect)

Brand Names: Simponi, Simponi Aria, Simponi SmartJect

Generic Name: golimumab

• What is golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• What are the possible side effects of golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• What is the most important information I should know about golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• What should I discuss with my healthcare provider before using golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• How should I use golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• What happens if I miss a dose (Simponi, Simponi Aria, Simponi SmartJect)?
• What happens if I overdose (Simponi, Simponi Aria, Simponi SmartJect)?
• What should I avoid while using golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• What other drugs will affect golimumab (Simponi, Simponi Aria, Simponi SmartJect)?
• Where can I get more information (Simponi, Simponi Aria, Simponi SmartJect)?

Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis. Golimumab is sometimes used with another medicine called methotrexate (Rheumatrex, Trexall).

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

Get emergency medical help if you have signs of an allergic reaction: hives, itching; nausea; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat, mouth sores, feeling light-headed;
• cough, shortness of breath;
• night sweats, loss of appetite, weight loss, and feeling very tired;
• skin sores, warmth, or redness;
• diarrhea, stomach pain, coughing up blood; or
• increased urination, or burning when you urinate.

Also call your doctor at once if you have:

• skin growths or changes in skin appearance;
• shortness of breath with swelling of your ankles or feet;
• 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.

Golimumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start using golimumab.

You should not use golimumab if you are allergic to it.

Tell your doctor if you have ever had:

• active or chronic infections;
• hepatitis B (or if you are a carrier of the virus);
• diabetes;
• skin cancer (or a family history);
• HIV, or a weak immune system;
• a nerve-muscle disease such as multiple sclerosis or Guillain-Barré syndrome;
• cancer or lymphoma;
• congestive heart failure;
• an allergy to latex rubber;
• 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.

Golimumab may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

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 baby should not receive a live vaccine for the first 6 months after birth.

You should not breastfeed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

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

If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start using golimumab.

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. Use a different place each time you give an injection. 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.

Store the medication in its original carton in the refrigerator, do not freeze. Protect from light.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the medication with water or heat.

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.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using golimumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

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.

Your pharmacist can provide more information about golimumab.

Copyright 1996-2019 Cerner Multum, Inc.