Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoterate meglumine is not approved for intrathecal use.
GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadoterate meglumine in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
The risk for NSF appears highest among patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2) or acute kidney injury.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk of chronically reduced renal function (eg, age >60 years, hypertension, diabetes), estimate the 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.
CNS imaging: IV: 0.2 mL/kg (0.1 mmol/kg); may begin imaging immediately after administration.
No dosage adjustment recommended; however, use with caution. The risk for developing nephrogenic systemic fibrosis (NSF) increases as renal function decreases.
Hemodialysis: Gadoterate meglumine is removed by hemodialysis.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Gadoterate meglumine: Pediatric drug information")
Note: Dosing presented in mL/kg and mmol/kg; use precaution. Parenteral solution contains 0.5 mmol/mL of gadoterate meglumine.
CNS MRI: Infants, Children, and Adolescents: IV: 0.2 mL/kg (0.1 mmol/kg); may begin imaging immediately after administration.
There are no dosage adjustments provided in the manufacturer's labeling; however, use with caution; acute kidney injury requiring dialysis has been reported with use in patients with chronic renal dysfunction; risk may be increased with higher doses of contrast agent. Risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.
Hemodialysis: Gadoterate meglumine is removed by hemodialysis.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache (≤1%)
Gastrointestinal: Nausea (≤1)
<1%, postmarketing, and/or case reports: Altered sense of smell, anaphylactoid reaction, anaphylaxis, angioedema, anxiety, bradycardia, bronchospasm, burning sensation, cardiac arrest, cardiac arrhythmia, circulatory shock, coma, conjunctivitis, convulsions, cyanosis, diarrhea, dizziness, drowsiness, dysgeusia, eyelid edema, fatigue, feeling hot, fever, hyperhidrosis, hypersensitivity reaction, hypertension, hypotension, increased lacrimation, increased serum creatinine, inflammation at injection site, injection site pruritus, injection site reaction (including cold, warmth), laryngeal discomfort, laryngospasm, limb pain, malaise, muscle spasm, myasthenia, ocular hyperemia, pain, pain at injection site, palpitations, paresthesia, pharyngeal edema, phlebitis (superficial), presyncope, pruritus, respiratory arrest, sensation of cold, sialorrhea, skin rash, swelling at injection site, syncope, tachycardia, tremor, urticaria, vomiting, weakness
Hypersensitivity to gadoterate meglumine or any component of the formulation
Canadian labeling: Additional contraindications not in US labeling: Subarachnoid or epidural administration
Concerns related to adverse effects:
• Extravasation: May be a vesicant (higher osmolar contrast agents and/or higher volumes are associated with a higher risk). Ensure proper needle or catheter placement prior to and during administration. Monitor infusion site. Avoid extravasation; local tissue irritation may occur.
• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear gadolinium-based contrast agents (GBCAs) (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.
• Hypersensitivity reactions: Anaphylactic and anaphylactoid reactions have occurred (with cardiovascular, respiratory, or dermatologic involvement); some have involved fatalities due to circulatory collapse. Symptoms typically occurred within minutes of administration and resolved with prompt emergency treatment. Prior to administration, assess patients for history of contrast media reaction, bronchial asthma, and/or allergic disorders. Monitor patients closely during and after infusion. If hypersensitivity occurs, begin immediate management. Appropriate equipment, trained personnel and emergency medications should be available during use.
• Nephrogenic systemic fibrosis: The risk for nephrogenic systemic fibrosis (NSF) appears lower in patients with chronic moderate renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with chronic mild renal disease (GFR 60 to 89 mL/minute/1.73 m2). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration. If NSF occurs, report to manufacturer or the Food and Drug Administration.
Disease-related concerns:
• Renal impairment: Dose-dependent acute kidney injury has occurred in patients with chronic renal insufficiency following use of gadolinium agents; administer the lowest dose necessary for adequate imaging. Evaluate renal function in all patients; consider follow-up assessment of renal function in patients with a history of renal dysfunction.
