Version May 2024
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis among patients with impaired elimination of the drugs. Avoid use of gadolinium-based contrast agents 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 for 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 long-term reduced renal function (eg, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing.
For patients at highest risk of nephrogenic systemic fibrosis, do not exceed the recommended gadoxetate dose. Allow a sufficient period of time for elimination of the drug from the body prior to any readministration.
Liver imaging: IV: 0.025 mmol/kg (0.1 mL/kg).
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Risk for NSF development increases as renal function decreases.
End-stage renal disease: Imaging performance decreases due to elevated serum ferritin levels; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.
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).
No dosage adjustments necessary.
Severe hepatic impairment (including patients with elevated bilirubin >3 mg/dL): Imaging performance decreases; if used, complete imaging no later than 60 minutes after administration and use a paired noncontrast and contrast image for diagnosis.
Refer to adult dosing.
Liver imaging: Infants ≥2 months, Children, and Adolescents: Refer to adult dosing.
Infants ≥ 2 months, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Risk for nephrogenic systemic fibrosis (NSF) development increases as renal function decreases.
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).
Infants ≥ 2 months, Children, and Adolescents: No dosage adjustments necessary.
Severe hepatic impairment (including patients with elevated bilirubin >3 mg/dL): Imaging performance decreases; if used, complete imaging no later than 60 minutes after administration and use a paired noncontrast and contrast image for diagnosis.
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: Abdominal pain, akathisia, altered sense of smell, anaphylaxis, asthenia, back pain, bundle branch block, burning sensation at injection site, chest pain, chills, conjunctivitis, cough, dizziness, dysgeusia, dyspnea, eye pruritus, facial edema, fatigue, feeling abnormal, feeling hot, flushing, hyperhidrosis, hypersensitivity reaction, hypoesthesia, hypotension, increased blood pressure, increased serum bilirubin, increased serum iron, injection site reaction, irritation at injection site, laryngeal edema, maculopapular rash, malaise, nephrogenic systemic fibrosis, oral discomfort, pain, pain at injection site, pallor, palpitations, paresthesia, pharyngeal edema, pruritus, respiratory distress, restlessness, rhinitis, sensation of cold, shock, sialorrhea, skin changes (plaques; Ramalho 2017), skin rash, sneezing, tachycardia, tremor, urticaria, vertigo, vomiting, xerostomia
Hypersensitivity to gadoxetate or any component of the formulation.
Concerns related to adverse effects:
• Extravasation: Avoid extravasation; local tissue damage/reactions may occur. Ensure catheter patency prior to administration.
• 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 other hypersensitivity reactions with cardiovascular, respiratory, and cutaneous manifestations (ranging from mild to severe), including shock (rare), have occurred; appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Reactions typically occur within 30 minutes of administration; however, delayed reactions may also occur (up to several days following 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: [US Boxed Warning]: 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. The risk is highest in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2). 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 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. In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.
Disease-related concerns:
• Hepatic impairment: Severe hepatic failure, such as markedly elevated serum bilirubin (>3 mg/dL), may impair imaging performance; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.
• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency following use of other gadolinium agents, generally within 48 hours following administration; risk may be lower with gadoxetate due to its combined renal and hepatic elimination pathways. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring. End-stage renal disease may impair imaging performance due to elevated serum ferritin levels; if used, complete MR imaging within 60 minutes following administration and use both noncontrast and contrast-enhanced images to aid in diagnosis.
Other warnings/precautions:
• Appropriate use: Lesions with minimal or no hepatocyte function (eg, cysts, metastases, certain hepatocellular carcinomas) will generally not accumulate gadoxetate resulting in decreased visualization.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous, as disodium:
Eovist: 0.25 mmol/mL (10 mL, 15 mL)
No
Solution (Eovist Intravenous)
0.25 mol/L (per mL): $17.04
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IV: Administer undiluted as rapid IV bolus injection at a rate of 1 to 2 mL/second. Flush line with NS to ensure complete injection of medium. May begin imaging immediately after administration and may be performed up to 120 minutes post-injection. In patients with elevated ferritin or bilirubin (>3 mg/dL) levels, complete MR imaging within 60 minutes following administration.
IV: Administer undiluted as rapid IV bolus injection at a rate of ~2 mL/second. Flush line with NS to ensure complete injection of medium. May begin imaging immediately after administration and may be performed up to 120 minutes post-injection. In patients with elevated ferritin or bilirubin (>3 mg/dL) levels, complete MR imaging within 60 minutes following administration.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication;
Eovist: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022090s020lbledt.pdf#page=15
Liver imaging: For use with magnetic resonance imaging (MRI) to detect and characterize lesions in patients with known or suspected focal liver disease.
Magnetic resonance angiography (MRA)
Eovist may be confused with Evista
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 10 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).
Signs of hypersensitivity (during and for several hours after procedure); 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)
Gadoxetate is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in 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: 0.21 L/kg; initial distribution in extracellular space, followed by selective uptake by hepatocytes; does not cross intact blood-brain barrier
Protein binding: <10%
Half-life elimination: Healthy volunteers: 0.91 to 0.95 hours; prolonged with hepatic or renal impairment
Excretion: Urine; feces
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