Adreview

Product manufactured by Medi-Physics Inc.

Application Nr Approved Date Route Status External Links
NDA022290 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Adreview Is A Radiopharmaceutical Agent For Gamma-Scintigraphy Indicated For: Use In The Detection Of Primary Or Metastatic Pheochromocytoma Or Neuroblastoma As An Adjunct To Other Diagnostic Tests ( 1.1 ) Scintigraphic Assessment Of Sympathetic Innervation Of The Myocardium By Measurement Of The Heart To Mediastinum (H/m) Ratio Of Radioactivity Uptake In Patients With New York Heart Association (Nyha) Class Ii Or Class Iii Heart Failure And Left Ventricular Ejection Fraction (Lvef) ≤ 35%. Among These Patients, Adreview May Be Used To Help Identify Patients With Lower One And Two Year Mortality Risks, As Indicated By An H/m Ratio ≥ 1.6. ( 1.2 ) Limitations Of Use: In Patients With Congestive Heart Failure, Adreview Utility Has Not Been Established For: Selecting A Therapeutic Intervention Or For Monitoring The Response To Therapy; Using The H/m Ratio To Identify A Patient With A High Risk For Death. 1.1 Pheochromocytoma And Neuroblastoma Adreview Is A Radiopharmaceutical Indicated For Use In The Detection Of Primary Or Metastatic Pheochromocytoma Or Neuroblastoma As An Adjunct To Other Diagnostic Tests. 1.2 Congestive Heart Failure Adreview Is Indicated For Scintigraphic Assessment Of Sympathetic Innervation Of The Myocardium By Measurement Of The Heart To Mediastinum (H/m) Ratio Of Radioactivity Uptake In Patients With New York Heart Association (Nyha) Class Ii Or Class Iii Heart Failure And Left Ventricular Ejection Fraction (Lvef) ≤ 35%. Among These Patients, Adreview May Be Used To Help Identify Patients With Lower One And Two Year Mortality Risks, As Indicated By An H/m Ratio ≥ 1.6. Limitations Of Use: In Patients With Congestive Heart Failure, Adreview Utility Has Not Been Established For: Selecting A Therapeutic Intervention Or For Monitoring The Response To Therapy; Using The H/m Ratio To Identify A Patient With A High Risk For Death.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Iobenguane I-123

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