Dosing and uses of AdreView (iobenguane I 123)
Adult dosage forms and strengths
IV solution
- 2mCi/mL at calibration time (0.08mg/mL iobenguane sulfate 74 MBq/mL of I 123)
Gamma Scintigraphy
Diagnostic radiopharmaceutical agent for gamma-scintigraphy
Pheochromocytoma or neuroblastoma
- Indicated for detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests
- 10 mCi (5 mL; 370 MBq) IV
- Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration
Congestive heart failure
- Indicated for assessment of myocardial sympathetic innervation in patients with NYHA class 2-3 heart failure with an LVEF <35%; among these patients, may help identify those with lower 1 and 2 year mortality risks as indicated by an H/M ratio ≥1.6
- 10 mCi (5 mL; 370 MBq) IV (2 mCi/mL at calibration time)
- Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration
Administration
Administer IV over 1-2 minutes, then flush with 0.9% NaCl to ensure full dose delivery
Radiation safety
- Emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients
- Minimize bladder exposure by encourage hydration before and after to permit frequent voiding, particularly for the first 48 hr after administration
Thyroid blockade
- Administer potassium iodide oral solution or Lugol’s solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine 123 by the patient’s thyroid
- Individualize according to patient; blockade may not be needed for patients who have undergone thyroidectomy or those with limited life expectancy
Pediatric dosage forms and strengths
IV solution
- 2mCi/mL at calibration time (0.08mg/mL iobenguane sulfate 74 MBq/mL of I 123)
Gamma Scintigraphy
Indicated for detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests, and also for assessment of myocardial sympathetic innervation in patients with NYHA class 2-3 heart failure with an LVEF <35%
Pheochromocytoma or neuroblastoma: Begin whole body planar scintigraphy imaging 24 (± 6 hours) following administration
CHF: Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration
Neonates <1 month: Safety and efficacy not established
<16 yr and ≥70 kg: 10 mCi (5 mL; 370 MBq)
<16 yr (3-18 kg)
- 3 kg: 1 mCi (37 MBq)
- 4 kg: 1.4 mCi (52 MBq)
- 6 kg: 1.9 mCi (70 MBq)
- 8 kg: 2.3 mCi (85.1 MBq)
- 10 kg: 2.7 mCi (99.9 MBq)
- 12 kg: 3.2 mCi (118.4 MBq)
- 14 kg: 3.6 mCi (133.2 MBq)
- 16 kg: 4 mCi (148 MBq)
- 18 kg: 4.4 mCi (162.8 MBq)
<16 yr (20-40 kg)
- 20 kg: 4.6 mCi (170.2 MBq)
- 22 kg: 5 mCi (185 MBq)
- 24 kg: 5.3 mCi (196.1 MBq)
- 26 kg: 5.6 mCi (207.2 MBq)
- 28 kg: 5.8 mCi (214.6 MBq)
- 30 kg: 6.2 mCi (229.4 MBq)
- 32 kg: 6.5 mCi (240.5 MBq)
- 34 kg: 6.8 mCi (251.6 MBq)
- 36 kg: 7.1 mCi (262.7 MBq)
- 38 kg: 7.3 mCi (270.1 MBq)
- 40 kg: 7.6 mCi (281.2 MBq)
<16 yr (42-50 kg)
- 42 kg: 7.8 mCi (288.6 MBq)
- 44 kg: 8 mCi (296 MBq)
- 46 kg: 8.2 mCi (303.4 MBq)
- 48 kg: 8.5 mCi (314.5 MBq)
- 50 kg: 8.8 mCi (325.6 MBq)
<16 yr (52 kg to <70 kg)
- 52-54 kg: 9 mCi (333 MBq)
- 56-58 kg: 9.2 mCi (340.4 MBq)
- 60-62 kg: 9.6 mCi (355.2 MBq)
- 64-66 kg: 9.8 mCi (362.6 MBq)
- 68 kg: 9.9 mCi (366.3 MBq)
Administration
Administer IV over 1-2 minutes, then flush with 0.9% NaCl to ensure full dose delivery
Radiation safety
- Emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients
- Minimize bladder exposure by encourage hydration before and after to permit frequent voiding, particularly for the first 48 hr after administration
Thyroid blockade
- Administer potassium iodide oral solution or Lugol’s solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine 123 by the patient’s thyroid
- Individualize according to patient; blockade may not be needed for patients who have undergone thyroidectomy or those with limited life expectancy
AdreView (iobenguane I 123) adverse (side) effects
Frequency not defined
Dizziness
Rash
Pruritus
Flushing
Injection site hemorrhage
Postmarketing Reports
Hypersensitivity
Warnings
Contraindications
Hypersensitivity
Cautions
Emits radiation and must be handled with appropriate safety measures for radiopharmaceuticals
Fully investigate history of allergic response to previous contrast agents or iodine
Contains benzyl alcohol (10.3 mg/mL); associated with fatal gasping syndrome in premature infants and infants of low birth weight; excessive amounts associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and increased incidence of kernicterus in small preterm infants
Increased radiation exposure in patients with severe renal impairment; cleared by glomerular filtration and is not dialyzable
Failure to block thyroid uptake of iodine 123 may result in increased long-term risk for thyroid neoplasia; administer thyroid blocking medications (see Administration)
Drugs that interfere with norepinephrine uptake or retention may cause false negative imaging results; if clinically feasible, discontinue these drugs before administering iobenguane I 123
Individuals with conditions that affect the sympathetic nervous system (eg, Parkinson disease, multiple system atrophy) may show decreased cardiac uptake of iobenguane I 123 independent of heart disease
Assess pulse and blood pressure before and intermittently for 30 minutes following administration
Pregnancy and lactation
Pregnancy category: C; any radiopharmaceutical may cause fetal harm
Lactation: Unknown whether iobenguane is excreted in human breast milk; however, iodine 123 is excreted into human milk
Decide whether to interrupt nursing after administration not to administer iobenguane I 123, taking into account the importance of the drug to the mother; based on the half-life of iodine 123 (13.2 hr) nursing women may consider interrupting nursing for 6 days after use
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of AdreView (iobenguane I 123)
Mechanism of action
Iobenguane is similar in structure to guanethidine and the neurotransmitter norepinephrine (NE), and is therefore subject to the same uptake and accumulation pathways as Ne
Diagnostic radiopharmaceutical contains only a small quantity of iobenguane that is not expected to produce a pharmacodynamic effect
Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles; accumulates in adrenergically innervated tissues (eg, adrenal medulla, salivary glands, heart, liver, spleen, lungs) as well as tumors derived from the neural crest
Metabolism
Metabolic process not well characterized and pharmacologic activity of metabolites has not been studied
Metabolites: Radioiodinated metabolite m-iodohippuric acid (MIHA); free radioiodide
Elimination
Half-life: 13.2 hr (I 123)
Dialyzable: No
Excretion: 70-90% (unchanged iobenguane) in urine within 4 days
