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DOTAREM- gadoterate meglumine injection


  1. Patient Information
  2. Instruct Patients To Inform Their Healthcare Provider If They:
  3. Gbcas Increase The Risk For Nsf Among Patients With Impaired Elimination Of The Drugs. To Counsel Patients At Risk For Nsf:
  4. Inform Patients That They May Experience:
  5. What Is Dotarem?
  6. 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 What Is The Most Important Information I Should Know About Dotarem?

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

17.1 Nephrogenic Systemic Fibrosis

Instruct Patients To Inform Their Healthcare Provider If They: 

  1. have a history of kidney disease, or
  2. have recently received a GBCA.

Gbcas Increase The Risk For Nsf Among Patients With Impaired Elimination Of The Drugs. To Counsel Patients At Risk For Nsf: 

  • Describe the clinical manifestations of NSF.
  • Describe procedures to screen for the detection of renal impairment.

Instruct the patients to contact their physician if they develop signs or symptoms of NSF following DOTAREM administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.

17.2 Common Adverse Reactions

Inform Patients That They May Experience: 

  • Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
  • Side effects of headache, nausea, abnormal taste and feeling hot.

17.3 General Precautions

  • Pregnancy: Advise pregnant women of the potential risk of fetal exposure to gadoterate[see Use in Specific Populations (8.1)]
  • Gadolinium Retention: Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs[see Warnings and Precautions (5.3)].

Rx Only

image description

Guerbet LLC
821 Alexander Road, Suite 204,
Princeteon, New Jersey 08540

Glass pre-filled syringes manufactured by Catalent, Belgium for Guerbet

Plastic pre-filled syringes manufactured by Liebel-Flarsheim Company LLC, USA for Guerbet

Vials manufactured by Recipharm, France and Liebel-Flarsheim Company LLC, USA for Guerbet

What Is Dotarem? 


  • DOTAREM is a prescription medicine called a gadolinium-based contrast agent (GBCA). DOTAREM, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner.
  • An MRI exam with a GBCA, including DOTAREM, helps your doctor to
    • DOTAREM 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 What Is The Most Important Information I Should Know About Dotarem? 

  • Allergic reactions. DOTAREM 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 DOTAREM include: nausea, headache, pain, or cold feeling at the injection site, and rash.
    These are not all the possible side effects of DOTAREM.
    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 uses of DOTAREM.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about DOTAREM that is written for health professionals.

    What are the ingredients in DOTAREM?
    Active ingredient: gadoterate meglumine
    Inactive ingredients: DOTA, water for injection
    Manufactured by: Catalent (glass pre-filled syringes), Liebel-Flarsheim Company LLC (plastic pre-filled syringes and vials) and Recipharm (vials) for Guerbet
    For more information, go to www.guerbet-us.com or call 1-877-729-6679.

    This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 4/2019



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