gadobutrol (Rx)

Brand and Other Names:Gadavist
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Dosing & Uses

AdultPediatricGeriatric

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

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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

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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
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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.

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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)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Gadavist intravenous
-
2 mmol/2 mL (1 mmol/mL) vial
Gadavist intravenous
-
7.5 mmol/7.5 mL (1 mmol/mL) solution
Gadavist intravenous
-
10 mmol/10 mL (1 mmol/mL) solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
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) 2021 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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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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.

Tier Description
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.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.