Version May 2024
Note: Thyroid protective agents (eg, Lugol solution, potassium iodide), should be given at least 1 hour prior to administration (in patients at risk for accumulation in thyroid).
Radioimaging: IV: 10 mCi (370 MBq).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, radiation exposure may be increased in patients with severe renal impairment; use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Note: Thyroid protective agents (eg, Lugol solution, potassium iodide), should be given at least 1 hour prior to administration (in patients at risk for accumulation in thyroid).
Radioimaging: Pheochromocytoma and neuroblastoma: IV:
Children 1 month to 16 years and <70 kg: Dose according to body weight; see table.
Children <16 years and ≥70 kg: 10 mCi (370 MBq).
Children ≥16 years: Refer to adult dosing.
|
Weight (kg) |
mCi Dose |
MBq Dose |
|---|---|---|
|
3 |
1 |
37 |
|
4 |
1.4 |
52 |
|
6 |
1.9 |
70 |
|
8 |
2.3 |
85.1 |
|
10 |
2.7 |
99.9 |
|
12 |
3.2 |
118.4 |
|
14 |
3.6 |
133.2 |
|
16 |
4 |
148 |
|
18 |
4.4 |
162.8 |
|
20 |
4.6 |
170.2 |
|
22 |
5 |
185 |
|
24 |
5.3 |
196.1 |
|
26 |
5.6 |
207.2 |
|
28 |
5.8 |
214.6 |
|
30 |
6.2 |
229.4 |
|
32 |
6.5 |
240.5 |
|
34 |
6.8 |
251.6 |
|
36 |
7.1 |
262.7 |
|
38 |
7.3 |
270.1 |
|
40 |
7.6 |
281.2 |
|
42 |
7.8 |
288.6 |
|
44 |
8 |
296 |
|
46 |
8.2 |
303.4 |
|
48 |
8.5 |
314.5 |
|
50 |
8.8 |
325.6 |
|
52-54 |
9 |
333 |
|
56-58 |
9.2 |
340.4 |
|
60-62 |
9.6 |
355.2 |
|
64-66 |
9.8 |
362.6 |
|
68 |
9.9 |
366.3 |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, radiation exposure may be increased in patients with severe renal impairment; use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Local: Injection site reaction (hematoma/bruising: 1%)
<1%, postmarketing, and/or case reports: Bleeding at injection site, dizziness, flushing, headache, hypersensitivity (rare), hypertension (transient), pruritus, skin rash
Hypersensitivity to iobenguane, iobenguane sulfate, or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions have been reported. Use with extreme caution in patients with iodine or iodine-contrast agent hypersensitivity (base treatment decision on assessment of benefit versus risk). Appropriate equipment and emergency medications should be available during use.
Disease-related concerns:
• Heart failure: Use has not been evaluated for selecting therapeutic intervention or monitoring treatment response; the H/M ratio has not been used in identifying patients with a higher mortality risk. Patients were excluded from clinical studies if the risks of withdrawing interacting cardiovascular medications outweighed the potential value of imaging.
• Hypertension: May cause a transient increase in blood pressure (although not observed in clinical trials). Monitor blood pressure prior to administration and intermittently for 30 minutes following administration. Appropriate emergency cardiac and antihypertensive treatments should be available during use.
• Renal impairment: Use with caution in patients with severe renal impairment; safety and efficacy have not been established. Patients with severe renal impairment may have delayed elimination, therefore, increasing the radiation dose and decreasing quality of images. Not dialyzable.
• Sympathetic nervous system disorders: Patients with sympathetic nervous system disorders (eg, Parkinson's disease or multiple system atrophy) may have reduced cardiac uptake of iobenguane; may result in imaging errors (eg, false negatives).
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Administer thyroid blocking medications (eg, potassium iodide oral solution, potassium perchlorate) at least 1 hour prior to administration (in patients at risk for accumulation in thyroid); long-term risk for thyroid neoplasia can occur from failure to block thyroid uptake of iodine 123. Thyroid blockade is not necessary for thyroidectomy patients and may not be necessary in patients with a short life-expectancy. Patients should be adequately hydrated prior to dosing; instruct patients to void frequently for 48 hours following administration to decrease radiation exposure.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution:
AdreView: Iobenguane sulfate 0.08 mg and I 123 74 MBq (2 mCi) per mL (1 ea) [contains benzyl alcohol]
No
Solution (AdreView Intravenous)
10 mci/5 mL (per each): $5,838.18
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer intravenously over 1 to 2 minutes. May flush with NS to ensure full delivery of dose. Prior to administration, a thyroid-protective agent should be administered (in patients at risk for accumulation in thyroid). Ensure adequate hydration before and after treatment; instruct patient to void frequently for 48 hours after administration to minimize bladder exposure.
