Golimumab (Injection)

Introduction

Golimumab (goe-LIM-ue-mab)

Treats rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This medicine is a tumor necrosis factor (TNF) blocker.

Brand Name(s)

There may be other brand names for this medicine.

Simponi

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to golimumab.

How to Use This Medicine

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
  • A nurse or other trained health professional will give you this medicine.
  • You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
  • Use a new needle and syringe each time you inject your medicine.
  • You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
  • This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
  • This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

  • If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

  • If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.
  • Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • This medicine should not be taken together with abatacept (Orencia®), adalimumab (Humira®), anakinra (Kineret®), certolizumab (Cimzia®), etanercept (Enbrel®), infliximab (Remicade®), or rituximab (Rituxan®).
  • Make sure your doctor knows if you are using medicines that weaken your immune system. These include azathioprine (Imuran®), methotrexate (Rheumatrex®, Trexall®) or a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®). Make sure your doctor knows if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), theophylline (Theo-Dur®), or a blood thinner (such as warfarin, Coumadin®).
  • Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have cancer, congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD), or any type of infection, including a history of hepatitis B or tuberculosis. Tell your doctor if you have psoriasis, problems with your immune system, or if you have multiple sclerosis or Wegener's granulomatosis.
  • You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test or been exposed to tuberculosis.
  • This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
  • Call your doctor right away if you start to have a cough, weight loss, night sweats, shortness of breath, fever, chills, unusual tiredness or weakness, or flu-like symptoms, such as a runny or stuffy nose, headache, or feeling generally ill. These may be signs that you have an infection.
  • Your risk of getting an infection increases when you travel to places where certain organisms (such as fungi, bacteria, viruses, or parasites) are more common. Tell your doctor where you live and if you have any history of travel if you start having any signs of infection.
  • Check with your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.
  • Check with your doctor right away if you have more than one of these symptoms: chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; tightness in the chest; trouble with breathing; weight gain; or wheezing. These may be signs of a heart condition called congestive heart failure (CHF).
  • Check with your doctor right away if you have more than one of these symptoms: blurred vision; difficulty controlling your bladder or bowels; difficulty with walking; feeling sad or depressed; forgetful; muscle cramps; numbness or tingling in your arms, legs, or face; slurred speech or problems with swallowing; or unusual tiredness or weakness. These may be signs of a nervous system disease called multiple sclerosis (MS).
  • The needle cover of the prefilled syringe and Smartject? autoinjector contains dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.
  • A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer, such as leukemia. Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
  • Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
  • Blistering, peeling, or red skin rash.
  • Bone pain.
  • Chest pain, slow or fast heartbeat.
  • Cold or flu symptoms such as a runny or stuffy nose, sore throat, or body aches.
  • Fever, chills, a cough that does not go away, or unexplained weight loss.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
  • Raised bumps on the skin filled with pus.
  • Red, scaly patches on the skin.
  • Shortness of breath, cold sweat, and bluish-colored skin.
  • Sores or white patches on your lips or mouth.
  • Swelling in your hands, ankles, or feet.
  • Swollen lymph nodes in the neck, underarms, or groin.
  • Troubled breathing or wheezing.
  • Unexplained weight loss.
  • Unusual bleeding, bruising, or weakness.
  • Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

  • Changes in vision.
  • Dizziness.
  • Mild skin rash.
  • Redness, itching, bruising, bleeding, pain, or swelling where the shot was given.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Review Date: 2011-02-04 Reviewed By: Keywords: ,
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