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Simponi

Generic Name: Golimumab (goe LIM ue mab)
Brand Name: Simponi

Warning

  • Very bad and sometimes deadly infections have happened in patients who take Simponi (golimumab). 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 medicine. 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 Simponi.
  • Lymphoma and other cancers have happened in people who take this medicine or drugs like it. This has been deadly in some cases. Talk with the doctor.

Uses of Simponi:

  • 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.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Simponi?

  • If you have an allergy to golimumab, polysorbate 80, or any other part of Simponi.
  • 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 medicine.

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 Simponi 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 Simponi?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have had hepatitis B before or carry the virus, Simponi can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems. You will be tested for hepatitis B before starting this medicine. You will need to watch for signs of hepatitis while taking Simponi and for several months after stopping it. Talk with your doctor.
  • Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
  • Do not get a weakened bacteria like BCG for bladder cancer while you use Simponi. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
  • Allergic reactions have happened with this medicine. Some reactions may be very bad or life-threatening. When allergic reactions have happened with infusions of Simponi (golimumab), most of the time they have happened during the infusion or within 1 hour after the infusion. Call your doctor right away if you have any signs that are not normal.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
  • If you are 65 or older, use Simponi with care. You could have more side effects.
  • This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
  • If you have a latex allergy, talk with your doctor.
  • 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 medicine while you are pregnant.
  • If you used Simponi when you were pregnant, tell your baby's doctor. Your baby may have a higher chance of getting an infection for at least 6 months after birth. Your baby's doctor will also need to decide when your baby is to get any vaccines. Certain vaccines may cause infections that can lead to very bad health problems or death if given within 6 months after birth.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Simponi) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Before using Simponi, take it out of the refrigerator and leave it at room temperature for 30 minutes.
  • Do not heat or microwave.
  • Do not shake the solution.
  • This medicine is colorless to a faint yellow. Do not use if the solution changes color.
  • 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.
  • If your dose is more than 1 injection, give the injections into 2 different places.
  • Throw syringe away after use. Do not use the same syringe more than one time.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. 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?

  • 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.

Dosage Information (comprehensive)

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 like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • 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 the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure.
  • Feeling very tired or weak.
  • Swollen gland.
  • Night sweats.
  • A big weight loss.
  • Any unexplained bruising or bleeding.
  • Pale skin.
  • Red scaly patches or bumps that are pus filled.
  • A skin lump or growth.
  • Heart failure has happened with this medicine, as well as heart failure that has gotten worse in people who already have it. Sometimes, this has been deadly. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
  • Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.

What are some other side effects of Simponi?

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 Simponi 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 the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

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.

How do I store and/or throw out Simponi?

  • Store in a refrigerator. Do not freeze.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • 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.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Simponi, please talk with the doctor, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Simponi. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Simponi (golimumab).

Review Date: December 6, 2017

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