NOW APPROVED Ambelvist®

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NOW APPROVED

Ambelvist®

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Ambelvist Is Now Approved

Ambelvist has received FDA approval and is now available for use in your MR suite. Connect with a Bayer representative for more information.

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Mom with child as healthcare worker looks on

Lowest-Dose Macrocyclic Gadolinium-Based Contrast Agent Available1

With this approval, Ambelvist becomes the lowest dose mGBCA in the U.S. Ambelvist has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing: 

  • 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight1
  • 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight2

Indications

Ambelvist is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI):

Brain in white outline inside an orange circle

To detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues)

Person in white outline in an orange circle

To detect and visualize lesions with abnormal vascularity in the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)

Diagram of a molecular structure with multiple Gd3+ labels

Ambelvist: a next-generation mGBCA with a novel tetrameric structure1

  • Ambelvist is a paramagnetic tetrameric macrocyclic non-ionic complex of Gd that develops a magnetic moment when placed in a magnetic field
  • The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in the signal intensity (brightness) of tissues1

References: 1. Ambelvist. Prescribing information. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2026. 2. Vueway [package insert]. Princeton, NJ: Bracco Diagnostics Inc; 2022.

    Relaxivity (r1) of Gadoquatrane* in Human Plasma at 37°C
    Magnetic Field StrengthRelaxivity (r₁) (L/mmol/sec)
    1.5 T47
    3.0 T41

    *Each molecule of gadoquatrane contains 4 chelated gadolinium ions

      Dosage and Administration

      Recommended Dose

      The recommended dose of Ambelvist for adult and pediatric patients, including term neonates, is 0.01 mmol/kg actual body weight (equivalent to an injection volume of 0.1 mL/kg) administered intravenously.

      Clarification of Gadolinium Content

      • Each molecule of gadoquatrane contains four gadolinium (Gd) ions. 
      • Therefore, the recommended dose of 0.01 mmol/kg of gadoquatrane (administered as Ambelvist) delivers 0.04 mmol Gd/kg.

      Administration and Imaging Instructions

      • Administer Ambelvist as an intravenous injection, manually or by compatible power injector, at a flow rate of approximately 1 mL/second to 4 mL/second, followed by a flush of 0.9% sodium chloride injection. For pediatric patients, adjust the flow rate and flush volume based on age.
      • Ambelvist is for intravenous use only and must not be administered intrathecally. 
      • Use aseptic technique when preparing and administering Ambelvist.
      • Visually inspect Ambelvist for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, particulate matter is present, or the container appears damaged.
      • If solidification occurs due to cold exposure, bring Ambelvist to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow.
      • Do not mix Ambelvist with other medications, and do not administer Ambelvist in the same intravenous line simultaneously with other medications because of the potential for chemical incompatibility.
      • Contrast MRI can begin immediately following the injection of Ambelvist.
        Available Presentations

        How Supplied

        Ambelvist (gadoquatrane) injection is a clear and colorless to pale yellow solution available in the following presentations:

        StrengthPackage TypeSale UnitNDC
        0.2 mmol/2 mL
        (0.1 mmol/mL)        		Single-Dose VialCartons of 3 vials50419​-321​-11
        0.75 mmol/7.5 mL
        (0.1 mmol/mL)        		Single-Dose VialCartons of 10 vials50419​-322​-11
        1 mmol/10 mL
        (0.1 mmol/mL)        		Single-Dose VialCartons of 10 vials50419​-323​-11
        1.5 mmol/15 mL
        (0.1 mmol/mL)        		Single-Dose VialCartons of 10 vials50419​-324​-11
        0.75 mmol/7.5 mL
        (0.1 mmol/mL)        		Single-Dose Pre-Filled SyringeCartons of 5 syringes50419​-330​-11
        1 mmol/10 mL
        (0.1 mmol/mL)        		Single-Dose Pre-Filled SyringeCartons of 5 syringes50419​-331​-11
        1.5 mmol/15 mL
        (0.1 mmol/mL)        		Single-Dose Pre-Filled SyringeCartons of 5 syringes50419​-332​-11
        3 mmol/30 mL
        (0.1 mmol/mL)        		Imaging Bulk PackageCartons of 10 bottles50419​-326​-11
        6.5 mmol/65 mL
        (0.1 mmol/mL)        		Imaging Bulk PackageCartons of 10 bottles50419​-327​-11

        Storage and Handling
        Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

        Ordering Information

        Ambelvist can be ordered through all the same suppliers as for other Bayer imaging products. Purchasing from McKesson Specialty 3rd Party Logistics (3PL), Bayer Radiology's primary distributor, allows you to avoid additional shipping charges and receive a 2% quick-pay discount when invoices are paid within 30 days.

        • Call 1-877-259-4624 (option #1) or
        • Contact your local distributor

        For more information on reimbursement and purchasing options, click here.

        If you have a question about reimbursement, please contact Bayer's Reimbursement Hotline Managed by Pinnacle at 1-800-423-7539 or BayerImaging@thepinnaclehealthgroup.com.

          

        IMPORTANT SAFETY INFORMATION AND INDICATIONS

        Read More

        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

        Any individuals depicted on this web page are actors and not actual health care providers or patients.
        Patient Information listed on the Graphical User Interfaces are fictitious examples only and do not contain any actual patient data.

        MRI images throughout this website are actual patient cases but all personal identifiers have been removed or otherwise anonymized. No personally identifiable information is shown.

        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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