Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- voclosporin
voclosporin, gadoversetamide. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
Minor (0)
Adverse Effects
1-10%
Headache (9.4%)
Vasodilation (6.4%)
Dizziness (3.7%)
Nausea (3.2%)
Paresthesia (2.2%)
Diarrhea (1.9%)
Abdominal pain (1.8%)
Rhinitis (2%)
Injection site reaction (2%)
Back pain (1%)
Dyspepsia (1%)
<1%
Seizures
Amblyopia
Anorexia
Cough
Diplopia
Dry skin
Dystonia
Flatulence
Hyponatremia
Neck pain
Pallor
Parosmia
Rash
Seizure
Postmarketing Reports
Seizures
Nephrogenic systemic fibrosis
Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema
Warnings
Black Box Warnings
Nephrogenic systemic fibrosis
- Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs
- Avoid use of GBCAs in these patients unless diagnostic information is essential and not available with noncontrasted MRI or other modalities
- NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs
- Highest risk for NSF is among patients with chronic, severe kidney disease (GFR <30 mL/min/1.73²) OR acute kidney injury
- Screen patients for acute kidney injury and other conditions that may reduce renal function
- For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing
- For patients at highest risk for NSF, do not exceed recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration
Contraindications
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)
Cautions
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
Gadolinium retention
- Gadolinium is retained for months or years in several organs
- Highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (eg, brain, skin, kidney, liver, and spleen)
- Duration of retention also varies by tissue and is longest in bone
- Patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions are at higher risk of gadolinium retention
Brain deposits
- FDA investigated the risk of brain deposits following repeated use of GBCAs for MRI in 2015
- 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
- As of 2017, the FDA review had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs MRI; all GBCAs may be associated with some gadolinium retention in the brain and other body tissues
- 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
GBCAs cross the placenta and result in fetal exposure and gadolinium retention
Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive
Estimated background risk of major birth defects and miscarriage for the indicated population is unknown
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes
Lactation
Estimated infant exposure is 0.001%-0.04% of the maternal dose
Unknown whether the effects of the drug on the breastfed infant or the effects of the drug on milk production
Developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant or from underlying maternal condition
Pregnancy Categories
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.Pharmacology
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
Pharmacokinetics
Half-Life: 103.6 minutes (elimination)
Vd: 162 mL/kg
Excretion: Urine (96%)
Hemodialysis: 98% removed by hemodialysis over 3 sessions within 120 hr
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