Version May 2024
Gadolinium-based contrast agents (GBCAs) increase the risk of nephrogenic systemic fibrosis (NSF) 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. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
Do not administer gadoversetamide to 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, >60 years, hypertension, diabetes), estimate the GFR through laboratory testing.
Do not exceed the recommended gadoversetamide dose. Allow a sufficient period of time for elimination of the drug from the body prior to any readministration.
CNS or liver imaging: IV: 0.1 mmol/kg (0.2 mL/kg)
GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution. Risk for NSF development increases as renal function decreases.
GFR <30 mL/minute/1.73 m2: Use is contraindicated.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). 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 (Ref).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; pharmacokinetics were not significantly altered.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Discomfort at injection site (26%)
1% to 10%:
Cardiovascular: Vasodilation (6%)
Central nervous system: Headache (9%), dizziness (4%), paresthesia (2%), pain (1%)
Gastrointestinal: Dysgeusia (6%), nausea (3%), abdominal pain (2%), diarrhea (2%), dyspepsia (1%)
Local: Injection site reaction (2%)
Neuromuscular & skeletal: Asthenia (2%), back pain (1%)
Respiratory: Rhinitis (2%)
<1%, postmarketing, and/or case reports: Agitation, altered sense of smell, anaphylaxis, anorexia, anxiety, arthralgia, bronchospasm, cardiac arrhythmia, chest pain, confusion, constipation, cough, diaphoresis, diplopia, drowsiness, dysphagia, dyspnea, dystonia, edema, eructation, erythema multiforme, facial edema, fever, hypercalcemia, hypersensitivity reaction, hypertension, hypertonia, hypoesthesia, hypotension, increased serum creatinine, increased thirst, laryngeal edema, laryngismus, leg cramps, malaise, muscle spasm, myalgia, neck pain, neck stiffness, nephrogenic systemic fibrosis, oliguria, pallor, palpitations, pelvic pain, pharyngeal edema, pharyngitis, pruritus, seizure, sialorrhea, sinusitis, skin rash, syncope, tachycardia, thrombophlebitis, tinnitus, tremor, urticaria, vasospasm, vertigo, voice disorder, vomiting, xerostomia
Chronic, severe kidney disease (GFR <30 mL/minute/1.73 m2); acute kidney injury; hypersensitivity to gadolinium, versetamide, or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Neonates up to 4 weeks of age due to their immature renal function
Concerns related to adverse effects:
• 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: [US 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). 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.
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.
Yes
Solution (OptiMARK Intravenous)
330.9 mg/mL (per mL): $4.49
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IV: Administer as rapid bolus injection over 1 to 2 mL/second. Flush line with NS 5 mL to ensure complete injection of medium. Imaging should be completed within 60 minutes of injection.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Optimark: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020976s029lbl.pdf#page=13
CNS imaging: For use with MRI in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
Liver imaging: For use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.
Magnetic resonance angiography (MRA)
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). The manufacturer recommends discontinuing breastfeeding and discarding breast milk for 72 hours following administration.
Signs of hypersensitivity (during and for several hours after procedure); 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)
Gadoversetamide is a paramagnetic agent formed by the chelation of gadolinium and versetamide. 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: 162 ± 25 mL/kg; does not cross intact blood-brain barrier; distribution half-life: 13.3 ± 6.8 minutes
Half-life elimination: 103.6 ± 19.5 minutes; prolonged in renal impairment
Excretion: Urine (~96% within 24 hours)
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