Vueway

RECENT MAJOR CHANGES Indications and Usage ( 1 ) 2/2026 Dosage and Administration Recommended Dosage ( 2.1 ) 2/2026 Directions for Use of Imaging Bulk Package ( 2.5 ) 11/2025

1 INDICATIONS AND USAGE Vueway ® 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) Vueway 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 The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of Vueway for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously. 2.2 Administration and Imaging Instructions Administer Vueway as an intravenous bolus injection, manually or by compatible power injector, at approximately 2 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. Use aseptic technique for all handling and administration of Vueway. Visually inspect Vueway for particulate matter and discoloration prior to administration. Do not use the solution if any particulate matter is present or the solution is discolored. Do not mix with other medications because of the potential for chemical incompatibility. Prime intravenous line before use. Contrast MRI can begin immediately following the injection of Vueway. 2.3 Directions for Use of Single-Dose Vial and Pre-filled Syringe Vial Pierce the rubber stopper only once. Aseptically draw up Vueway into a disposable syringe and use immediately. If solidification occurs in the vial due to cold exposure, bring the vial of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. Discard any unused portion. Pre-filled syringe Remove the tip cap of the syringe, screw the plunger rod and use immediately. All luer connections should be gently hand tightened without over tightening, to ensure secure connections and to prevent damage to the device. Pre-filled syringes must not be frozen. Frozen pre-filled syringes of Vueway should be discarded. Discard any unused portion. 2.4 Directions for Use of Pharmacy Bulk Package Vueway Pharmacy Bulk Package (PBP) is not for direct infusion. Perform the transfer of Vueway from the PBP in an aseptic work area, such as laminar flow hood, using aseptic technique and suitable transfer device for filling empty sterile syringes. Penetrate the closure only one time. Once the container closure is punctured, do not remove the PBP from the aseptic work area. Use each individual dose of Vueway promptly following withdrawal from the PBP. Use the contents of the PBP within 24 hours at room temperature after puncture. If solidification occurs in the PBP due to cold exposure, bring the PBP of Vueway to room temperature before use and inspect to ensure that the solution is clear and colorless to yellow without any particulate matter or discoloration. 2.5 Directions for Use of Imaging Bulk Package Vueway Imaging Bulk Package (IBP) is not for direct infusion. The IBP is for use 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. This allows for the administration of multiple single doses of Vueway to multiple patients. See drug and device labeling for information on devices indicated for use with this IBP and techniques to help assure safe use. The Vueway IBP is to be used only in a room designated for performing radiological procedures that involve administration of a contrast agent. Utilize aseptic technique for penetrating the container closure of the IBP and transferring Vueway. 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 IBP. During the entire period of use, ensure that the contents of the Vueway IBP container remain in continuous contact with the automated contrast injector system, contrast management syst …

3 DOSAGE FORMS AND STRENGTHS Injection: 0.5 mmol/mL of gadopiclenol as a clear, colorless to yellow aqueous solution available as: Strength Packaging 1.5 mmol/3 mL (0.5 mmol/mL) 3.75 mmol/7.5 mL (0.5 mmol/mL) 5 mmol/10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL) Single-dose vials (glass) 3.75 mmol/7.5 mL (0.5 mmol/mL) 5 mmol/10 mL (0.5 mmol/mL) 7.5 mmol/15 mL (0.5 mmol/mL) Single-dose prefilled syringes (plastic) 15 mmol/30 mL (0.5 mmol/mL) 25 mmol/50 mL (0.5 mmol/mL) 50 mmol/100 mL (0.5 mmol/mL) Pharmacy bulk package (glass) 15 mmol/30 mL (0.5 mmol/mL) 25 mmol/50 mL (0.5 mmol/mL) 50 mmol/100 mL (0.5 mmol/mL) Imaging Bulk Package (glass) Injection: 0.5 mmol/mL of gadopiclenol in single-dose vials, single-dose prefilled syringes, pharmacy bulk packages, and imaging bulk packages ( 3 )

4 CONTRAINDICATIONS Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact Bracco Diagnostics Inc. at 1-800-257-5181 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 Vueway was evaluated in 1,083 patients who received Vueway at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose). A total of 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg. Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female. The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups. Overall, approximately 4.6% of subjects receiving the labeled dose reported one or more adverse reactions. Table 1 lists adverse reactions that occurred in > 0.2% of patients who received 0.05 mmol/kg Vueway. Table 1. Adverse Reactions Reported in > 0.2% of Patients Receiving Vueway in Clinical Trials Adverse Reaction Vueway 0.05 mmol/kg (n=744) (%) Injection site pain 0.7 Headache 0.7 Nausea 0.4 Injection site warmth 0.4 Injection site coldness 0.3 Dizziness 0.3 Localized swelling 0.3 Erythema 0.3 Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg Vueway included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, injection site paresthesia, Cystatin C increase, and blood creatinine increase. Adverse Reactions in Pediatric Patients The overall safety profile observed in pediatric patients was similar to the safety profile of adult patients [see Use in Specific Populations ( 8.4 )] . 6.2 Postmarketing Experience The following additional adverse reactions have been identified during postmarketing use of Vueway or other 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

