Gadolinium

These are the three types of Gadolinium we use.

PROHANCE®

(prō-ˈhan(t)s)
(Gadoteridol)
Injection for intravenous use

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

  • PROHANCE is a medicine that will be given to you for your magnetic resonance imaging (MRI) procedure.
  • PROHANCE contains a “heavy metal” called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
  • There are no known harmful effects from gadolinium staying in the body in patients with normal kidneys. More studies on the safety of gadolinium are underway.
  • The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
  • Some people can feel pains, tiredness, and skin, muscle or bone ailments for a long time. These conditions have not been directly linked to gadolinium.
  • People who get many doses of gadolinium, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
  • Some people with kidney problems who get gadolinium can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive PROHANCE.

What is PROHANCE?

PROHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA). PROHANCE is used with a magnetic resonance imaging (MRI) scanner to see problems in your body.

Do not receive PROHANCE if you have had a severe allergic reaction to GBCAs including gadoteridol, or any of the ingredients in PROHANCE.

Before receiving PROHANCE, tell your healthcare provider about all your medical conditions, including if you:

  • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
  • are pregnant or plan to become pregnant. It is not known if PROHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as PROHANCE is received during pregnancy
  • have kidney problems
  • have diabetes
  • have high blood pressure
  • have had an allergic reaction to dyes (contrast agents) including

What are the possible side effects of PROHANCE?

  • See “What is the most important information I should know about PROHANCE?”
  • Allergic reactions. PROHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.
  • The most common side effects of PROHANCE include: nausea, headache, pain, cold feeling, or burning at the injection site, and rash.
    These are not all the possible side effects of PROHANCE.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    General information about the safe and effective use of PROHANCE.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about PROHANCE that is written for health professionals.

    What are the ingredients in PROHANCE?
    This Patient Information or Medication Guide has been approved by the U.S. Food and Drug Administration
    Inactive ingredients: calteridol calcium, tromethamine
    Manufactured by: BIPSO GmbH-78224 Singen (Germany)
    Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831
    US Patent No. 5,474,756; 5,846,519; and 6,143,274.
    For more information, go to www.imaging.bracco.com or call 1-800-257-5181.
    This Patient Information or Medication Guide has been approved by the U.S. Food and Drug Administration | Issued: 1/2018
    COEB501

    Download PDF


    EOVIST

    (e-o-vist)
    (gadoxetate disodium)
    Injection for intravenous use

    What is Eovist?

    • Eovist is a prescription medicine called a gadolinium-based contrast agent (GBCA). Eovist, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
    • An MRI exam with a GBCA, including Eovist, helps your doctor to see problems better than an MRI exam without a GBCA. Eovist is needed to better see the problems in your liver.
    • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.

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

    • Eovist contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
    • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
    • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
    • At equivalent doses, the amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance.
      Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
    • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
    • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive Eovist.

    Do not receive Eovist if you have had a severe allergic reaction to Eovist, Before receiving Eovist, tell your healthcare provider about all your medical conditions, including if you:

    • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
    • are pregnant or plan to become pregnant. It is not known if Eovist can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as Eovist is received during pregnancy.
    • have kidney problems, diabetes, or high blood pressure.
    • have had an allergic reaction to dyes (contrast agents) including GBCAs

    What are the possible side effects of Eovist?

    • See “What is the most important information I should know about Eovist?”
    • Allergic reactions. Eovist can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.

    The most common side effects of Eovist include: nausea, headache, feeling hot, dizziness, and back pain. These are not all the possible side effects of Eovist.

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

    General information about the safe and effective use of EOVIST.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about EOVIST that is written for health professionals.

    What are the ingredients in Eovist?
    Active ingredient: gadoxetate disodium
    Inactive ingredients: caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection.
    Manufactured for Bayer HealthCare Pharmaceuticals Inc.

    Manufactured in Germany
    © 2008 Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
    For more information, go to www.eovist.com or call 1-888-842-2937.
    This Medication Guide has been approved by the U.S. Food and Drug Administration 4/2018
    Reference ID: 4254305

    Download PDF


    MEDICATION GUIDE MULTIHANCE®

    (məl-tē-han(t)s)
    (gadobenate dimeglumine)
    Injection for intravenous use

    What is MULTIHANCE?

    • MULTIHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA). MULTIHANCE, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
    • An MRI exam with a GBCA, including MULTIHANCE, helps your doctor to see problems better than an MRI exam without a GBCA.
    • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.

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

    • MULTIHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
    • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
    • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
    • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
    • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
    • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive MULTIHANCE.

    Do not receive MULTIHANCE if you have had a severe allergic reaction to GBCAs including gadobenate dimeglumine, or any of the ingredients in MULTIHANCE.

    Before receiving MULTIHANCE, tell your healthcare provider about all your medical conditions, including if you:

    • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
    • are pregnant or plan to become pregnant. It is not known if MULTIHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as MULTIHANCE is received during pregnancy
    • have kidney problems, diabetes, or high blood pressure.
    • have had an allergic reaction to dyes (contrast agents) including GBCAs

    What are the possible side effects of MULTIHANCE?

    • See “What is the most important information I should know about MULTIHANCE?”
    • Allergic reactions. MULTIHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.

    The most common side effects of MULTIHANCE include: nausea, headache, feeling hot, or burning at the injection site.

    These are not all the possible side effects of MULTIHANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    General information about the safe and effective use of MULTIHANCE.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about MULTIHANCE that is written for health professionals.

    What are the ingredients in MULTIHANCE?
    Active ingredient: gadobenate dimeglumine
    Inactive ingredients: water

    Manufactured by: BIPSO GmbH-78224 Singen (Germany)
    Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831
    US Patent No. 4,916,246
    For more information, go to www.imaging.bracco.com or call 1-800-257-5181.

    This Medication Guide has been approved by the U.S. Food and Drug Administration

    Issued: 04/2018
    COEB403

    Download PDF