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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/03 | Not Applicable | Not yet recruiting | |||
2025/02/26 | Phase 4 | Recruiting | UConn Health | ||
2024/12/12 | Phase 2 | Not yet recruiting | |||
2024/01/25 | Phase 1 | ENROLLING_BY_INVITATION | Subtle Medical | ||
2023/06/23 | Phase 3 | Completed | |||
2023/06/23 | Phase 3 | Completed | |||
2023/04/13 | Early Phase 1 | Completed | Christopher J Chermansky, MD | ||
2022/04/28 | N/A | Completed | |||
2022/01/31 | Phase 4 | Recruiting | |||
2021/06/02 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Fresenius Kabi USA, LLC | 65219-289 | INTRAVENOUS | 604.72 mg in 1 mL | 9/14/2023 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-325 | INTRAVENOUS | 604.72 mg in 1 mL | 8/13/2020 | |
Bayer HealthCare Pharmaceuticals Inc. | 50419-325 | INTRAVENOUS | 604.72 mg in 1 mL | 7/12/2019 | |
Slate Run Pharmaceuticals, LLC | 70436-217 | INTRAVENOUS | 604.72 mg in 1 mL | 4/17/2025 | |
Fresenius Kabi USA, LLC | 65219-281 | INTRAVENOUS | 604.72 mg in 1 mL | 2/1/2023 | |
Slate Run Pharmaceuticals, LLC | 70436-214 | INTRAVENOUS | 604.72 mg in 1 mL | 11/7/2023 | |
Slate Run Pharmaceuticals, LLC | 70436-216 | INTRAVENOUS | 604.72 mg in 1 mL | 4/17/2025 | |
Slate Run Pharmaceuticals, LLC | 70436-217 | INTRAVENOUS | 604.72 mg in 1 mL | 4/17/2025 | |
Slate Run Pharmaceuticals, LLC | 70436-213 | INTRAVENOUS | 604.72 mg in 1 mL | 4/17/2025 | |
Slate Run Pharmaceuticals, LLC | 70436-212 | INTRAVENOUS | 604.72 mg in 1 mL | 11/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
GADOVIST 1MMOL/ML PREFILLED SYRINGE 5.0 ML | SIN13807P | INJECTION | 604.720 MG/ML(EQUIV. 1.0 MMOL) | 5/21/2010 | |
GADOVIST INJECTION 1.0 mmol/ml | SIN12399P | INJECTION | 604.720 mg | 8/22/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Gadobutrol Injection | 国药准字H20223154 | 化学药品 | 注射剂 | 3/22/2022 | |
Gadobutrol Injection | 国药准字H20247072 | 化学药品 | 注射剂 | 4/19/2024 | |
Gadobutrol Injection | 国药准字H20249394 | 化学药品 | 注射剂 | 11/15/2024 | |
Gadobutrol Injection | 国药准字HJ20140513 | 化学药品 | 注射剂 | 4/25/2023 | |
Gadobutrol Injection | 国药准字HJ20140515 | 化学药品 | 注射剂 | 4/25/2023 | |
Gadobutrol Injection | 国药准字H20234395 | 化学药品 | 注射剂 | 10/27/2023 | |
Gadobutrol Injection | 国药准字HJ20140516 | 化学药品 | 注射剂 | 4/25/2023 | |
Gadobutrol Injection | 国药准字H20233921 | 化学药品 | 注射剂 | 7/11/2023 | |
Gadobutrol Injection | 国药准字H20249663 | 化学药品 | 注射剂 | 12/1/2024 | |
Gadobutrol Injection | 国药准字HJ20140514 | 化学药品 | 注射剂 | 4/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
GADOVIST 1.0 gadobutrol 18.1416g/30mL injection vial | 72494 | Medicine | A | 1/17/2000 | |
GADOVIST 1.0 gadobutrol 3.0236g/5mL injection syringe | 72493 | Medicine | A | 1/17/2000 | |
GADOVIST 1.0 gadobutrol 6.0472g/10mL injection syringe | 72518 | Medicine | A | 1/17/2000 | |
GADOVIST 1.0 gadobutrol 4.5354g/7.5mL injection vial | 67048 | Medicine | A | 12/2/1998 | |
GADOVIST 1.0 gadobutrol 1.2094 g/2 mL solution for injection vial | 286854 | Medicine | A | 3/16/2018 | |
GADOVIST 1.0 gadobutrol 39.307 g/65mL injection vial | 416320 | Medicine | A | 5/9/2024 | |
GADOVIST 1.0 Gadobutrol 9.0708g/15mL injection vial | 67047 | Medicine | A | 12/2/1998 | |
GADOVIST 1.0 gadobutrol 4.5354g/7.5mL injection syringe | 67046 | Medicine | A | 12/2/1998 |