Gadoterate Meglumine

Gadoterate Meglumine is a prescription medication used as a contrast agent in MRI of the brain and spine. 

• Gadoterate Meglumine is available under the following different brand names: Dotarem, Clariscan

Common side effects of Gadoterate Meglumine include:

• Headache,
• Nausea,
• Rash, and
• Pain or cold feeling around the IV needle

Serious side effects of Gadoterate Meglumine include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Burning, itching, swelling, scaling, and tightening or hardening of the skin,
• Muscle weakness,
• Joint stiffness in the arms, hands, legs, or feet,
• Deep bone pain in the ribs or your hips,
• Trouble moving,
• Skin redness or discoloration,
• Little or urinating,
• Painful or difficult urination,
• Swelling in the feet or ankles,
• Tiredness, and
• Shortness of breath

Rare side effects of Gadoterate Meglumine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

IV solution

• 0.5 mmol/mL (contains 376.9 mg/mL gadoterate Meglumine)

MRI Contrast

Adult dosage

• 0.2 mL/kg (0.1 mmol/kg) Intravenous bolus infused at a rate of 2 mL/second

Pediatric dosage

• 0.2 mL/kg (0.1 mmol/kg) Intravenous bolus infused at a rate of 1-2 mL/second

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gadoterate Meglumine has no noted severe interactions with any other drugs.
• Gadoterate Meglumine has no noted serious interactions with any other drugs.
• Gadoterate Meglumine has no noted moderate interactions with any other drugs.
• Gadoterate Meglumine has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gadoterate Meglumine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gadoterate Meglumine?”

Cautions

• Gadolinium-based contrast agents increase the risk for NSF among patients with impaired elimination (see Black Box Warnings)
• Anaphylactic and anaphylactoid reactions reported and may involve cardiovascular, respiratory, and/or cutaneous manifestations, including reports of patients experiencing cardiovascular collapse and death
• Acute kidney injury requiring dialysis has occurred in patients with chronically reduced renal function
• Gadolinium retention
  • Gadolinium is retained for months or years in several organs
  • Highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (.g, brain, skin, kidney, liver, and spleen)
  • Duration of retention also varies by tissue and is longest in bone
  • Patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions are at higher risk of gadolinium retention
• Brain deposits
  • FDA investigated the risk of brain deposits following repeated use of GBCAs for MRI in 2015
  • Publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo above 4 contrast MRI scans, long after the last administration
  • As of 2017, the FDA review had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs MRI; all GBCAs may be associated with some gadolinium retention in the brain and other body tissues
  • Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation

Pregnancy and Lactation

• GBCAs cross the placenta and result in fetal exposure and gadolinium retention
• Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive
• estimated background risk of major birth defects and miscarriage for the indicated population is unknown
• All pregnancies have a background risk of birth defect, loss, or other adverse outcomes
• Lactation
  • Estimated infant exposure is 0.001%-0.04% of the maternal dose
  • Unknown whether the effects of the drug on the breastfed infant or the effects the drug on milk production
  • Developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant or from the underlying maternal condition