VUEWAY may impair the visualization of lesions seen on non-contrast MRI. The risk of acute kidney injury may increase with increasing dose of the contrast agent.Įnsure catheter and venous patency before injecting as extravasation may occur, and cause tissue irritation. Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.Īcute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Gadolinium retention can be for months or years in several organs after administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration. Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients chronic, severe kidney disease as well as patients with acute kidney injury. VUEWAY Injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY. For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.Chronic, severe kidney disease (GFR 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.The risk for NSF appears highest among patients with:.NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).the central nervous system (brain, spine and surrounding tissues),.Indications VUEWAY Injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: VUEWAY™ (gadopiclenol) solution for injection Princeton, NJ April 2022.Ĩ CLARISCAN™ (gadoterate meglumine) injection for intravenous use. August 2018.ħ DOTAREM ® (gadoterate meglumine) Injection. Full Prescribing Information and Patient Medication Guide. June 2022.Ħ MultiHance ® (gadobenate dimeglumine) Injection. Whippany, NJ April 2022.ĥ ProHance ® (Gadoteridol) Injection. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. September 2022.Ģ Robic C, Port M, Rousseaux O, et al. 1 VUEWAY™ (gadopiclenol) Injection Full Prescribing Information.
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