Dosing & Uses
Dosing Form & Strengths
Injectable solution
- 1mmol/mL (ie, 604.72mg/mL)
MRI Contrast
0.1 mmol/kg (0.1 mL/kg) IV bolus
CNS and BBB
- Indicated to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
- Infuse at rate 2 mL/second
- Flush IV cannula with 0.9% NaCl after injection
Breast
- Indicated for use with MRI to assess the presence and extent of malignant breast disease
- Flush IV cannula with 0.9% NaCl after injection
Magnetic resonance angiography
- Indicated for use in magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease
- Infuse at rate 1.5 mL/second
- Flush IV cannula with 30 mL of 0.9% NaCl after injection
Cardiac
- Indicated for cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adults with known or suspected coronary artery disease (CAD)
- Administer through separate IV line in contralateral arm if concomitantly providing continuous infusion of pharmacologic stress agent
- Administer 2 separate bolus IV injections: 0.05 mL/kg (0.05 mmol/kg) at peak pharmacologic stress, followed by 0.05 mL/kg (0.05 mmol/kg) at rest
- Infuse at flow rate of ~4 mL/second; flush each injection with 0.9% NaCl 20 mL at same flow rate
Renal Impairment
Prior to administration, screen all patients for renal dysfunction by obtaining a history and/or laboratory tests (see Black Box Warnings)
No dosage adjustment is recommended for patients with renal impairment
Removed by hemodialysis
Dosing Form & Strengths
Injectable solution
- 1mmol/mL (ie, 604.72mg/mL)
MRI Contrast
0.1 mmol/kg (0.1 mL/kg) IV bolus
Flush IV cannula with 0.9% NaCl after injection
CNS and BBB
- Indicated to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system in adult and pediatric patients (including term neonates)
- Infuse at rate 2 mL/second
Magnetic resonance angiography
- Indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease
- Infuse at rate 1.5 mL/second
Dosage Modifications
Renal impairment
- Prior to administration, screen all patients for renal dysfunction by obtaining a history and/or laboratory tests (see Black Box Warnings)
- No dosage adjustment is recommended for patients with renal impairment
- Removed by hemodialysis
In clinical studies, 1377 patients were 65 years of age or older, while 104 patients were 80 years of age or older
No overall differences in safety or effectiveness were observed between elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients
In general, use in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy
Adverse Effects
1-10%
Headache (1.5%)
Nausea (1.2%)
<1%
Injection site reactions
Dysgeusia
Feeling hot
Dizziness
Vomiting
Rash
Pruritus
Erythema
Dyspnea
Paresthesia
Postmarketing Reports
Cardiac arrest
Nephrogenic systemic fibrosis
Hypersensitivity/anaphylactoid reactions
Warnings
Black Box Warnings
Nephrogenic systemic fibrosis (NSF)
- Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination
- Avoid use in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities
- NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs
- For patients at highest NSF risk, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration
Risk appears highest among patients with:
- Chronic, severe kidney disease (GFR <30 mL/min/1.73 m²), or
- Acute kidney injury
Monitoring
- Screen for acute kidney injury and other conditions that may reduce renal function
- Screen for risk of chronically reduced renal function (eg, aged >60 yr, hypertension, diabetes)
- Estimate glomerular filtration rate (GFR) through laboratory testing
Contraindications
Hypersensitivity; most hypersensitivity reactions to occur within 30 minutes after administration; delayed reactions can occur up to several days after administration
Cautions
History of allergy, renal insufficiency, or drug reaction
Asthma, allergic disorder, hypersensitivity
Risk of nephrogenic systemic fibrosis (NSF) with severe renal impairment
Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease; do not exceed recommended dose
In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis reported with the use of some gadolinium-based contrast agents; do not exceed recommended dose, the risk of acute kidney injury may increase with higher than recommended doses
Extravasation precautions; ensure catheter and venous patency before injection; avoid IM injection
Caution in patients with seizure disorders
In sickle cell anemia, sickling leading to vaso-occlusion reported
Local tissue damage/reactions may occur with extravasation
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 0.01%-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 conditio
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
In MRI, visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with differing proton density and longitudinal/transverse relaxation times; gadobutrol leads to distinct shortening of proton relaxation times in plasma and may improve tissue visualization
Pharmacokinetics
Half-Life: 1.5-2 hr
Distribution: Rapidly distributed in extracellular space
Peak Plasma Concentration: 0.59 mmol/L (2 minutes after injection); 0.3 mmol/L (60 minutes after injection)
Metabolism: None
Excretion: Urine (<90% within 12 hr); feces (minimal)
Clearance: 1.1-1.7 mL/(min•kg)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Gadavist intravenous - | 7.5 mmol/7.5 mL (1 mmol/mL) solution |  | |
| Gadavist intravenous - | 10 mmol/10 mL (1 mmol/mL) solution |  | |
| Gadavist intravenous - | 2 mmol/2 mL (1 mmol/mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
gadobutrol intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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