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%.
General Administration Information
For storage information, see specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Iobenguane I 123 is available in single use vials containing 5 mL solution (2 mCi/mL). Each vial is enclosed in a lead container.
-Prior to administration, assess the patients risk for thyroid accumulation of the drug. In those patients deemed to be at risk, administer either potassium iodide oral solution, Lugol's solution, or potassium perchlorate at least 1 hour before iobenguane I 123 to prevent thyroid uptake of iodine 123. Failure to block accumulation of iodine 123 within the thyroid may increase long term risk for thyroid neoplasia.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
-Use aseptic technique and a radiation shielding syringe during administration.
-Administer as an intravenous injection over 1 to 2 minutes.
-Normal saline flush may be administered after iobenguane I 123 to ensure complete delivery of drug.
-To minimize radiation exposure to the bladder, encourage hydration before and after administration and frequent voiding for 48 hours after administration.
-For pheochromocytoma and neuroblastoma: Obtain whole body planar scintigraphic images 18-30 hours after administration. If appropriate, single photon emission computed tomography (SPECT) may be performed after planar scintigraphy.
-For heart failure: Obtain anterior planar scintigraphic imagines of the chest 4 hours after administration. SPECT may be performed after planar imaging. For all imaging, a low-energy high-resolution collimator is recommended. The recommended matrix for planar images is 128x128. Position the camera to include the entire heart and as much of the upper chest as possible.
Adverse reactions reported in 251 subjects with known or suspected pheochromocytoma or neuroblastoma who were exposed to iobenguane I 123 during clinical development were all mild to moderate in severity and were predominately isolated occurrences (2 subjects 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 subjects 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.
Iobenguane I 123 may cause the release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in clinical studies. Before iobenguane I 123 administration, ensure emergency cardiac and antihypertensive treatments are readily available. Monitor heart rate and blood pressure before and intermittently for 30 minutes after iobenguane I 123 administration.
Failure to block thyroid uptake of iodine 123 may result in an increased long-term risk for new primary malignancy of the thyroid (i.e., thyroid neoplasia).
Iobenguane I 123 is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. Before iobenguane I 123 administration, question the patient for a history of prior reactions to iodine, an iodine-containing contrast agent, or other products containing iodine. If the patient is known or strongly suspected to have hypersensitivity to iodine, an iodine-containing contrast agent, or other products containing iodine, base the decision to administer iobenguane I 123 upon an assessment of the expected benefits compared to the potential hypersensitivity risks. Ensure anaphylactic and hypersensitivity treatment measures are available before iobenguane I 123 administration.
Iobenguane I 123 is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment or renal failure may be increased due to the delayed elimination of the drug. Delayed iobenguane I 123 clearance may also reduce the target to background ratios and decrease the quality of scintigraphic images. These risks may limit the role of iobenguane I 123 in patients with severe renal impairment. Iobenguane I 123 safety and efficacy have not been established in these patients.
Individuals with conditions that affect the sympathetic nervous system, e.g., Parkinsonian syndromes, such as parkinsonism, Parkinson's disease, or multiple system atrophy, may show decreased cardiac uptake of iobenguane I 123 independent of heart disease.
Assess the patient's heart rate and blood pressure before and intermittently for 30 minutes after iobenguane I 123 administration. Iobenguane I 123 may increase release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in the clinical studies. Before iobenguane I 123 administration, ensure emergency cardiac and anti-hypertensive treatments are readily available.
Serious and fatal adverse reactions, including "gasping syndrome", can occur in premature neonates and low birth weight infants treated with benzyl alcohol-preserved drugs, including iobenguane I 123. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Additional adverse reactions include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. When administering iobenguane I 123 to infants, consider the combined daily metabolic load of benzyl alcohol from all sources, including iobenguane I 123 (10.3 mg benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. However, benzyl alcohol doses of 99 to 234 mg/kg/day produced high concentrations of benzyl alcohol and its metabolites in the blood and urine in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative; benzyl alcohol blood concentrations were 0.61 to 1.378 mmol/L.
