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Gadobutrol

Generic Name
Gadobutrol
Brand Names
Gadavist, Gadovist
Drug Type
Small Molecule
Chemical Formula
C18H31GdN4O9
CAS Number
770691-21-9
Unique Ingredient Identifier
1BJ477IO2L

Overview

Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.

Background

Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.

Indication

Gadobutrol is indicated for use with magnetic resonance imaging for the following diagnostic processes:

Associated Conditions

  • Arterial Occlusive Diseases of the Supra-aortic arteries
  • Coronary Artery Disease (CAD)
  • Malignant Breast Neoplasm
  • Renal artery occlusion

FDA Approved Products

gadobutrol
Manufacturer:Slate Run Pharmaceuticals, LLC
Route:INTRAVENOUS
Strength:604.72 mg in 1 mL
Approved: 2023/11/07
NDC:70436-212
Gadobutrol
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:604.72 mg in 1 mL
Approved: 2023/09/14
NDC:65219-287
Gadavist
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:INTRAVENOUS
Strength:604.72 mg in 1 mL
Approved: 2019/07/12
NDC:50419-325
Gadobutrol
Manufacturer:Fresenius Kabi USA, LLC
Route:INTRAVENOUS
Strength:604.72 mg in 1 mL
Approved: 2023/09/14
NDC:65219-289
Gadavist
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:INTRAVENOUS
Strength:604.72 mg in 1 mL
Approved: 2020/08/13
NDC:50419-325

Singapore Approved Products

GADOVIST 1MMOL/ML PREFILLED SYRINGE 5.0 ML
Manufacturer:BAYER AG
Form:INJECTION
Strength:604.720 MG/ML(EQUIV. 1.0 MMOL)
Online:Yes
Approved: 2010/05/21
Approval:SIN13807P
GADOVIST INJECTION 1.0 mmol/ml
Manufacturer:BAYER AG
Form:INJECTION
Strength:604.720 mg
Online:Yes
Approved: 2003/08/22
Approval:SIN12399P

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