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What is Iobenguane I 123
Iobenguane I 123 for injection (AdreView) is a radiopharmaceutical diagnostic agent used in the diagnosis of pheochromocytoma or neuroblastoma.
The drug is also indicated for use in patients with New York Heart Association (NYHA) class II/III heart failure and left ventricular ejection fraction (LVEF) <= 35% to help identify lower 1 and 2 year mortality risks.
Iobenguane is taken up into adrenergically innervated tissues in a similar fashion as norepinephrine.
The addition of the isotope iodine 123 allows gamma-scintigraphic images to be obtained in tissues where iobenguane I 123 has accumulated. Iodine 123 emits gamma radiation only.
In December 2008, iobenguane I 123 received FDA approval for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
In March 2013, the FDA approved its use to help identify lower 1 and 2 year mortality risks in patients with class II/III heart failure and LVEF <= 35%.
Indications
- assessment of mortality risks in heart failure
- neuroblastoma
- pheochromocytoma diagnosis
NOTE: Iobenguane I 123 emits radiation and should be handled with appropriate safety measures to minimize radiation exposure to personnel and patients. Radiopharmaceuticals should only be used by or under the control of physicians who are qualified by training and experience in the safe use and handling of radionuclides.
Side Effects
During clinical development, 251 patients with known or suspected pheochromocytoma or neuroblastoma were exposed to iobenguane I 123.
Adverse reactions were all mild to moderate in severity and were predominately isolated occurrences (2 patients or less) of dizziness, rash, pruritus, flushing, or injection site reaction (i.e., hemorrhage). Injection site hematoma or bruising (1.3%), headache (0.4%), and flushing (0.3%) were reported in patients with heart failure (n = 985) given iobenguane I 123 in clinical studies.
Hypersensitivity or anaphylactoid reactions have been uncommonly reported during the postmarketing use of iobenguane I 123. Ensure anaphylactic and hypersensitivity treatment measures are readily available before administration of iobenguane I 123.
Monitoring Parameters
- pregnancy testing
- serum creatinine
Contraindications
- breast-feeding
- hypertension
- infants
- neonates
- Parkinson’s disease
- parkinsonism
- pregnancy
- pregnancy testing
- premature neonates
- renal failure
- renal impairment
- reproductive risk
Interactions
No information is available regarding drug interactions associated with Iobenguane I 123
