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Gadoterate meglumine: Drug information

Gadoterate meglumine: Drug information
(For additional information see "Gadoterate meglumine: Patient drug information" and see "Gadoterate meglumine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Nephrogenic systemic fibrosis:

Gadolinium-based contrast agents (GBCAs) increase the risk of nephrogenic systemic fibrosis among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. Nephrogenic systemic fibrosis may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk of nephrogenic systemic fibrosis 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 of nephrogenic systemic fibrosis, do not exceed the recommended dose, and allow a sufficient period of time for elimination of the drug from the body prior to any readministration.

Brand Names: US
  • Clariscan;
  • Dotarem
Brand Names: Canada
  • Dotarem
Pharmacologic Category
  • Diagnostic Agent;
  • Gadolinium-Containing Contrast Agent;
  • Macrocyclic Gadolinium-Based Contrast Agent;
  • Radiological/Contrast Media (Ionic);
  • Radiological/Contrast Media, Paramagnetic Agent
Dosing: Adult
CNS imaging

CNS imaging: IV: 0.2 mL/kg (0.1 mmol/kg); may begin imaging immediately after administration.

Dosing: Kidney Impairment: Adult

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.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(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 magnetic resonance imaging

CNS magnetic resonance imaging: Infants, Children, and Adolescents: IV: 0.2 mL/kg (0.1 mmol/kg); may begin imaging immediately after administration.

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

Contraindications

Hypersensitivity to gadoterate meglumine or any component of the formulation

Canadian labeling: Additional contraindications not in US labeling: Subarachnoid or epidural administration

Warnings/Precautions

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 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: [US Boxed Warning]: Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the agents; avoid use unless GBCA enhanced imaging is essential for diagnostic purposes. The risk is highest in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2). NSF may result in debilitating or fatal systemic fibrosis affecting the skin, muscle, and internal organs. Prior to administration, screen all patients for acute kidney injury or other conditions which may reduce renal function; estimate glomerular filtration rate in patients at risk for chronic declines in renal function (eg, age >60, chronic hypertension, diabetes). Do not exceed the recommended dose and allow a sufficient interval between readministration in patients at risk for NSF. The risk for 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.

Warnings: Additional Pediatric Considerations

Pediatric patients may experience a higher incidence of headache than adults.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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); 50 mmol/100 mL (100 mL [DSC])

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)

Generic Equivalent Available: US

May be product dependent

Pricing: US

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

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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)

Administration: Adult

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 (ACR 2023). 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 (ACR 2023); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Stefanos 2023).

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 (Stefanos 2023).

Administration: Pediatric

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 (ACR 2018). 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 (ACR 2018); other sources suggest its utility in extravasation management (Bellin 2002; Reynolds 2014) (see Management of Drug Extravasations for more details).

Medication Guide and/or Vaccine Information Statement (VIS)

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/2018/204781s008lbl.pdf#page=29

Use: Labeled Indications

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

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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).

Breastfeeding Considerations

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.

