New Tool Designed to Help Educate Physicians on Use of AdreView in Patients with Heart Failure

WHAT: The Interactive Patient Profiler for AdreView is a simulation tool designed to help educate physicians on the use of AdreView (Iobenguane I 123 Injection) to assess mortality risk in patients with heart failure. The tool demonstrates the types of patients where the use of AdreView can provide further information to assist physicians in identifying patients who may have a lower one- and two-year mortality risk, among groups of patients with similar profiles based on other clinical information.

WHY: AdreView, a norepinephrine (NE) analog, is the first FDA-approved imaging agent that visualizes myocardial sympathetic innervation (cardiac nerve activity).  AdreView is a radiopharmaceutical indicated for the scintigraphic assessment of myocardial sympathetic innervation to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35 percent. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risk, as indicated by a heart to mediastinum (H/M) ratio ≥ 1.6. In NDA clinical studies, an AdreView Score –H/M ratio - of ≥1.6 was associated with a 99 percent probability of survival at one year (negative predictive value, NPV). 1 In patients with congestive heart failure (CHF), utility has not been established for selecting therapy, monitoring response to therapy, or identifying a patient with a high risk of death. AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate.

Hypersensitivity reactions have followed AdreView administration. Drugs known or expected to reduce norepinephrine uptake or stores may cause a falsely low H/M. Delayed clearance in patients with severe renal impairment may increase radiation dose and decrease image quality. Imaging in patients with neurological diseases that affect the sympathetic nervous system may show decreased cardiac uptake of AdreView, independent of heart disease. Administer thyroid blockade to patients at risk of thyroid accumulation of AdreView. AdreView may increase release of norepinephrine from chromaffin granules producing transient hypertension.

HOW: The simulation tool consists of five levels, each of which is based on a different age range containing three patient profiles. The patient profiles are based on the characteristics of actual patients from the ADMIRE-HF Study. In addition to evaluating the medical history, users can review the results of the AdreView planar scan for each individual patient to help determine if a patient may have a lower one- and two-year mortality risk. Points are scored for each correct assessment by the users.  At the end of each level there is a bonus question, designed to further test the participant’s knowledge about AdreView and earn more points.

WHO: The Interactive Patient Profiler is aimed at physicians who are involved with treating or managing patients with NYHA Class II or Class III heart failure and left ventricular ejection fraction ≤35%. This may include cardiologists, nuclear cardiologists, electrophysiologists or other physicians who specialize in the diagnosis and management of heart failure.

WHERE: Live demonstrations are available via a WebEx appointment.

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

INDICATIONS: AdreView is a radiopharmaceutical indicated for scintigraphic imaging assessment of sympathetic innervation of the myocardium. AdreView assists in the evaluation of patients with NYHA Class II or Class III heart failure and left ventricular ejection fraction ≤35% to help identify patients with lower one- and two-year mortality risks, as indicated by a heart-to-mediastinum (H/M) ratio of radioactivity uptake ≥1.6. Limitations: In patients with congestive heart failure (CHF), utility has not been established for selecting therapy, monitoring response to therapy, or identifying a patient with a high risk of death. 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. 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 lead to decreased cardiac uptake in the absence of heart disease, resulting in a falsely low H/M ratio. When medically feasible, stop these drugs before AdreView administration. Hypertension: AdreView may increase release of norepinephrine from chromaffin granules producing transient hypertension. Individuals With Neurological Diseases That Affect the Sympathetic Nervous System: Imaging in these patients may show decreased cardiac uptake independent of heart disease. 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 with CHF. 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.