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Ambelvist®

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

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WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS

Risk Associated with Intrathecal Use

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. AMBELVIST is not approved for intrathecal use.

Nephrogenic Systemic Fibrosis

GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

The risk for NSF appears highest among patients with:

  • Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
  • Acute kidney injury

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

For patients at highest risk for NSF, do not exceed the recommended AMBELVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Ambelvist® is contraindicated in patients with a history of severe hypersensitivity reactions to Ambelvist®. Serious hypersensitivity reactions have occurred with GBCAs. Before Ambelvist® 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 Ambelvist®.

Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible.

Acute kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

Interference with Lesion Visualization: As with other GBCAs, Ambelvist® may obscure certain lesions that are visible on non-contrast MRI. When available, non-contrast MRI images should be reviewed during the interpretation of Ambelvist® MRI scans.

Adverse Reactions: The most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.
 

INDICATIONS

Ambelvist® (gadoquatrane) is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in:

  • the central nervous system (brain, spine, and associated tissues)
  • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)

Please see Full Prescribing Information for Ambelvist®

Medication Guide

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You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Last update:  June 2026

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