Dosing & Uses
Dosage Forms & Strengths
- 330.9 mg/mL (0.5mmol/mL)
CNS or Liver MRI
Indicated for use with MRI in abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues; also indicated to enhance visualization of lesions with abnormal vascularity in the liver
0.2 mL/kg (0.1 mmol/kg) IV; infuse peripherally at rate of 1-2 mL/sec
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Abdominal pain (1.8%)
Injection site reaction (2%)
Back pain (1%)
Nephrogenic systemic fibrosis
Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema
Black Box Warnings
Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73m²), hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant
NSF affects internal organs, skin, and muscle and can be fatal
Only use if essential and MRI cannot not provide appropriate diagnostic image
Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses
Severe hypersensitivity reactions including anaphylaxis reported
Acute kidney disease or chronic, severe kidney disease (ie, GFR<30 mL/min/1.73m²); use associated with increased risk for nephrogenic systemic fibrosis (NSF)
Screen all patients for renal dysfunction
Acute renal failure has occurred in patients with pre-existing renal insufficiency; use the lowest necessary dose and evaluate renal function
Nephrogenic systemic fibrosis (NSF) reported in patients with impaired elimination; higher than recommended dosing or repeat dosing appears to increase the risk
Anaphylactoid and other serious hypersensitivity reactions including fatal reactions reported, particularly in patients with history of allergy or drug reactions; monitor patients closely for need of emergency cardiorespiratory support
Thrombotic syndromes, anemia, hepatic/renal impairment, hemoglobinopathies (sickle cell anemia)
Risk of hypotension
Caution with hepatic impairment
History of grand mal seizure
- 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
- Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
- It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
- Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Excreted in milk of lactating rats; official prescribing information advises women to discontinue breastfeeding and discard milk for 72 hr after receiving gadoversetamide
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Nonionic gadolinium contrast agent; paramagnetic ion that develops a magnetic moment when placed in magnetic field that can disrupt water protons in the vicinity leading to an increase in signal intensity (brightness) of tissues
Half-Life: 103.6 minutes (elimination)
Vd: 162 mL/kg
Excretion: Urine (96%)
Hemodialysis: 98% removed by hemodialysis over 3 sessions within 120 hr
Adding plans allows you to compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.