8 USE IN SPECIFIC POPULATIONS Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1 ) 8.1 Pregnancy Risk Summary There are no available data on Vueway use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. GBCAs cross the placenta and result in fetal exposure. In human placental imaging studies, contrast was visualized in the placenta and fetal tissues after maternal GBCA administration. Based on animal studies, use of GBCAs during pregnancy may result in fetal gadolinium retention. Published epidemiological studies on the association between GBCAs and adverse fetal outcomes have reported inconsistent findings and have important methodological limitations (see Data ) . In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of Vueway during organogenesis (see Data ) . Because of the potential risks of gadolinium to the fetus, use Vueway only if imaging is essential during pregnancy and cannot be delayed. The background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% respectively. Data Human Data Available data regarding exposure to GBCAs during pregnancy from published epidemiological studies are not sufficient to assess the potential risk of adverse fetal and neonatal effects that may be associated with GBCAs. A retrospective cohort study of over 1.4 million pregnancies in Ontario, Canada, comparing pregnant women who had a GBCA MRI to pregnant women who did not have an MRI, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving GBCA MRI. Limitations of this study include a lack of comparison with non-contrast MRI and lack of information about the maternal indication for MRI. Another retrospective cohort study of over 11 million pregnancies in the Medicaid database found no increased risk of fetal or neonatal death or Neonatal Intensive Care Unit admission when comparing pregnancies exposed to GBCA MRI versus non-contrast MRI. These two retrospective observational studies assessed a limited number of potential pregnancy outcomes and did not evaluate the full spectrum of potential fetal risk. Animal Data Gadolinium Retention GBCAs administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. GBCAs administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. Reproductive Toxicology Animal reproduction studies conducted with gadopiclenol showed some signs of maternal toxicity in rats at 10 mmol/kg and rabbits at 5 mmol/kg (corresponding to 52 times and 57 times the recommended human dose, respectively). This maternal toxicity was characterized in both species by swelling, decreased activity, and lower gestation weight gain and food consumption. No effect on embryo-fetal development was observed in rats at 10 mmol/kg (corresponding to 52 times the recommended human dose). In rabbits, a lower mean fetal body weight was observed at 5 mmol/kg (corresponding to 57 times the recommended human dose) and this was attributed as a consequence of the lower gestation weight gain. 8.2 Lactation Risk Summary There are no data on the presence of gadopiclenol in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate tha …

12.1 Mechanism of Action Gadopiclenol is a paramagnetic molecule (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 signal intensity (brightness) of tissues.

11 DESCRIPTION Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac- [(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ 3 N 3 ,N 6 ,N 9 -1(2,6)-pyridina-κN 1 -cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ 3 O 1 ,O 1 ',O 1 '')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C 35 H 54 GdN 7 O 15 . Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2 . Table 2. Physiochemical properties of Vueway Parameter Value Density at 20°C 1.211 g/cm 3 Mean viscosity at 20°C 12.6 mPa.s Mean viscosity at 37°C 7.6 mPa.s Osmolality at 37°C 850 mOsm/kg water pH 7.0 - 7.8 Gadopiclenol Structure

10 OVERDOSAGE Among subjects who received a single 0.3 mmol/kg intravenous dose of gadopiclenol (6 times the recommended dose of Vueway), headache and nausea were the most frequently reported adverse reactions. Gadopiclenol can be removed from the body by hemodialysis [see Clinical Pharmacology ( 12.3 )] .

16 HOW SUPPLIED/STORAGE AND HANDLING HOW SUPPLIED Vueway (gadopiclenol) injection is a clear, colorless to yellow aqueous solution supplied in the following presentations: Strength Sale Unit NDC Single-Dose Vial (glass) 1.5 mmol/3 mL (0.5 mmol/mL) Carton of 1 0270-7020-37 Carton of 10 0270-7020-38 3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 0270-7025-39 Carton of 10 0270-7025-40 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 0270-7030-41 Carton of 10 0270-7030-42 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 0270-7035-43 Carton of 10 0270-7035-44 Single-Dose Prefilled Syringe (plastic) 3.75 mmol/7.5 mL (0.5 mmol/mL) Carton of 1 0270-7040-43 Carton of 10 0270-7040-44 5 mmol/10 mL (0.5 mmol/mL) Carton of 1 0270-7045-45 Carton of 10 0270-7045-46 7.5 mmol/15 mL (0.5 mmol/mL) Carton of 1 0270-7050-47 Carton of 10 0270-7050-48 Pharmacy Bulk Package (glass) 15 mmol/30 mL (0.5 mmol/mL) Carton of 1 0270-7015-45 Carton of 10 0270-7015-91 Carton of 25 0270-7015-46 25 mmol/50 mL (0.5 mmol/mL) Carton of 1 0270-7015-47 Carton of 10 0270-7015-81 Carton of 25 0270-7015-48 50 mmol/100 mL (0.5 mmol/mL) Carton of 1 0270-7015-63 Carton of 10 0270-7015-66 Carton of 12 0270-7015-65 Imaging Bulk Package (glass) 15 mmol/30 mL (0.5 mmol/mL) Carton of 1 0270-7015-67 Carton of 10 0270-7015-75 Carton of 25 0270-7015-72 25 mmol/50 mL (0.5 mmol/mL) Carton of 1 0270-7015-68 Carton of 10 0270-7015-76 Carton of 25 0270-7015-73 50 mmol/100 mL (0.5 mmol/mL) Carton of 1 0270-7015-69 Carton of 6 0270-7015-74 Carton of 10 0270-7015-77 Storage and Handling Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature]. Do not freeze Pre-filled syringes.