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Adreview Generic Name & Formulations
Legal Class
Rx
General Description
Iobenguane I 123 74MBq/mL (2mCi/mL); soln for IV inj; contains benzyl alcohol.
Pharmacological Class
Radioactive diagnostic agent.
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Adreview Indications
Indications
As adjunct to other diagnostic tests, for the detection of primary or metastatic pheochromocytoma or neuroblastoma. 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 NYHA class II or
class III heart failure and left ventricular ejection fraction (LVEF) ≤35%.
Limitations of Use
In CHF patients: not established for selecting a therapeutic intervention or for monitoring response to therapy. Not established for using the H/M ratio to identify a patient with high mortality risk.
Adreview Dosage and Administration
Adults and Children
Administer thyroid blockade medications at least 1hr prior to dose; individualize. Give by IV inj over 1–2mins. <16yrs (<70kg): calculate dose based on body weight (see full labeling); (≥70kg): 10mCi (370MBq). ≥16yrs: 10mCi (370MBq).
Adreview Contraindications
Not Applicable
Adreview Boxed Warnings
Not Applicable
Adreview Warnings/Precautions
Warnings/Precautions
Should only be used by trained and experienced physicians in the safe use and handling of radionuclides to minimize radiation exposure. Ensure adequate hydration; encourage frequent voiding for first 48hrs post-administration. Allergy to iodine. Conditions that affect the sympathetic nervous system (eg, Parkinson's disease, multiple system atrophy): risk of imaging errors. Increased risk for thyroid neoplasia without use of blocking agents. Monitor pulse, BP prior to and intermittently for 30mins post-administration. Have resuscitation equipment/medications readily available. Severe renal impairment. Neonates/infants: monitor for gasping syndrome. Elderly: assess renal function prior to administration. Pregnancy. Nursing mothers: interrupt and pump/discard breastmilk for at least 6 days after administration.
Adreview Pharmacokinetics
See Literature
Adreview Interactions
Interactions
Risk of imaging errors with concomitant antihypertensives that deplete norepinephrine stores or inhibit reuptake (eg, reserpine, labetalol), antidepressants that inhibit norepinephrine transfer function (eg, amitriptyline and derivatives, imipramine and derivatives, SSRIs), sympathomimetic amines (eg, phenylephrine, phenylpropanolamine, pseudoephedrine, ephedrine), cocaine; discontinue for at least 5 half-lives prior to administration if medically feasible and monitor.
Adreview Adverse Reactions
Adverse Reactions
Dizziness, rash, pruritus, flushing, headache, inj site hemorrhage; hypersensitivity reactions.
Adreview Clinical Trials
See Literature
Adreview Note
Not Applicable
Adreview Patient Counseling
See Literature
