Medically reviewed on Nov 15, 2018
(gad oh BYOO trol)
- Gadovist 1.0
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Gadavist: 1 mmol/mL (2 mL, 7.5 mL, 10 mL, 15 mL, 30 mL, 65 mL)
Brand Names: U.S.
- Diagnostic Agent
- Gadolinium-Containing Contrast Agent
- Macrocyclic Gadolinium-Based Contrast Agent
- Radiological/Contrast Media, Nonionic (High Osmolality)
- Radiological/Contrast Media, Paramagnetic Agent
Gadobutrol is a gadolinium-containing, nonionic paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.
Rapid into extracellular space
Urine (>90% as unchanged drug); feces (negligible)
Normal renal function: ~1.5 to 2 hours; severe renal dysfunction (CrCl <30 mL/minute): 17.6 hours (mean)
Special Populations: Renal Function Impairment
The elimination half-life was 5.8 hours in mild-to-moderately impaired patients (CrCl 30 to 80 mL/minute) and 17.6 hours in severely impaired patients not on dialysis (CrCl <30 mL/minute). The mean AUC in patients with healthy renal function was 1.1 mmol•h/L compared with 4 mmol•h/L in patients with mild-to-moderate renal impairment, and 11.5 mmol•h/L in patients with severe renal impairment.
Special Populations: Elderly
AUC was slightly higher and clearance slightly lower in elderly patients.
Use: Labeled Indications
Breast malignancy imaging: Contrast medium for use with MRI to assess the presence and extent of malignant breast disease.
CNS imaging: MRI in adults, adolescents, and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the CNS.
Supra-aortic or renal artery angiography: Magnetic resonance angiography (MRA) in adult and pediatric patients (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.
Breast malignancy imaging: Contrast medium for use with MRI to assess the presence and extent of malignant breast disease.
CNS imaging: Contrast medium for MRI of CNS lesions (brain, spine, and associated tissues) and for perfusion studies to diagnose stroke, or to detect focal cerebral ischemia or tumor perfusion.
Contrast-enhanced magnetic resonance angiography: Contrast medium for contrast-enhanced magnetic resonance angiography (CE-MRA).
Renal imaging: Contrast medium for MRI of the kidney.
Severe hypersensitivity reactions to gadobutrol or any component of the formulation.
Diagnostic imaging: IV:
US labeling: Breast malignancy imaging, CNS imaging, and supra-aortic or renal artery angiography: 0.1 mmol/kg (0.1 mL/kg); may begin imaging immediately after administration
Breast malignancy imaging: Usual dose: 0.1 mmol/kg (0.1 mL/kg); maximum: 0.3 mmol/kg (0.3 mL/kg)
General imaging: 0.1 mmol/kg (0.1 mL/kg); if needed, a second dose of 0.1 to 0.2 mmol/kg (0.1 to 0.2 mL/kg) may be repeated once within 30 minutes of the first dose
Exclusion of metastatic or recurrent tumors: 0.3 mmol/kg (0.3 mL/kg)
Perfusion studies: 0.1 to 0.3 mmol/kg (0.1 to 0.3 mL/kg)
Imaging of a single field of view (FOV):
Patient weight <75 kg: 7.5 mL
Patient weight ≥75 kg: 10 mL
Imaging >1 FOV:
Patient weight <75 kg: 15 mL
Patient weight ≥75 kg: 20 mL
Renal imaging: Usual dose: 0.1 mmol/kg (0.1 mL/kg); maximum: 0.3 mmol/kg (0.3 mL/kg)
Refer to adult dosing.
Diagnostic imaging: IV:
US labeling: CNS imaging, supra-aortic or renal artery angiography: Neonates, Children, and Adolescents: Refer to adult dosing
Canadian labeling: CNS imaging/CE-MRA or renal imaging: Newborns, Infants, Children, and Adolescents: 0.1 mmol/kg (0.1 mL/kg); do not exceed recommended dose. Sequential or repeat dosing has not been studied; allow ≥7 days before considering repeat administration.
Dosing: Renal Impairment
Dose adjustment is not recommended; however, use with caution. Risk for NSF development increases as renal function decreases.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure. Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Okada, 2001).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe, 1998; Kuo, 2007).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling; however, based on exclusive renal excretion of gadobutrol, dose adjustment in hepatic impairment is likely unnecessary.
IV: Do not administer other medications in the same IV line simultaneously.
Breast malignancy imaging: Administer as an IV bolus by power injector, followed by NS flush. Post contrast MRI can commence immediately following contrast administration.
CNS imaging: Administer as an IV injection, manually or by power injector, at a rate of ~2 mL/second, followed by a NS flush. Post contrast MRI can commence immediately following contrast administration.
Supra-aortic or renal artery angiography: Image acquisition should coincide with peak arterial concentration, which varies among patients.
