Pronunciation: goe LIM ue mab

Brand: Simponi

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

You should not use this medicine if you are also using abatacept or anakinra.

Serious and sometimes fatal infections may occur during treatment with golimumab, especially if you also use other medications that can weaken your immune system.

Stop using golimumab and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, stomach pain, diarrhea, muscle aches, skin redness, headache, dry cough, coughing up blood or mucus, chest discomfort, rapid heart rate, white patches in your mouth or throat, or pain when swallowing.

Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using golimumab.

What is golimumab?

Golimumab is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.

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

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

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

You should not use this medicine if you are allergic to golimumab, or if you are also using abatacept or anakinra.

Golimumab can weaken your immune system. Serious and sometimes fatal infections may occur during treatment, especially if you also use other medications that can weaken your immune system.

Using golimumab may increase your risk of certain types of cancer, including lymphoma (cancer of the lymph nodes) or melanoma (a tumor that usually affects the skin). This risk may be greater in children and young adults. You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.

Some people using this medicine have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma.

Before you start treatment with golimumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

To make sure golimumab is safe for you, tell your doctor if you have:

  • an active or recent infection (including flu symptoms, diarrhea, skin infection, bladder infection, or lung infection);
  • chronic infections that come and go;
  • hepatitis B, or other liver problem;
  • a history of cancer or lymphoma;
  • a history of congestive heart failure;
  • diabetes;
  • HIV, or a weak immune system;
  • a disease that affects the nerves or muscles, such as multiple sclerosis;
  • an allergy to latex rubber;
  • if you have ever had Guillain-Barre syndrome; or
  • if you are scheduled to receive any vaccine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. However, a newborn baby may have an increased risk of infection for up to 6 months if the mother uses golimumab during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using golimumab.

It is not known whether golimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

How should I use golimumab?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Golimumab is injected under the skin or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Golimumab comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

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

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Avoid injecting golimumab into skin that is scarred, bruised, red, tender, or hard.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store this medicine in the refrigerator but do not allow it to freeze. Keep the medication in its original carton and protect from light.

Take the prefilled syringe or autoinjector out of the refrigerator and place it at room temperature for 30 minutes before giving your injection. Do not warm the medication with water or heat.

Golimumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using golimumab.

What happens if I miss a dose?

Use the medication as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while using golimumab?

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

If you use this medication during pregnancy, your baby should not receive a live vaccine for the first 6 months after birth.

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

What are the possible side effects of golimumab?

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

Stop using golimumab and call your doctor right away if you have any of these symptoms, some of which may be signs of infection or lymphoma:

  • fever, chills, night sweats, sore throat, headache, diarrhea, muscle aches, weight loss, tiredness;
  • skin rash or redness, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate;
  • nausea, feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • dry cough, coughing up blood or mucus, chest discomfort; or
  • white patches in your mouth or throat, or pain when swallowing.

Call your doctor at once if you have any of these other side effects:

  • skin growths or changes in skin appearance;
  • shortness of breath with swelling of your ankles or feet;
  • cold sores;
  • vision changes, neck stiffness, seizure;
  • numbness or tingly feeling, weakness in your arms or legs;
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight); or
  • signs of psoriasis (raised, silvery, flaking of the skin).

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing;
  • dizziness; or
  • pain, itching, redness, or swelling where you injected the medicine.

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 medicines you use, and those you start or stop using during your treatment with golimumab, especially:

  • azathioprine;
  • mercaptopurine;
  • rituximab;
  • tocilizumab; or
  • other TNF blockers--adalimumab, certolizumab, etanercept, infliximab.

Where can I get more information?

Your 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.

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