All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Radioactive iodine crosses the placenta and can permanently impair fetal thyroid function. Administer an appropriate thyroid blocking agent before use of iobenguane I 123 in pregnant women to protect the woman and fetus from accumulation of I 123. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of iobenguane I 123. Iobenguane I 123 contains 10.3 mg/mL of benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. There are no data available on iobenguane I 123 use during human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with iobenguane I 123.
Iodine 123, the radionuclide in iobenguane I 123, is excreted in human breast milk. There is no information on the effects on the breast-fed infant or on milk production. Advise a lactating woman to interrupt breast-feeding and pump and discard breast milk for at least 6 days (more than 10 half-lives) after iobenguane I 123 administration in order to minimize radiation exposure to a breast-fed infant.
Iobenguane I 123 is associated with reproductive risk. Assess pregnancy status with pregnancy testing before administering iobenguane I 123 to a woman of reproductive potential.
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.
For use in primary or metastatic neuroblastoma or pheochromocytoma diagnosis in addition to other tests:
Intravenous dosage:
Adults and Adolescents >= 16 years of age or weighing >= 70kg: 10 mCi (370 MBq) IV over 1 to 2 minutes. A subsequent injection of normal saline may be used to ensure total delivery of dose. To block thyroid uptake of iodine 123, administer potassium iodide oral solution or Lugol's solution (100 mg iodide) or potassium perchlorate (400 mg) at least 1 hour prior to the administration of iobenguane I 123. Obtain whole body planar scintigraphy 18 to 30 hours after iobenguane I 123 administration.
Infants >= 1 month, Children, and Adolescents < 16 years or < 70 kg: Administer weight-based dose IV over 1 to 2 minutes. A subsequent injection of normal saline may be used to ensure total delivery of dose. To block thyroid uptake of iodine 123, administer potassium iodide oral solution or Lugol's solution or potassium perchlorate at least 1 hour prior to the administration of iobenguane I 123. Obtain whole body planar scintigraphy imaging 18 to 30 hours after iobenguane I 123 administration. Determine the individual dose based on the following patient weights:
68 kg: 9.9 mCi (366.3 MBq)
66 kg: 9.8 mCi (362.6 MBq)
64 kg: 9.8 mCi (362.6 MBq)
62 kg: 9.6 mCi (355.2 MBq)
60 kg: 9.6 mCi (355.2 MBq)
58 kg: 9.2 mCi (340.4 MBq)
56 kg: 9.2 mCi (340.4 MBq)
54 kg: 9 mCi (333 MBq)
52 kg: 9 mCi (333 MBq)
50 kg: 8.8 mCi (325.6 MBq)
48 kg: 8.5 mCi (314.5 MBq)
46 kg: 8.2 mCi (303.4 MBq)
44 kg: 8 mCi (296 MBq)
42 kg: 7.8 mCi (288.6 MBq)
40 kg: 7.6 mCi (281.2 MBq)
38 kg: 7.3 mCi (273.1 MBq)
36 kg: 7.1 mCi (262.7 MBq)
34 kg: 6.8 mCi (251.6 MBq)
32 kg: 6.5 mCi (240.5 MBq)
30 kg: 6.2 mCi (229.4 MBq)
28 kg: 5.8 mCi (214.6 MBq)
26 kg: 5.6 mCi (207.2 MBq)
24 kg: 5.3 mCi (196.1 MBq)
22 kg: 5 mCi (185 MBq)
20 kg: 4.6 mCi (170.2 MBq)
18 kg: 4.4 mCi (162.8 MBq)
16 kg: 4 mCi (148 MBq)
14 kg: 3.6 mCi (133.2 MBq)
12 kg: 3.2 mCi (118.4 MBq)
10 kg: 2.7 mCi (99.9 MBq)
8 kg: 2.3 mCi (85.1 MBq)
6 kg: 1.9 mCi (70 MBq)
4 kg: 1.4 mCi (52 MBq)
3 kg: 1 mCi (37 MBq)
Neonates: Safety and efficacy have not been established.
For scintigraphic assessment of sympathetic innervation of the myocardium and assessment of mortality risks in heart failure (NYHA class II or class III and left ventricular ejection fraction 35% or less) by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake:
Intravenous dosage:
Adults: 10 mCi (370 MBq) IV as a single dose. Obtain anterior planar scintigraphic images of the chest 4 hours after administration. Single photon emission computed tomography (SPECT) can then be performed. A heart to mediastinum (H/M) radioactive uptake ratio of 1.6 or more indicates lower 1 and 2 year mortality risks. Use of iobenguane I 123 has not been established for selecting therapeutic interventions, monitoring response to therapy, or identifying persons with high risk for death.