Pediatric patients may experience a higher incidence of headache than adults.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Clariscan: 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 10 mmol/20 mL (20 mL); 50 mmol/100 mL (100 mL)
Dotarem: 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 10 mmol/20 mL (20 mL)
Generic: 2.5 mmol/5 mL (5 mL); 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 10 mmol/20 mL (20 mL); 50 mmol/100 mL (100 mL)
Solution, Intravenous [preservative free]:
Clariscan: 2.5 mmol/5 mL (5 mL)
Dotarem: 2.5 mmol/5 mL (5 mL); 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 50 mmol/100 mL (100 mL)
Solution Prefilled Syringe, Intravenous:
Dotarem: 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 10 mmol/20 mL (20 mL)
Solution Prefilled Syringe, Intravenous [preservative free]:
Clariscan: 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL); 10 mmol/20 mL (20 mL)
Dotarem: 5 mmol/10 mL (10 mL); 7.5 mmol/15 mL (15 mL)
May be product dependent
Solution (Clariscan Intravenous)
2.5MMOL/5ML (per mL): $6.00
5 mmol/10 mL (per mL): $6.00
7.5 mmol/15 mL (per mL): $6.00
10 mmol/20 mL (per mL): $6.00
50 mmol/100 mL (per mL): $6.00
Solution (Dotarem Intravenous)
2.5MMOL/5ML (per mL): $6.36
5 mmol/10 mL (per mL): $3.96
7.5 mmol/15 mL (per mL): $3.36
10 mmol/20 mL (per mL): $3.36
50 mmol/100 mL (per mL): $3.10
Solution (Gadoterate Meglumine Intravenous)
2.5MMOL/5ML (per mL): $4.20
5 mmol/10 mL (per mL): $2.77
7.5 mmol/15 mL (per mL): $2.35
10 mmol/20 mL (per mL): $2.35
50 mmol/100 mL (per mL): $2.17
Solution Prefilled Syringe (Clariscan Intravenous)
5 mmol/10 mL (per mL): $6.60
7.5 mmol/15 mL (per mL): $6.60
10 mmol/20 mL (per mL): $6.60
Solution Prefilled Syringe (Dotarem Intravenous)
5 mmol/10 mL (per mL): $4.63
7.5 mmol/15 mL (per mL): $3.60
10 mmol/20 mL (per mL): $3.60
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Dotarem: 376.9 mg/mL (5 mL, 10 mL, 15 mL, 20 mL, 60 mL, 100 mL)
IV: Administer as an IV bolus injection (by manual injection or power injector). Infuse at a rate of approximately 2 mL/second. To ensure complete injection of contrast agent, flush line with NS after administration.
May be a vesicant (higher osmolar contrast media and higher volumes are associated with a higher risk); ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (Ref). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Ref).
If using hyaluronidase: Intradermal or SUBQ: Dose varies based on the size of infiltration; inject a total of 5 to 250 units (~100 mL contrast reabsorbed per 15 units of hyaluronidase) around the site of extravasation (Ref).
IV: Administer as an IV bolus injection (by manual injection or power injector). To ensure complete injection of contrast agent, flush line with NS after administration.
Neonates, Infants, Children, and Adolescents: Infuse at a rate of 1 to 2 mL/second
May be a vesicant (higher osmolar contrast media and higher volumes are associated with a higher risk); ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (Ref). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (Ref); other sources suggest its utility in extravasation management (Ref) (see Management of Drug Extravasations for more details).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Dotarem: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204781s015lbl.pdf#page=32
CNS imaging: Contrast medium for magnetic resonance imaging (MRI) in adults, adolescents, and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity in the brain (intracranial), spine, and associated tissues
None known.
There are no known significant interactions.
Gadolinium-based contrast agents may cross the placenta (ACOG 723 2017; ACR 2018).
Pregnant patients may be at increased risk for gadolinium retention. Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent with MRI may be considered for use in pregnancy if it will significantly improve diagnostic performance and is expected to improve fetal or maternal outcome (ACOG 723 2017). In addition, use should only be considered if information needed from the MRI study cannot be acquired without using a contrast agent and cannot be deferred until after delivery. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2018).
Gadolinium-based contrast agents may be present in breast milk (ACOG 723 2017; ACR 2018).
Because of the low expected excretion into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 723 2017; ACR 2018). Theoretically, the taste of milk could be altered if it contains contrast media. Women who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2018). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Signs of hypersensitivity (during and after administration); renal function (prior to administration); signs/symptoms of NSF (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye); monitor injection site for signs/symptoms of extravasation
Gadoterate meglumine is a gadolinium-containing paramagnetic macrocyclic ionic contrast agent. Exposure to an external magnetic field induces a local magnetic moment in exposed tissues. This local magnetism enhances water proton relaxation in the vicinity, resulting in an increase in signal intensity (brightness) in tissues. Does not cross intact blood-brain barrier, therefore will only enhance brain lesions if the blood-brain barrier is disrupted or if there is abnormal vascularity.
Onset of action: Imaging may begin immediately after administration
Distribution: 179 ± 26 mL/kg (female); 211 ± 35 mL/kg (male); does not cross intact blood-brain barrier
Protein binding: None
Metabolism: Not metabolized
Half-life elimination: 1.4 ± 0.2 hours (female); 2 ± 0.7 hours (male)
Excretion: Urine (72.9% ± 17% female; 85.4 ± 9.7% male)
Altered kidney function: Following a single 0.1 mmol/kg dose to patients with creatinine clearances of 10-60 mL/minute, gadolinium elimination was delayed. Total clearance decreased in correlation with the degree of renal impairment. Cumulative urinary excretion was ~77% over 48 hours in patients with moderate impairment and ~68% over 72 hours in patients with severe impairment, compared to ~93% over 24 hours in patients with normal renal function.
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