Iobenguane i-123

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 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.

Iobenguane is similar in structure to the antihypertensive drug guanethedine and to the neurotransmitter norepinephrine (NE). Iobenguane is, therefore, largely subject to the same uptake and accumulation pathways as NE. Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles. Iobenguane accumulates in adrenergically innervated tissues such as the adrenal medulla, salivary glands, heart, liver, spleen and lungs as well as tumors derived from the neural crest. By labeling iobenguane with the isotope iodine 123, it is possible to obtain scintigraphic images of the organs and tissues in which the radiopharmaceutical accumulates.

AdreView emits radiation and must be handled with appropriate safety measures. Administer thyroid blockade medications to patients at risk for thyroid accumulation of AdreView. Measure patient dose by a suitable radioactivity calibration system immediately prior to administration. For patients ≥ 16 years of age or < 16 years of age and ≥ 70 kg: administer 10 mCi (370 MBq). For patients < 16 years of age and < 70 kg: amount scaled to the adult reference activity based on weight.

AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. Known hypersensitivity to iobenguane or iobenguane sulfate.

Hypersensitivity reactions have followed AdreView administration. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration. Drugs which block norepinephrine uptake or deplete norepinephrine stores may decrease AdreView uptake. When medically feasible, stop these drugs before AdreView administration and monitor patients for withdrawal signs and symptoms. AdreView contains benzyl alcohol (10.3 mg/mL) which may cause serious reactions in premature or low birth-weight infants. Patients with severe renal impairment may have increased radiation exposure and decreased quality of AdreView images. Failure to block thyroid iodine uptake may result in iodine 123 accumulation in the thyroid.

Serious hypersensitivity reactions have been reported following AdreView administration. The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients.

The following drugs have the potential to decrease the uptake of norepinephrine and cause false negative imaging results: antihypertensives that deplete norepinephrine stores or inhibit reuptake (e.g., reserpine, labetalol), antidepressants that inhibit norepinephrine transporter function (e.g., amitriptyline and derivatives, imipramine and derivatives, selective serotonin reuptake inhibitors), sympathomimetic amines (e.g., phenylephrine, phenylpropanolamine, pseudoephedrine and ephedrine), and cocaine. Clinical studies have not determined which specific drugs may cause false negative imaging results nor whether all drugs in any specific pharmacologic class have the same potential to produce the negative imaging results. Increasing the dose of AdreView will not overcome any potential uptake limiting effect of these drugs.

Store AdreView at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F). Store within the original lead container or equivalent radiation shielding.