Ambelvist (gadoquatrane) is filed as gadolinium-based MRI contrast agent. The sections below restate public label fields stored for this profile.
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 )
12.1 Mechanism of Action Gadoquatrane is a paramagnetic tetrameric macrocyclic non-ionic complex of gadolinium 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 tissues.
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 [see Warnings and Precautions (5.1) ]. 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 m 2 ), 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 [see Warnings and Precautions (5.2) ]. WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning 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 ( 5.1 ). 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. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ), 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 ( 5.2 ).
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.4 ) 5.1 Risks Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of AMBELVIST have not been established with intrathecal use. AMBELVIST is not approved for intrathecal use [see Dosage and Administration (2.1) ] . 5.2 Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m 2 ) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73 m 2 ) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73 m 2 ). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Report any diagnosis of NSF following AMBELVIST administration to Bayer HealthCare (1- 888-842-2937) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch). Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (for example, age > 60 years, diabetes mellitus, or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administrated to a patient. 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 prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent's elimination [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . The usefulness of hemodialysis in the prevention of NSF is unknown. 5.3 Hypersensitivity Reactions With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within half an hour of GBCA administration and resolved with prompt emergency treatment. 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. AMBELVIST is contraindicated in patients with history of severe hypersensitivity reactions to AMBELVIST [see Contraindications (4) ] . Administer AMBELVIST only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation. During and following AMBELVIST administration, observe patients for signs and symptoms of hypersensitivity reactions. 5.4 Gadolinium Retention Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g., brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with gadodiamide causing greater retention than other linear agents such as gadoxetate disodium and gadobenate dimeglumine. Retention is lowest and similar among the macrocyclic GBCAs such as gadoterate meglumine, gadobutrol, gadoteridol, gadopiclenol, and gadoquatrane. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function [see Warnings and Precautions (5.2) ] . There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium. 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 when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible. 5.5 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. 5.6 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.
4 CONTRAINDICATIONS AMBELVIST is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. History of severe hypersensitivity to AMBELVIST. ( 4 )
Dizziness (≥0.2%); Headache (≥0.2%); Injection site reactions (≥0.2%); Nausea (≥0.2%); Vomiting (≥0.2%); Feeling hot (≥0.2%); Paresthesia (≥0.2%); Pruritus (≥0.2%)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.3) ] Most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of AMBELVIST was evaluated in four clinical studies in a total of 842 patients who received a single 0.01 mmol/kg dose. This safety population included 697 adult patients from two active comparator, cross-over studies [see Clinical Studies (14.1) ], 52 adult patients from a dose-finding study, and 93 pediatric patients [see Use in Specific Populations (8.4) ] . Adult Patients Among the 749 adult patients (who were exposed to gadoquatrane), the mean age was 56 years (range: 18 years to 89 years). Of these patients, 67% were White, 29% Asian, 1% Black or African American, and 3% of other or unspecified race, and 10% were Hispanic or Latino, 76% not Hispanic or Latino, and 14% of unspecified ethnicity. Table 1 lists adverse reactions that occurred in ≥ 0.2% of adult patients who received 0.01 mmol/kg AMBELVIST. Table 1: Adverse Reactions Reported in ≥ 0.2% of Adult Patients Who Received AMBELVIST Adverse Reaction AMBELVIST 0.01 mmol/kg N=749 (%) Dizziness 0.9 Headache 0.9 Injection site reactions Injection site reactions include injection site pain, catheter site pain, injection site coldness, and injection site erythema. 0.7 Nausea 0.5 Vomiting 0.4 Feeling hot 0.4 Paresthesia 0.3 Pruritus 0.3 Adverse reactions that occurred in < 0.2% of adult patients who received 0.01 mmol/kg AMBELVIST included erythema, abdominal discomfort, toothache, feeling cold, decreased glomerular filtration rate, urinary sediment, urinary white blood cells, urticaria, dyspnea, rhinalgia, arthralgia, limb discomfort, hematuria, vertigo, and hyperbilirubinemia. Pediatric Patients Among the 93 pediatric patients, the mean age was 7 years (range: 28 days to less than 18 years). Of these patients, 57% were White, 38% Asian, 1% Black or African American, and 4% of unspecified race, and 14% were Hispanic or Latino, 80% not Hispanic or Latino, and 6% of unspecified ethnicity. Adverse reactions in pediatric patients who received 0.01 mmol/kg AMBELVIST included (each occurring in 1% of patients): apnea, pyrexia, decreased platelet count, erythema, and rash [see Use in Specific Populations (8.4) ] . 6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of GBCAs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders : Acute pancreatitis with onset within 48 hours after GBCA administration. General Disorders and Administration Site Conditions : Fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems with variable onset and duration after GBCA administration [see Warnings and Precautions (5.4) ] Respiratory, Thoracic, and Mediastinal Disorders : Acute respiratory distress syndrome, pulmonary edema. Skin Disorders : Gadolinium-associated plaques
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 ) 2.1 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 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. 2.2 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 [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. 2.3 Directions 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. 2.4 Directions 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 disposables for the automated contrast injection system, contrast management system, or contrast media transfer set (e.g., transfer spike) should be discarded. 2.5 Directions for Use of Pharmacy Bulk Package AMBELVIST Pharmacy Bulk Package (PBP) is not for direct infusion. The PBP is for use with an appropriate transfer device for filling empty sterile syringes. Perform the transfer of AMBELVIST from the PBP in an aseptic work area, such as a laminar flow hood, using aseptic technique. Penetrate the closure only one time. Once the PBP is punctured, do not remove it from the aseptic work area. Use each individual dose of AMBELVIST promptly following withdrawal from the PBP. Withdraw the contents of the PBP within 6 hours after puncture at 20°C to 25°C (68°F to 77°F). Discard any unused portion after 6 hours.
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) ].
According to its FDA label, Ambelvist (gadoquatrane) is approved for: 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) t… For medical advice, please talk to your prescriber or pharmacist.
Ambelvist (gadoquatrane) belongs to the gadolinium-based MRI contrast agent class of medications.
The FDA label lists Ambelvist (gadoquatrane) as: 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. ( 3 ); intravenous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Ambelvist. Availability changes as patents expire.
Yes. The FDA label for Ambelvist (gadoquatrane) carries a Boxed Warning. Excerpt: "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 reacti…" See the full FDA label for the complete warning. For medical advice, please talk to your prescriber or pharmacist.
The FDA Enforcement Report does not show an active/ongoing recall for Ambelvist (gadoquatrane) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Ambelvist (gadoquatrane) as 2026-06-12.
The FDA label lists Bayer HealthCare Pharmaceuticals Inc. as a labeler/manufacturer of Ambelvist (gadoquatrane). Multiple firms may market generics of the same molecule.
The FDA label states: "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]." Follow the packaging insert for the authoritative guidance.
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