Gadoterate

Gadoterate meglumine is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. It helps radiologists see abnormalities on images of the central nervous system (CNS), the part of the body that contains the brain and spine, and surrounding tissues.

Gadoterate meglumine comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.

Common side effects include nausea, headache, and pain.

Gadoterate meglumine is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Gadoterate meglumine may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Although rare, serious side effects can occur with gadoterate meglumine use. See "Drug Precautions" section.

Side effects during clinical trials were uncommon, however, the most frequently reported side effects are:

• nausea
• headache
• injection site pain and coldness
• burning sensation

Other side effects reported include:

• feeling cold
• rash 
• sleepiness 
• tiredness 
• dizziness 
• vomiting 
• itching
• tickling, tingling, burning feeling of skin
• altered sense of taste
• pain in extremity 
• anxiety
• high blood pressure
• palpitations (abnormal heartbeat)
• mouth and throat discomfort
• serum creatinine increased
• injection site reactions such as inflammation, leakage into tissue, itching, and warmth

This is not a complete list of gadoterate meglumine side effects. Ask your doctor or pharmacist for more information.

No significant drug interactions have been identified, however, you should tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Nephrogenic systemic fibrosis: Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF). NSF is a rare, serious condition that involves pain and thickening of skin, and excess fibrous connective tissue of the muscle, and internal organs. NSF risk appears highest for certain patients with kidney disease. See "FDA Warning".

Severe allergic reactions: A type of severe allergic reaction called anaphylaxis has occurred with gadoterate meglumine use. Anaphylaxis develops quickly and can cause death. Patients with a history of a reaction to contrast media, bronchial asthma and/or allergic disorders may have an increased risk of serious allergic reaction.

Kidney Injury: Patients with long-term reduced kidney function have an increased risk of developing a sudden onset of kidney injury.

Tissue Injury: Gadoterate meglumine may leak into the tissue surrounding the vein it is injected into, causing irritation.

Before receiving gadoterate meglumine, tell your healthcare provider if you:

• have a history of kidney disease
• have a history of asthma
• have a history of allergic disorders
• have a history of allergic reaction to contrast media
• have recently received a gadolinium-based contrast agent (GBCA)
• Are pregnant or breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Gadoterate meglumine falls into category C. There are no well-controlled studies that have been done in pregnant women. Gadoterate meglumine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

It is not known if gadoterate meglumine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using gadoterate meglumine.

Gadoterate meglumine is given directly into a vein (IV) by a healthcare provider in a medical setting. The injection usually lasts less than 15 seconds.

Your MRI may begin immediately following the gadoterate meglumine injection.

For adult and children 2 years and older, the recommended dose of gadoterate meglumine is 0.2 mL/kg body weight administered as an intravenous bolus injection, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for children.

Gadoterate meglumine is administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

• The risk for NSF appears highest among patients with:
  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
  • Acute kidney injury.
• Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
• For patients at highest risk for NSF, do not exceed the recommended gadoterate meglumine dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.