Adult: Administer by power injector, at a rate of ~1.5 mL/second, followed by a 30 mL NS flush at the same rate.
Pediatric: Administer manually or by power injector; followed by a NS flush.
Canadian labeling: For perfusion studies, automatic injector is recommended at an infusion rate of 3 to 5 mL/second
May be a vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate hyaluronidase antidote; elevate extremity.
Hyaluronidase: Intradermal or SubQ: Inject a total of 1 to 1.7 mL (15 units/mL) as five separate 0.2 to 0.3 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Reynolds 2014; Zenk 1981) or injection of a total of 5 mL (150 units/mL) as five separate 1 mL injections around the extravasation site has been also used successfully (Rowlett 2012).
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). If freezing occurs; bring to room temperature before use; do not use unless solution is clear, colorless to pale yellow. Discard any unused drug. Pharmacy bulk package must be discarded within 24 hours after opening in a sterile environment.
There are no known significant interactions.
1% to 10%:
Central nervous system: Headache (2%)
Gastrointestinal: Nausea (1%)
<1%, postmarketing, and/or case reports: Allergic reaction, anaphylactoid reaction, cardiac arrest, convulsions, dizziness, dysgeusia, dyspnea, erythema, feeling hot, flushing, hypotension, injection site pain, injection site reaction, loss of consciousness, malaise, nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD), orthostatic hypotension, pallor, palpitation, paresthesia, parosmia, pruritus, seizure, sensation of cold, skin rash, tachycardia, urinary urgency, urticaria, vertigo, vision disturbance, vomiting, xerostomia
Concerns related to adverse effects:
• Extravasation: May be a vesicant (higher osmolar contrast agents and/or higher volumes are associated with a higher risk). Ensure proper needle or catheter placement prior to and during administration. Monitor infusion site. Avoid extravasation; local tissue irritation may occur.
• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear GBCAs (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.
• Hypersensitivity: Anaphylactic and other hypersensitivity reactions (some fatal) have occurred (with mild to severe cardiovascular, respiratory or dermatologic involvement). Reactions typically occur within 30 minutes of administration; however, delayed reactions may also occur (up to several days following administration). Appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Use with caution in patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions.
• Nephrogenic systemic fibrosis (NSF): [US Boxed Warning]: Gadolinium-based contrast agent (GBCA) exposure increases the risk for NSF in patients with renal impairment; avoid use unless GBCA-enhanced imaging is essential for diagnostic purposes. The risk is highest in patients with acute kidney injury or chronic, severe renal disease (GFR <30 mL/minute/1.73 m2). The risk for NSF appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2), and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration. If NSF occurs, report to manufacturer or the Food and Drug Administration (FDA).
All patients should be screened for renal dysfunction prior to administration; estimate GFR in patients at risk for chronic renal disease (diabetes, chronic hypertension, age >60 years). In patients at risk of NSF, do not exceed the recommended dosage and allow sufficient time (ie, several half-lives) for elimination prior to readministration (avoidance of readministration preferred). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration.
• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency following use of gadolinium agents, generally within 48 hours following administration. In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
• Seizure disorder: Use with caution in patients with a history of seizure disorder; may lower seizure threshold. Injectable anticonvulsant agents should be readily available.
• Scan interpretation: Certain lesions may not appear with contrast-enhanced scan that do appear with noncontrast imaging; use caution when interpreting. Overestimation of extent of malignant disease in MRI of the breast has occurred in up to 50% of patients. A negative MRA study alone should not be used to rule out significant stenosis; performance of MRA for detecting arterial segments with significant stenosis (>50% renal, >70% supra-aortic) has not been shown to exceed 55%.
Renal function; signs of hypersensitivity (during and for several hours after procedure); short- and long-term monitoring of signs and symptoms of NSF/NFD (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye); monitor infusion site for signs/symptoms of extravasation.
Gadolinium-based contrast agents cross the placenta; in general, their use in pregnant women is controversial (ACOG 2016). Use should be avoided unless critical for the care of the mother or fetus, and it is not prudent to wait until after pregnancy. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2015).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, nausea, change in taste, cold or warm sensation at injection site, sensation of warmth, or dizziness. Have patient report immediately to prescriber signs of nephrogenic systemic fibrosis (skin burning, itching, swelling, or scaling; red or dark spots on the skin; hard or tight skin; stiff joints; muscle weakness; hip or rib pain; difficulty moving, bending, or straightening arms, hands, legs, or feet); signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, weight gain), or severe injection site redness, edema, pain or irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about gadobutrol
- Gadobutrol Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- En Español
- 2 Reviews
- Drug class: magnetic resonance imaging contrast media
- FDA Alerts (3)
Other brands: Gadavist