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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
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

Bayer's Gadoquatrane Achieves Positive Phase III Results with Reduced Gadolinium Dose

• Bayer's investigational MRI contrast agent, gadoquatrane, met primary and secondary endpoints in Phase III QUANTI studies. • Gadoquatrane uses 60% less gadolinium (0.04 mmol Gd/kg) compared to standard macrocyclic GBCAs (0.1 mmol Gd/kg). • The QUANTI program included studies in adults with CNS and other body region pathologies, as well as a pediatric study. • Bayer plans to submit a comprehensive data package to health authorities globally to seek marketing authorization for gadoquatrane.

Zydus Lifesciences Gains USFDA Approval for Enzalutamide Formulations

• Zydus Lifesciences has received USFDA approval for Enzalutamide capsules (40 mg) for metastatic castration-resistant prostate cancer. • The company also received tentative approval for Enzalutamide tablets (40 mg and 80 mg) for castration-resistant and metastatic castration-sensitive prostate cancer. • These approvals mark Zydus's 400th approval, with over 465 ANDAs filed since FY 2003-04, strengthening its oncology portfolio. • The approved drugs will be manufactured at Zydus's facilities in Moraiya and SEZ, Ahmedabad, with significant market potential in the US.
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