Vueway 485.1 mg/mL
Gadopiclenol · INJECTION · BRACCO DIAGNOSTICS INC
Vueway is a injection containing gadopiclenol at 485.1 mg/mL, taken intravenous. Manufactured by BRACCO DIAGNOSTICS INC.
Key Facts
- Brand Name
- Vueway
- Generic Name
- Gadopiclenol
- NDC Code (Product)
0270-7015- Manufacturer
- BRACCO DIAGNOSTICS INC
- Strength
- 485.1 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA216986
- Marketing Start
- 09/21/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 …
Contraindications
4 CONTRAINDICATIONS Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway ( 4 )
Adverse Reactions
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 p…
Frequently Asked Questions
What is Vueway used for?
Vueway contains Gadopiclenol. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Vueway a controlled substance?
Vueway is not classified as a controlled substance by the DEA.
What is the generic name for Vueway?
The generic name for Vueway is Gadopiclenol. There are 7 other brand versions of Gadopiclenol.
What is the NDC code for Vueway 485.1 mg/mL?
The NDC (National Drug Code) for Vueway 485.1 mg/mL is 0270-7015, listed by BRACCO DIAGNOSTICS INC.