Heart failure: Begin anterior planar chest imaging 4 hours (±10 minutes) following administration; single photon emission computed tomography (SPECT) may then be performed. Low-energy high-resolution is the recommended imaging collimator; the recommended matrix for planar images is 128 x 128; position camera to include entire heart and as much of upper chest as possible within field. Follow details within manufacturer’s labeling to determine heart to mediastinum (H/M) ratio.
Pheochromocytoma and neuroblastoma: Perform whole body planar scintigraphy imaging 18 to 30 hours after iobenguane I 123 administration; SPECT may be performed following planar scintigraphy (as appropriate).
Radiopharmaceutical; use appropriate precautions for handling and disposal.
Radiopharmaceutical; use appropriate precautions for handling and disposal.
IV: Administer IV over 1 to 2 minutes. May flush with NS to ensure full delivery of dose. Prior to administration, a thyroid-protective agent should be administered at least 1 hour prior to iobenguane I 123 dose (in patients at risk for accumulation in thyroid). Ensure adequate hydration before and after treatment; instruct patient to void frequently for 48 hours after administration to minimize bladder exposure.
Pheochromocytoma and neuroblastoma: Perform whole body planar scintigraphy imaging 18 to 30 hours after iobenguane I 123 administration; SPECT may be performed following planar scintigraphy (as appropriate).
Radioimaging: As an adjunct to other diagnostic tests, in the detection of primary or metastatic pheochromocytoma or neuroblastoma; scintigraphic assessment of sympathetic myocardium innervation (by measurement of heart to mediastinum [H/M] ratio of radioactivity uptake) in patients with New York Heart Association class II or class III heart failure and LVEF ≤35% (may help identify lower 1 and 2 year mortality risks, indicated by H/M ratio ≥1.6)
Limitations of use: Congestive heart failure patients: Use has not been established for selecting a therapeutic intervention, monitoring therapeutic response, or identifying patients with a high risk of death by using the H/M ratio.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpha-/Beta-Agonists (Indirect-Acting): May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Alpha1-Agonists: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Amphetamines: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
BuPROPion: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer bupropion until at least 7 days after each iobenguane dose. Risk X: Avoid combination
CNS Stimulants: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Cocaine (Topical): May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer cocaine until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Guanethidine: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer guanethidine until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Labetalol: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer labetalol until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Maprotiline: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer maprotiline until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Methyldopa: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer methyldopa until at least 7 days after each iobenguane dose. Risk X: Avoid combination
MetyroSINE: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer metyrosine until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Monoamine Oxidase Inhibitors: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Reserpine: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer reserpine until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Selective Norepinephrine Reuptake Inhibitors: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
St John's Wort: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer St John's wort until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Tapentadol: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer tapentadol until at least 7 days after each iobenguane dose. Risk X: Avoid combination
TraMADol: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer tramadol until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Tricyclic Antidepressants: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Yohimbine: May diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer yohimbine until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Evaluate pregnancy status prior to use in females of reproductive potential.
Radioactive iodine crosses the placenta.
In utero exposure to radioactive iodine may permanently impair fetal thyroid function. If use is needed during pregnancy an appropriate thyroid blocking agent is recommended to protect the mother and fetus from accumulation of I 123.
Iodine 123 is present in breast milk.
The manufacturer recommends interrupting breastfeeding (express and discard milk) for 6 days after administration of iobenguane I 123 to minimize risk to the breastfed infant. Recommendations for breastfeeding following exposure vary from no interruption to up to 3 weeks following thyroid imaging (ABM [Mitchell 2018]). Interruption of breastfeeding for >3 weeks following neuroblastoma imaging is also recommended (IAEA 2018). Consider evaluating radioactivity in breast milk prior to resumption of breastfeeding (ABM [Mitchell 2018]).
Some dietary sources of iodine include cow's milk and dairy products, fish, seaweed, eggs, chocolate, and iodized salt.
TSH, prior to therapy and every six months for life (Hamnvik 2011). Pulse and blood pressure prior to administration and intermittently for 30 minutes following; monitor for hypersensitivity reaction. Evaluate pregnancy status prior to use in females of reproductive potential.
Iobenguane is structurally similar to norepinephrine and therefore is taken up and stored in adrenergic tissue such as adrenal medulla, heart, liver, lungs, salivary glands, and spleen. Iobenguane is bound to radioactive iodine in order to obtain organ and tissue images.
Distribution: Increased in adrenergically innervated tissues (eg, heart, salivary glands, adrenal medulla)
Metabolism: Has not been characterized
Half-life elimination: Iodine 123: 13.2 hours
Excretion: Urine (70 % to 90%) within 4 days (normal renal function); feces <1%
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