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 - | 2 mmol/2 mL (1 mmol/mL) vial |  | |
| Gadavist intravenous - | 10 mmol/10 mL (1 mmol/mL) solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
gadobutrol intravenous
GADOLINIUM-BASED CONTRAST AGENT - INJECTION
COMMON BRAND NAME(S): Clariscan, Dotarem, Elucirem, Eovist, Gadavist, Multihance, Prohance, Vueway
WARNING: This medication may rarely cause kidney damage. The risk of kidney damage is greater if you already have kidney problems, if you are elderly, or if you have high blood pressure or diabetes.Your doctor should check how well your kidneys are working before you receive this medication.See also Side Effects section.
USES: This medication is used before a magnetic resonance imaging (MRI) scan. It belongs to a class of drugs known as gadolinium-based contrast agents (GBCAs). This medication helps the MRI scan make clearer images, so your doctor can more easily diagnose your condition.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start this medication. If you have any questions, ask your health care professional.This medication is given by injection into a vein by a health care provider. The injection is given as directed by your doctor. The dosage is based on your medical condition and weight.
SIDE EFFECTS: Nausea, unpleasant taste, or headache may occur. If any of these effects last or get worse, tell your health care professional.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: kidney problems (such as change in the amount of urine), pain/swelling/redness at the injection site, swelling ankles/feet.Get medical help right away if you have any very serious side effects, including: dark patches on the skin, hardening/tightening of the skin, joint stiffness, hip/rib pain, muscle weakness, trouble moving.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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: Before using this medication, tell your health care professional if you are allergic to it; or to other gadolinium-based contrast agents (such as gadoterate meglumine, gadoteridol, gadoxetate disodium, gadobenate dimeglumine, gadobutrol, or gadopiclenol); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (including being on dialysis), diabetes, high blood pressure.Gadolinium can stay in your body for months or years after getting this medication. Studies have not found harmful effects from gadolinium if your kidneys work normally. For more details talk to your doctor.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
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: Do not share this medication with others.Lab and/or medical tests (such as kidney function) may be done before you use this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: Not applicable. This medication is given once before your imaging test.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised September 2023. 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.
Formulary
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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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