Ambelvist Gadoquatrane 257.9 mg/mL Injection

1 INDICATIONS AND USAGE AMBELVIST is 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) 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 central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended dose 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). ( 2.1 ) Administer the dose by intravenous injection, manually or by compatible power injector, at 1 mL/sec to 4 mL/sec followed by a flush of 0.9% sodium chloride injection; for pediatric patients, adjust the flow rate and flush volume based on age. ( 2.2 )

2.1Recommended 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 on Gadolinium Content Each molecule of gadoquatrane contains four gadolinium (Gd) ions [see Description (11) ] . Therefore, the recommended dose of 0.01 mmol/kg of gadoquatrane (administered as AMBELVIST) delivers 0.04 mmol Gd/kg.

2.2Administration 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 [see Warnings and Precautions (5.1) ].

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.

2.3Directions for Use of Single-Dose Containers Single-Dose Vials Pierce the rubber stopper only once. Aseptically draw AMBELVIST into the syringe immediately before use. Each vial of AMBELVIST is intended for one single dose. Discard any unused vial contents. Single-Dose Pre-Filled Syringes Remove the tip cap from the pre-filled syringe immediately before use. Each pre-filled AMBELVIST syringe is for one single dose. Discard any unused syringe contents.

2.4Directions for Use of Imaging Bulk Package AMBELVIST Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use only with an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this IBP. See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use.

The AMBELVIST IBP is to be used only in a room designated for radiological procedures that involve intravascular administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the AMBELVIST IBP and transferring AMBELVIST. Penetrate the container closure only one time with a suitable sterile component of the automated contrast injection system, contrast management system, or contrast media transfer set (e.g., transfer spike) approved or cleared for use with this contrast agent in this IBP.

Once the AMBELVIST IBP is punctured, do not remove it from the work area during the entire period of use. Storage temperature of AMBELVIST IBP after the closure has been entered is 20°C to 25°C (68°F to 77°F). Maximum use time is 6 hours from puncture.

Discard any unused portion 6 hours after puncture of the IBP. After the container closure is punctured, if the integrity of the IBP and the delivery system cannot be assured through direct continuous supervision, the IBP and all associated…

3 DOSAGE FORMS AND STRENGTHS Injection: 0.1 mmol/mL of gadoquatrane as a clear and colorless to pale yellow solution available as: Strength Package Type 0.2 mmol/2 mL (0.1 mmol/mL) 0.75 mmol/7.5 mL (0.1 mmol/mL) 1 mmol/10 mL (0.1 mmol/mL) 1.5 mmol/15 mL (0.1 mmol/mL) Single-Dose Vials 0.75 mmol/7.5 mL (0.1 mmol/mL) 1 mmol/10 mL (0.1 mmol/mL) 1.5 mmol/15 mL (0.1 mmol/mL) Single-Dose Pre-Filled Syringes 3 mmol/30 mL (0.1 mmol/mL) 6.5 mmol/65 mL (0.1 mmol/mL) Imaging Bulk Packages 3 mmol/30 mL (0.1 mmol/mL) 6.5 mmol/65 mL (0.1 mmol/mL) Pharmacy Bulk Packages Injection: 0.1 mmol/mL of gadoquatrane in single-dose vials, single-dose pre-filled syringes, imaging bulk packages, and pharmacy bulk packages.

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17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Nephrogenic Systemic Fibrosis Inform the patient that AMBELVIST may increase the risk of NSF among patients with impaired elimination of the drug and that NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Instruct the patient to contact their physician if they develop signs or symptoms of NSF following AMBELVIST administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending, or straightening the arms, hands, legs, or feet; pain in the hip bones or ribs; or muscle weakness [see Warnings and Precautions (5.2) ] .

Gadolinium Retention Advise patients that gadolinium is retained for months or years in brain, bone, skin, and other organs following AMBELVIST administration even in patients with normal renal function. The clinical consequences of retention are unknown. Retention depends on multiple factors and is greater following administration of linear GBCAs than following administration of macrocyclic GBCAs [see Warnings and Precautions (5.4) ] .

Pregnancy Advise pregnant women of the potential risk of fetal exposure to AMBELVIST [see Use in Specific Populations (8.1) ].

MEDICATION GUIDE AMBELVIST (am bel' vist) (gadoquatrane) injection, for intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 6/2026 What is the most important information I should know about AMBELVIST?

GBCAs like AMBELVIST may cause serious side effects including death, coma, encephalopathy, and seizures when it is given intrathecally (injection given into the spinal canal). It is not known if AMBELVIST is safe and effective with intrathecal use. AMBELVIST is not approved for this use.

AMBELVIST contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years). It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.

Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium. There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines.

Gadolinium stays in the body more after gadodiamide than after gadoxetate disodium or gadobenate dimeglumine. Gadolinium stays in the body the least after gadoterate meglumine, gadobutrol, gadoteridol, gadopiclenol, and gadoquatrane. People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.

Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body called nephrogenic systemic fibrosis (NSF). Your healthcare provider should screen you to see how well your kidneys are working before you receive AMBELVIST. What is AMBLEVIST?

AMBELVIST is a prescription medicine called a gadolinium-based contrast agent (GBCA). AMBELVIST, like other GBCAs, is injected into your vein and used with a magnetic resonance imaging (MRI) scanner. An MRI exam with a GBCA, including AMBELVIST, helps your healthcare provider to see problems better than an MRI exam without a GBCA.

Your healthcare provider has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam. Who should not receive AMBELVIST? Do not receive AMBELVIST if you have had a severe allergic reaction to AMBELVIST.

Before receiving AMBELVIST, tell your healthcare provider about all your medical conditions, including if you: have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures. have kidney problems, diabetes, or high blood pressure. have had an allergic reaction to dyes (contrast agents) including GBCAs. are pregnant or plan to become pregnant. It is not known if AMBELVIST can harm your unborn baby.

Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as AMBELVIST is received during pregnancy. What are the possible side effects of AMBELVIST? See " What is the most important information I should know about AMBELVIST? " Allergic reactions.

AMBELVIST can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction. The most common side effects of AMBELVIST include: dizziness headache injection site reaction nausea vomiting feeling hot tingling itchy skin These are not all the possible side effects of AMBELVIST.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of AMBELVIST.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about AMBELVIST t…