Gadobutrol Prescribing Information
Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of gadobutrol injection have not been established with intrathecal use. Gadobutrol injection is not approved for intrathecal use
- Chronic, severe kidney disease (GFR <30 mL/min/1.73m
2), or - Acute kidney injury.
Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following gadobutrol injection administration
- Before gadobutrol injection administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to gadobutrol injection.
- Administer gadobutrol injection only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
Most hypersensitivity reactions to gadobutrol injection have occurred within half an hour after administration. Delayed reactions can occur up to several days after administration. Observe patients for signs and symptoms of hypersensitivity reactions during and following gadobutrol injection administration.
Warnings and Precautions, Acute Respiratory Distress Syndrome (
Acute respiratory distress syndrome (ARDS) has been reported in patients administered gadobutrol injection and may be characterized by severe hypoxemia requiring oxygen support and mechanical ventilation. These manifestations may resemble an immediate hypersensitivity reaction with onset of respiratory distress within <30 minutes to 24 hours after gadobutrol injection administration. For patients demonstrating respiratory distress after gadobutrol injection administration, assess oxygen requirement and monitor for worsening respiratory function.
- Gadobutrol injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
- To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients, including term neonates ()
1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)Gadobutrol injection is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.
- To assess the presence and extent of malignant breast disease in adult patients ()
1.2 MRI of the BreastGadobutrol injection is indicated for use with MRI in adult patients to assess the presence and extent of malignant breast disease.
- To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates ()
1.3 Magnetic Resonance Angiography (MRA)Gadobutrol injection is 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.
- To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ()
1.4 Cardiac MRIGadobutrol injection is indicated for use in cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
- Recommended dose for adults and pediatric patients (including term neonates) is 0.1 mL/kg body weight ()
2.1 Recommended DoseThe recommended dose of gadobutrol injection for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.
Table 1: Volume of Gadobutrol Injection by Body Weightfor
Cardiac MRI, the dose is divided into 2 separate, equal injectionsBody Weight (kg)Volume to be Administered (mL)2.5
0.25
5
0.5
10
1
15
1.5
20
2
25
2.5
30
3
35
3.5
40
4
45
4.5
50
5
60
6
70
7
80
8
90
9
100
10
110
11
120
12
130
13
140
14
- Administer as an intravenous bolus injection ()
2.2 Administration Guidelines- Gadobutrol injection is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered.
- Use sterile technique when preparing and administering gadobutrol injection.
MRI of the Central Nervous System- Administer gadobutrol injection as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
- Follow gadobutrol injection with a normal saline flush to ensure complete administration of the contrast.
- Post contrast MRI can commence immediately following contrast administration.
MRI of the Breast- Administer gadobutrol injection as an intravenous bolus by power injector, followed by a normal saline flush to ensure complete administration of the contrast.
- Start image acquisition following contrast administration and then repeat sequentially to determine peak intensity and wash-out.
MR Angiography- Image acquisition should coincide with peak arterial concentration, which varies among patients.
Adults- Administer gadobutrol injection by power injector, at a flow rate of approximately 1.5 mL/second, followed by a 30 mL normal saline flush at the same rate to ensure complete administration of the contrast.
Pediatric patients- Administer gadobutrol injection by power injector or manually, followed by a normal saline flush to ensure complete administration of the contrast.
Cardiac MRI- Administer gadobutrol injection through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent.
- Administer gadobutrol injection as two (2) separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.
- Administer gadobutrol injection via a power injector at a flow rate of approximately 4 mL/second and follow each injection with a normal saline flush of 20 mL at the same flow rate.
- Follow injection with a normal saline flush ()
2.2 Administration Guidelines- Gadobutrol injection is formulated at a higher concentration (1 mmol/mL) compared to certain other gadolinium based contrast agents, resulting in a lower volume of administration. Use Table 1 to determine the volume to be administered.
- Use sterile technique when preparing and administering gadobutrol injection.
MRI of the Central Nervous System- Administer gadobutrol injection as an intravenous injection, manually or by power injector, at a flow rate of approximately 2 mL/second.
- Follow gadobutrol injection with a normal saline flush to ensure complete administration of the contrast.
- Post contrast MRI can commence immediately following contrast administration.
MRI of the Breast- Administer gadobutrol injection as an intravenous bolus by power injector, followed by a normal saline flush to ensure complete administration of the contrast.
- Start image acquisition following contrast administration and then repeat sequentially to determine peak intensity and wash-out.
MR Angiography- Image acquisition should coincide with peak arterial concentration, which varies among patients.
Adults- Administer gadobutrol injection by power injector, at a flow rate of approximately 1.5 mL/second, followed by a 30 mL normal saline flush at the same rate to ensure complete administration of the contrast.
Pediatric patients- Administer gadobutrol injection by power injector or manually, followed by a normal saline flush to ensure complete administration of the contrast.
Cardiac MRI- Administer gadobutrol injection through a separate intravenous line in the contralateral arm if concomitantly providing a continuous infusion of a pharmacologic stress agent.
- Administer gadobutrol injection as two (2) separate bolus injections: 0.05 mL/kg (0.05 mmol/kg) body weight at peak pharmacologic stress followed by 0.05 mL/kg (0.05 mmol/kg) body weight at rest.
- Administer gadobutrol injection via a power injector at a flow rate of approximately 4 mL/second and follow each injection with a normal saline flush of 20 mL at the same flow rate.
Gadobutrol injection is a sterile, clear, and colorless to pale yellow solution for injection containing 604.72 mg gadobutrol per mL (equivalent to 1 mmol gadobutrol/mL) supplied in single-dose vials.
- Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. (8.1)