Objective:

To announce the approval of AMBELVIST (gadoquatrane), a low-dose macrocyclic gadolinium-based contrast agent for MRI.

Approach:

Key Findings:

• AMBELVIST is the lowest-dose macrocyclic gadolinium-based contrast agent approved in the US.
• It delivers 60% less gadolinium than agents containing 0.1 mmol gadolinium/kg body weight.
• Increased lesion visualization was reported with combined precontrast and postcontrast MRI sets.

Interpretation:

Safety and effectiveness in pediatric patients were supported by studies in adults and pharmacokinetic data from 93 pediatric patients.

Limitations:

• AMBELVIST carries a boxed warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis.
• It is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST.

Conclusion:

AMBELVIST provides an additional option for contrast-enhanced imaging while reducing gadolinium exposure.

Sources:

• Bayer
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