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 approved mGBCA dose. Ambelvist delivers 60% less gadolinium vs GBCAs dosed at 0.1 mmol Gd/kg body weight.

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

Distinct tetrameric structure enables high relaxivity, lower Gd dosing, and high complex stability.

  • 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 tissue 
  • Contains 4 macrocyclic non-ionic complexes of Gd
    Gadoquatrane
    Relaxitivy (r1)
    1.5 T
    Per Molecule
    47.2
     
    Per Gd
    11.8
    3.0 T
    Per Molecule
    40.8
     
    Per Gd
    10.2

      Recomended dose for adults and pediatric patients (including term neonates) is 0.01 mmol gadoquatrane per kg body weigh

      • Use a steril technique when preparing and administration Ambelvist 
      • Follow injection with a 0.9% sodium chloride injection, USP

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

        How supplied

        Single-Dose Containers (Vials)
        2 mL single-dose vials, rubber stoppered, in cartons of 3 - (NDC 50419-323-11)
        7.5 mL single-dose vials, rubber stoppered, in cartons of 10 - (NDC 50419-323-12)
        10 mL single-dose vials, rubber stoppered, in cartons of 10 - (NDC 50419-323-13)
        15 mL single-dose vials, rubber stoppered, in cartons of 10 - (NDC 50419-323-14)

        Single-Dose Containers (Pre-Filled Syringes)
        7.5 mL single-dose pre-filled disposable syringes, in cartons of 5 - (NDC 50419-323-32)
        10 mL single-dose pre-filled disposable syringes, in cartons of 5 - (NDC 50419-323-33)
        15 mL single-dose pre-filled disposable syringes, in cartons of 5 - (NDC 50419-323-34)

        Multiple-Dose Containers (Bottles)
        30 mL Imaging Bulk Package, rubber stoppered, in cartons of 10 - (NDC 50419-323-15)
        30 mL Imaging Bulk Package, rubber stoppered, in cartons of 10 - (NDC 50419-323-16)

        Storage and Handling

        Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]
         

        Ordering Information

        Ambelvist is available through all suppliers currently providing our other imaging products. To establish an account, call Bayer Healthcare LLC's master distributor, McKesson Specialty Distribution, at 1-877-259-4624 (option #1), or contact your local distributor.

        • When purchasing through McKesson Specialty, avoid additional shipping charges and receive a 2% quick pay discount when paying invoices within 30 days
        • You can access HCPCS codes for freestanding clinic reimbursement at ASP +6%

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