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Golimumab (goe LIM ue mab)

Brand Names: U.S.

Simponi; Simponi Aria

Brand Names: Canada

Simponi; Simponi I.V.

Warning

  • Very bad and sometimes deadly infections have happened in patients who take this drug. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
  • TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.
  • Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.

What is this drug used for?

  • It is used to treat rheumatoid arthritis.
  • It is used to treat ankylosing spondylitis.
  • It is used to treat psoriatic arthritis.
  • It is used to treat ulcerative colitis.

What do I need to tell my doctor BEFORE I take this drug?

  • If you have an allergy to golimumab, polysorbate 80, or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have an infection.
  • If you are taking any of these drugs: Abatacept, adalimumab, anakinra, certolizumab, etanercept, infliximab, rituximab, or tocilizumab.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

All products:

  • Tell dentists, surgeons, and other doctors that you use this drug.
  • Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
  • Talk with your doctor before getting any vaccines. Use with this drug may either raise the chance of an infection or make the vaccine not work as well.
  • Have your blood work checked often. Talk with your doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Do not give to a child younger than 18 years of age.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Shot (if given into the fatty part of the skin):

  • If you have a latex allergy, talk with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of lupus like a rash on your cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Feeling very tired or weak.
  • A burning, numbness, or tingling feeling that is not normal.
  • Change in eyesight.
  • Swollen gland.
  • Night sweats.
  • A big weight loss.
  • Any bruising or bleeding.
  • Pale skin.
  • Very bad headache.
  • Shortness of breath, a big weight gain, swelling in the arms or legs.
  • Red scaly patches or bumps that are pus filled.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read and follow the dosing on the label closely.

Shot (if given in the vein):

  • It is given as a shot into a vein over a period of time.

Shot (if given into the fatty part of the skin):

  • It is given as a shot into the fatty part of the skin.
  • Your doctor may teach you how to give the shot.
  • Follow how to give closely if you or a family member is giving the shot at home.
  • Do not shake the solution.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not give into red or irritated skin.
  • Wash your hands before and after use.
  • Move the site where you give the shot with each shot.
  • Throw syringe away after use. Do not use more than one time.
  • Throw away needles in a needle/sharp disposal box. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

Shot (if given into the fatty part of the skin):

  • Take a missed dose as soon as you think about it.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

Shot (if given in the vein):

  • Call your doctor to find out what to do.

How do I store and/or throw out this drug?

Shot (if given into the fatty part of the skin):

  • Store in a refrigerator. Do not freeze.
  • Protect from light.

Shot (if given in the vein):

  • This drug will be given to you in a hospital or doctor’s office. You will not store it at home.

All products:

  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

General drug facts

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

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