Version May 2024
CNS, head, and neck imaging: IV: 0.1 mmol/kg (0.2 mL/kg) (maximum single dose: 20 mL); may repeat within 30 minutes if clinically indicated.
GFR >30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Risk for NSF development increases as renal function decreases.
GFR <30 mL/minute/1.73 m2: Use contraindicated.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has been shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe 1998; Kuo 2007).
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling; does not undergo significant hepatic metabolism.
Refer to adult dosing.
(For additional information see "Gadopentetate dimeglumine (United States: Not available): Pediatric drug information")
Note: Dosing presented in mL/kg and mmol/kg; use caution. Parenteral solution contains 0.5 mmol/mL of gadopentetate dimeglumine.
Body, CNS, head, and neck magnetic resonance imaging: Children ≥2 years and Adolescents: IV: 0.2 mL/kg (0.1 mmol/kg); imaging must be completed within 1 hour of injection. Note: Dosing for patients >130 kg (286 pounds) has not been studied.
Children ≥2 years and Adolescents:
GFR >30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; 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.
GFR <30 mL/minute/1.73 m2: Use contraindicated.
Dialysis: There are no pediatric-specific recommendations; based on experience in adult patients, the following has been observed:
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo 2007). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Kuo 2007; Okada 2001).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe 1998; Kuo 2007).
There are no dosage adjustments provided in the manufacturer's labeling; does not undergo significant hepatic metabolism.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache (5%), sensation of cold (localized: ≤2%; includes injection site), dizziness (1%)
Gastrointestinal: Nausea (3%)
<1%, postmarketing, and/or case reports: Abdominal distress, abdominal pain, acute renal failure, agitation, altered sense of smell, anaphylactic shock, anaphylactoid reaction, anaphylaxis, angioedema, anxiety, arthralgia, asthenia, auditory impairment, back pain, bronchospasm, cardiac arrhythmia, chest tightness, chills, coma, conjunctivitis, cough, cyanosis, decreased body temperature, decreased heart rate, deep vein thrombosis, diaphoresis, diarrhea, diplopia, drowsiness, dysgeusia, dyspnea, erythema multiforme, eye irritation, eye pain, facial edema, fatigue, fever, hypertension, hypotension, increased body temperature, increased thirst, injection site reaction (burning sensation at injection site, compartment syndrome, connective tissue disease [fasciitis], localized edema, pain at injection site, phlebitis, skin and soft tissue necrosis, thrombosis, warm sensation at injection site), lacrimation, laryngeal edema, laryngospasm, loss of consciousness, migraine, nephrogenic systemic fibrosis, otalgia, pallor, paresthesia, pharyngeal edema, pruritus, pulmonary edema, pustules, renal insufficiency, respiratory distress, rhinitis, seizure, sensation of cold (generalized), shivering, shock, sialorrhea, skin changes (plaques), skin rash, sneezing, speech disturbance, substernal pain, syncope, tachycardia, throat irritation, thrombophlebitis, toothache, tremor, type IV hypersensitivity reaction, urinary incontinence, urinary urgency, urticaria, vasodilation, visual disturbance, vomiting, xerostomia
Hypersensitivity to gadopentetate dimeglumine or any component of the formulation; chronic severe kidney disease (GFR <30 mL/minute/1.73 m2); acute kidney injury; neonates up to 4 weeks of age due to their immature renal function.
Concerns related to adverse effects:
• Extravasation: Vesicant; ensure proper needle/catheter/line placement prior to and during administration. Monitor infusion site. Avoid extravasation. Skin and soft tissue necrosis, thrombosis, fasciitis, and compartment syndrome have occurred (rare) at injection site or limb used for injection; phlebitis and thrombophlebitis may be observed usually within 24 hours of injection and resolves with supportive treatment.
• 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: Hypersensitivity, including anaphylactic reactions (rare), may occur; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Delayed reactions may also occur (within several hours of administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.
• Nephrogenic systemic fibrosis: [Canadian Boxed Warning] : Gadolinium-based contrast agents (GBCAs) exposure may increase the risk for nephrogenic systemic fibrosis (NSF) in patients with renal impairment; avoid use unless GBCA enhanced imaging is essential for diagnostic purposes. Use is contraindicated in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2), and neonates up to 4 weeks of age. The risk appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). NSF, a potentially fatal disease, affects the skin, muscle, and internal organs. All patients should be screened for renal dysfunction prior to administration; estimate GFR through laboratory testing in patients at risk for chronic renal disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration is preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; contraindicated in patients with acute kidney injury or chronic, severe renal impairment (GFR <30 mL/minute/1.73 m2). Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency, generally within 48 hours following administration. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
Other warnings/precautions:
• Scan interpretation: Use caution when interpreting a contrast-enhanced scan in the absence of a companion unenhanced noncontrast MRI.
Not available in the United States.
Yes
Solution (Magnevist Intravenous)
469.01 mg/mL (per mL): $5.04
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Magnevist: 469.01 mg/mL (10 mL, 15 mL, 20 mL) [contains meglumine, pentetic acid (dtpa)]
IV: Dose should be administered at a rate not to exceed 10 mL per 15 seconds. Complete imaging procedure within 1 hour of injection. Following administration, flush line with NS 5 mL.
Vesicant; 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).
Dose should be administered at a rate not to exceed 10 mL per 15 seconds. Complete imaging procedure within 1 hour of injection. Following administration, flush line with NS 5 mL.
Vesicant; 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).
Note: Not approved in the United States.
CNS imaging: MRI agent to visualize CNS lesions with abnormal vascularity in the brain and spine in adults and children.
Head and neck imaging: MRI agent to visualize head and neck lesions with abnormal vascularity in adults.
Magnetic resonance angiography (MRA)
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See "Warnings/Precautions" section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
There are no known significant interactions.
Gadopentetate dimeglumine crosses the placenta (Marcos 1997).
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 2023).
Gadopentetate dimeglumine is present in breast milk (Kubik-Huch 2000; Rofsky 1993; Schmiedl 1990).
In one study, gadopentetate dimeglumine 0.1 mmol/kg was administered IV to 18 breastfeeding women (postpartum ages not specified). Breast milk was collected over 24 hours (range: 1 to 7 samples per subject, mean 4 ± 1.5 samples). The maximum milk concentration and time of maximum milk concentration varied between subjects; however, gadolium concentrations decreased over time, and increased with volume of milk produced and maternal dose. All concentrations were ≤0.04% of the maternal dose (range of the maximum excreted cumulative dose: 0.001% to 0.04%, mean: 0.009% ± 0.01%) (Kubik-Huch 2000).
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 2023). 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 2023). According to the manufacturer, caution should be used if administered to a breastfeeding patient.
Patient and injection site should be monitored for signs of hypersensitivity for several hours following injection; monitor injection site for extravasation; renal function (prior to administration); short- and long-term monitoring of signs and 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)
Exposure to an external magnetic field induces a large local magnetic field in gadopentetate exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.
Distribution: Vd: 266 ± 43 mL/kg; does not cross intact blood-brain barrier; distribution half-life: 0.2 ± 0.13 hours.
Half-life elimination: 1.6 ± 0.13 hours.
CrCl ≥60 mL/minute: 2.6 ± 1.2 hours.
CrCl 30 to <60 mL/minute: 4.2 ± 2 hours
CrCl <30 mL/minute: 10.8 ± 6.9 hours.
OR
Mild to moderate kidney impairment: 3 to 4 hours.
Severe kidney impairment: ~11 hours.
Excretion: Urine (~91% as gadopentetate within 24 hours).
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