golimumab

golimumab

Pronunciation: goe LIM ue mab

Brand: Simponi, Simponi SmartJect

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

Multum donot

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

Multum emt

Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using golimumab or similar medicines to treat Crohn's disease or ulcerative colitis.

Multum donot

Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Multum emt

Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.

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.

Tell your doctor about all of your medical conditions, especially if you have hepatitis, congestive heart failure, lupus, diabetes, cancer, HIV or a weak immune system, or multiple sclerosis.

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

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Do not receive a "live" vaccine while you are being treated with 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, and ankylosing spondylitis. 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?

Multum donot

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

Multum emt

Some people using golimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults 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. Talk to your doctor about your individual risk.

Before using 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.

Multum donot

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 you can safely use golimumab, tell your doctor if you have any of these other conditions:

  • an active or recent infection;
  • hepatitis B;
  • congestive heart failure;
  • lupus;
  • diabetes;
  • cancer, HIV, or a weak immune system;
  • an allergy to latex rubber;
  • a disease that affects the nerves or muscles, such as multiple sclerosis;
  • if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
  • if you are scheduled to receive any vaccines.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Multum nobrfeed

It is not known whether golimumab passes into breast milk. Do not use golimumab without first talking to your doctor if you are breast-feeding a baby.

How should I use golimumab?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Golimumab is usually given once per month. Follow the directions on your prescription label.

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

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Golimumab is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Multum donot

Do not shake the golimumab prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors, is cloudy, or has any particles in it. Call your doctor for a new prescription.

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 pre-filled syringe of golimumab is for one use only. Throw away the auto-injector after one use, even if there is still some medicine left in it after injecting your dose.

Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.

Multum emt

Golimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, or muscle aches.

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. Visit your doctor regularly.

Multum refig

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

Multum rt

You may 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.

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?

Multum emt

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

What should I avoid while using golimumab?

Multum donot

Do not receive a "live" vaccine while you are being treated with golimumab.

What are the possible side effects of golimumab?

Multum emt

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.

Multum donot

Stop using golimumab and call your doctor right away if you have any of these symptoms of lymphoma:

  • fever, night sweats, weight loss, tiredness;
  • feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Multum donot

Stop using golimumab and call your doctor at once if you have any of these other serious side effects:

  • signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);
  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up mucus or blood;
  • cold sores;
  • vision changes, neck stiffness, seizure;
  • numbness or tingly feeling, weakness in your legs;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • dizziness; or
  • redness 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 other medications you use, especially:

  • abatacept (Orencia);
  • anakinra (Kineret);
  • rituximab (Rituxan);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • theophylline (Elixophyllin, Theo-24, Uniphyl);
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or
  • a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quin-G).

This list is not complete and other drugs may interact with golimumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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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