Version May 2024
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with noncontrast-enhanced 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 per 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.
For patients at highest risk for NSF, do not exceed the recommended gadofosveset dose. Allow a sufficient period of time for elimination of the drug from the body prior to readministration.
Angiography imaging: IV: 0.03 mmol/kg (0.12 mL/kg).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
GFR ≥60 mL/kg/m2: No dosage adjustment necessary.
GFR <60 mL/kg/m2: 0.01 to 0.02 mmol/kg; use with caution. Risk for NSF development increases as renal function decreases.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Ref). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first to 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. Limited data suggest pharmacokinetics of gadofosveset in patients with hepatic disease do not differ substantially.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Vasodilation (3%), hypertension (1%)
Central nervous system: Headache (4%), paresthesia (3%), burning sensation (2%), dizziness (1%), sensation of cold (1%)
Dermatologic: Pruritus (5%)
Gastrointestinal: Nausea (4%), dysgeusia (2%)
Local: Bruising at injection site (2%)
<1%, postmarketing, and/or case reports: Acute renal failure, anaphylactoid reaction, anaphylaxis, nephrogenic systemic fibrosis (NSF/NFD), prolonged QT interval on ECG
History of prior hypersensitivity to any gadolinium-based contrast agent.
Concerns related to adverse effects:
• 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 agent (GBCA) 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.
• QTc prolongation: Rare cases of QTc prolongation have been observed with gadofosveset use. Data from pooled safety studies have demonstrated that the administration of gadofosveset resulted in minimal changes to the QTc interval as compared to placebo (means of 2.8 msec and 3.2 msec respectively). Consider baseline and follow up ECG in patients at increased risk of arrhythmias due to QTc prolongation (eg, underlying cardiac disease, concurrent medications). Patients should be monitored for at least 1 hour after the administration of gadofosveset.
Disease-related concerns:
• 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. Dosage reductions may be necessary. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
No
Solution (Ablavar Intravenous)
244 mg/mL (10 mL): $145.90
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.
IV: Administer as an intravenous bolus injection over a period up to 30 seconds through a dedicated IV line separate from other medications. Flush line with 25-30 mL NS after administration to ensure complete injection of medium. Imaging should be completed within 1 hour of injection.
Angiography imaging: Contrast medium agent used in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.
Vasovist [Hungary, Turkey] may be confused with Gadavist brand name for gadobutrol [U.S.]; Gadovist brand name for gadobutrol [Canada and multiple international markets]; Magnevist brand name for gadopentetate dimeglumine [U.S., Canada, and multiple international markets]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Gadolinium-based contrast agents may cross the placenta (ACOG 723 2017; ACR 2018).
Use of gadolinium-based contrast agents in pregnancy is controversial and should be limited. A gadolinium-based contrast agent 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 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 does not recommend use in breastfeeding women unless diagnostic imaging is essential and cannot be obtained by noncontrast MRA (consider the long half-life of gadofosveset).
Baseline ECG if risk factors for QTc prolongation/torsade de pointes; baseline electrolytes (including potassium, calcium and magnesium); screen for renal impairment (all patients); baseline renal function in patients at risk of NSF and follow-up evaluation with renal dysfunction; signs of hypersensitivity (during and for several hours after procedure); short- and long-term monitoring of signs and symptoms of NSF/NFD (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).
Gadofosveset is a gadolinium-containing paramagnetic agent that reversibly binds to albumin in the plasma. Exposure to an external magnetic field induces a large local magnetic field in exposed blood vessels. 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. The binding of gadofosveset to albumin prolongs the period of time gadofosveset resides intravascularly, enhances T1 relaxivity up to 10 times greater than nonprotein bound gadolinium chelates and provides a longer imaging window.
Onset of action: 5 to 7 minutes
Duration: ~1 hour
Distribution: Vdss: 148 ± 16 mL/kg
Protein binding: 80% to 87% (predominantly to albumin)
Metabolism: Negligible
Half-life elimination: 16.3 ± 2.6 hours; moderate renal impairment: 49 hours; severe renal impairment: 70 hours
Excretion: Urine (79% to 94% as unchanged drug); feces (~5%)
Altered kidney function: Clearance decreases substantially as renal function decreases. AUC increased 1.75-fold in patients with moderate (CrCl 30 to 50 mL/minute) and 2.25-fold in patients with severe renal impairment (CrCl <30 mL/minute).
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