PRODUCT INDICATIONS: AdreView™ (Iobenguane I 123 Injection) is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. AdreView is also indicated for the 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 )

Important Risk and Safety Information About AdreView™ (Iobenguane I 123 Injection)

CONTRAINDICATIONS:AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. WARNINGS AND PRECAUTIONS — Hypersensitivity Reactions: Hypersensitivity reactions have followed AdreView administration. Have anaphylactic and hypersensitivity treatment measures available prior to administration. Benzyl Alcohol Toxicity in Infants: AdreView contains benzyl alcohol, which may cause serious reactions in premature or low-birthweight infants. Patients With Severe Renal Impairment: As AdreView is cleared by glomerular filtration and is not dialyzable, these patients may have increased radiation exposure and decreased image quality. Thyroid Accumulation: Administer thyroid blockade to patients at risk of thyroid accumulation of AdreView. Medication Withdrawal: Drugs that block norepinephrine uptake or deplete norepinephrine stores, such as some antihypertensive agents, may decrease AdreView uptake and may lead to a false negative image. When medically feasible, stop these drugs before AdreView administration. Hypertension: AdreView may increase release of norepinephrine from chromaffin granules producing transient hypertension. ADVERSE REACTIONS: Serious hypersensitivity reactions have been reported following AdreView administration. The most common adverse reactions in NDA clinical trials — dizziness, rash, pruritus, flushing, headache, and injection-site reactions — occurred in ≤1.3% of patients. USE IN SPECIFIC POPULATIONS — Pregnancy: Radiopharmaceuticals have the potential to cause fetal harm. It is not known whether AdreView can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. AdreView should be given to a pregnant woman only if clearly needed.Nursing Mothers: It is not known whether AdreView is excreted into human milk; however, iodine 123 is excreted into human milk. A decision should be made regarding whether to interrupt nursing after administration of AdreView or not to administer AdreView at all. Pediatric Use: Safety and effectiveness have not been established in pediatric patients <1 month of age. Geriatric Use: Clinical experience has not identified differences in responses between the elderly and younger patients. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. Consider assessment of renal function in elderly patients prior to AdreView administration.

Prior to AdreView administration, please read the Full Prescribing Information.

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Indications and Important Safety Information