Monitoring Parameters

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

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Dotarem;
  • (AT) Austria: Clariscan | Cyclolux | Dotagraf | Dotarem;
  • (AU) Australia: Dotarem;
  • (BE) Belgium: Clariscan | Dotagraph | Dotarem;
  • (BG) Bulgaria: Clariscan;
  • (BR) Brazil: Dotarem;
  • (CH) Switzerland: Clariscan | Dotagraf;
  • (CN) China: Dotarem;
  • (CO) Colombia: Clariscan | Dotarem;
  • (CZ) Czech Republic: Clariscan | Dotarem;
  • (DE) Germany: Clariscan | Cyclolux | Dota mr | Dotagita | Dotagraf | Dotarem | Dotavision | Gadotersaeure agfa;
  • (EE) Estonia: Clariscan;
  • (EG) Egypt: Dotarem;
  • (ES) Spain: Clariscan | Dotarem;
  • (FI) Finland: Clariscan | Dotarem;
  • (FR) France: Artirem | Clariscan | Dotarem;
  • (GB) United Kingdom: Dotarem;
  • (GR) Greece: Cyclolux | Dotarem;
  • (HK) Hong Kong: Dotarem;
  • (HR) Croatia: Clariscan | Dotarem;
  • (HU) Hungary: Clariscan | Cyclolux | Dotagraf;
  • (IN) India: Dotavist;
  • (IT) Italy: Claricyclic | Dotarem;
  • (JP) Japan: Magnescope;
  • (KR) Korea, Republic of: Clariscan | Dotarem | Uniray;
  • (LT) Lithuania: Clariscan;
  • (MA) Morocco: Dotarem;
  • (MY) Malaysia: Dotarem;
  • (NL) Netherlands: Clariscan | Dotagraf | Dotarem;
  • (NO) Norway: Clariscan | Dotarem;
  • (PE) Peru: Dotarem;
  • (PH) Philippines: Dotarem;
  • (PL) Poland: Clariscan | Dotarem;
  • (PY) Paraguay: Dotarem;
  • (QA) Qatar: Dotarem;
  • (RU) Russian Federation: Dotarem;
  • (SA) Saudi Arabia: Dotarem;
  • (SE) Sweden: Clariscan | Dotarem;
  • (SI) Slovenia: Clariscan;
  • (SK) Slovakia: Clariscan | Dotarem;
  • (TH) Thailand: Dotarem;
  • (TN) Tunisia: Dotarem;
  • (TW) Taiwan: Dotarem;
  • (ZA) South Africa: Clariscan
  1. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee Opinion No. 656: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2016;127(2):e75-e80. [PubMed 26942391]
  2. American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice. Committee Opinion No. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. Erratum in: Obstet Gynecol. 2018;132(3):786. [PubMed 28937575]
  3. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published April 2023. Accessed May 17, 2023.
  4. American College of Radiology (ACR), North American Society for Cardiovascular Imaging (NASCI), Society for Pediatric Radiology (SPR). ACR-NASCI-SPR practice guideline for the performance of pediatric and adult body magnetic resonance angiography (MRA). [online publication]. Reston (VA): American College of Radiology (ACR); 2010. 16 p. Available at: http://www.acr.org/~/media/D1BC4FB23D4B4005872FDDAE018E0CE7.pdf. Accessed December 21, 2014.
  5. American College of Radiology (ACR), Society for Pediatric Radiology (SPR). ACR-SPR Practice Parameter for the Use of Intravascular Contrast Media. [online publication]. Reston (VA): American College of Radiology (ACR); 2012. 7 p. Available at: http://www.acr.org/~/media/536212D711524DA5A4532407082C89BA.pdf. Accessed December 21, 2014.
  6. Anzalone N, Scarabino T, Venturi C, et al. Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0M) and gadoterate meglumine (0.5M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur J Radiol. 2013;82(1):139-145. [PubMed 21890295]
  7. Bellin MF, Jakobsen JA, Tomassin I, et al; Contrast Media Safety Committee Of The European Society Of Urogenital Radiology. Contrast medium extravasation injury: guidelines for prevention and management. Eur Radiol. 2002;12(11):2807-2812. doi: 10.1007/s00330-002-1630-9 [PubMed 12386778]
  8. Clariscan (gadoterate meglumine) [prescribing information]. Marlborough, MA: GE Healthcare Inc; December 2020.
  9. Dotarem (gadoterate meglumine) [prescribing information]. Princeton, NJ: Guerbet LLC; April 2022.
  10. Dotarem (gadoterate meglumine) [product monograph]. Brantford, Ontario, Canada: July 2023.
  11. Dotarem pharmacy bulk package (gadoterate meglumine) [prescribing information]. Princeton, NJ: Guerbet LLC; April 2018.
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  16. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Management of extravasation injuries: a focused evaluation of noncytotoxic medications. Pharmacotherapy. 2014;34(6):617-32. doi: 10.1002/phar.1396. [PubMed 24420913]
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