Ambelvist® (gadoquatrane) injection 0.1mmol/mL

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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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) to detect and visualize lesions with abnormal vascularity in the:

Brain in white outline inside an orange circle

Central nervous system (CNS) (brain, spine and associated tissues)

Person in white outline in an orange circle

Body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)

Ambelvist supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.^1,3

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

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

Relaxivity (r₁) of Gadoquatrane* in Human Plasma at 37°C

Magnetic Field Strength	Relaxitivity (r₁) (L/mmol/sec)
1.5 T	47
3.0 T	41

*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:

Strength	Package Type	Sale Unit	NDC	MCKESSON MATERIAL
0.2 mmol/2 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 3 vials	50419-321-11	3155744
0.75 mmol/7.5 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-322-11	3155769
1 mmol/10 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-323-11	3155777
1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-324-11	-
0.75 mmol/7.5 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-330-11	-
1 mmol/10 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-331-11	-
1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-332-11	-
3 mmol/30 mL (0.1 mmol/mL)	Imaging Bulk Package	Cartons of 10 bottles	50419-326-11	-
6.5 mmol/65 mL (0.1 mmol/mL)	Imaging Bulk Package	Cartons of 10 bottles	50419-327-11	-

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°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.

References

1. Ambelvist. Prescribing information. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2026

2. Vueway [package insert]. Princeton, NJ: Bracco Diagnostics Inc; 2022.

3. ACR Committee on Drugs and Contrast Media. ACR® Manual on Contrast Media. American College of Radiology. 2025.