Maximum Dosage Limits:
-Adults
10 mCi (370 MBq).
-Elderly
10 mCi (370 MBq).
-Adolescents
>= 16 years or >= 70 kg: 10 mCi (370 MBq).
< 16 years and < 70 kg: Dose calculated according to patient body weight.
-Children
Dose calculated according to patient body weight.
-Infants
Dose calculated according to patient body weight.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; however, it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Safety and efficacy have not been established in patients with severe renal impairment. Iobenguane I 123 is eliminated via glomerular filtration; radiation exposure may be increased in patients with severe renal impairment due to delayed elimination of the drug. Scintigraphic image quality may also suffer as delayed iobenguane I 123 clearance may reduce the target to background ratios. Iobenguane I 123 is not dialyzable.
*non-FDA-approved indication
Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Chlorpheniramine; Phenylephrine : (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Dextromethorphan; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Dextromethorphan; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Guaifenesin; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acetaminophen; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Acrivastine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Amitriptyline: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Brompheniramine; Dextromethorphan; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Brompheniramine; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Brompheniramine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Brompheniramine; Pseudoephedrine; Dextromethorphan: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Cetirizine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlophedianol; Dexchlorpheniramine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlordiazepoxide; Amitriptyline: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlorpheniramine; Dextromethorphan; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlorpheniramine; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Chlorpheniramine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Citalopram: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Clomipramine: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Cocaine: (Major) Discontinue medications that decrease norepinephrine uptake, such as cocaine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating cocaine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Codeine; Guaifenesin; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Codeine; Phenylephrine; Promethazine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Desipramine: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Desloratadine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Dexbrompheniramine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Dextromethorphan; Diphenhydramine; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Dextromethorphan; Guaifenesin; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Dextromethorphan; Guaifenesin; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Diphenhydramine; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Doxepin: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Ephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as ephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating ephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Ephedrine; Guaifenesin: (Major) Discontinue medications that decrease norepinephrine uptake, such as ephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating ephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Escitalopram: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Fexofenadine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Fluoxetine: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Fluvoxamine: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Guaifenesin; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Guaifenesin; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Ibuprofen; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Imipramine: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Labetalol: (Major) Discontinue medications that decrease norepinephrine uptake, such as labetalol, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating labetalol withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Loratadine; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Naproxen; Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Nortriptyline: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Olanzapine; Fluoxetine: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Paroxetine: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Perphenazine; Amitriptyline: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Promethazine; Phenylephrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as phenylephrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating phenylephrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Protriptyline: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Pseudoephedrine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Pseudoephedrine; Triprolidine: (Major) Discontinue medications that decrease norepinephrine uptake, such as pseudoephedrine, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating pseudoephedrine withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Selective serotonin reuptake inhibitors: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Sertraline: (Major) Discontinue medications that decrease norepinephrine uptake, such as selective serotonin reuptake inhibitors (SSRIs), for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating SSRI withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Tricyclic antidepressants: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Trimipramine: (Major) Discontinue medications that decrease norepinephrine uptake, such as tricyclic antidepressants, for at least 5 biological half-lives prior to iobenguane I 123 administration. Consider medication tapering or additional supportive therapy as appropriate to minimize the risk for precipitating tricyclic antidepressant withdrawal symptoms. Medications that decrease the uptake of norepinephrine can cause false negative imaging results. Increasing the dose of iobenguane I 123 will not overcome any potential uptake limiting effect of this medication.
Iobenguane I 123 is a diagnostic radiopharmaceutical administered via intravenous injection. Iobenguane is structurally similar to norepinephrine and undergoes a similar uptake and accumulation pathway. Iobenguane is taken up by the norepinephrine transporter on adrenergic nerve terminals. As a result, iobenguane accumulates in tissues that have high adrenergic innervation such as the adrenal medulla, heart, salivary glands, liver, spleen, and lungs. Iobenguane is also taken up by tumors that are derived from the neural crest. Iobenguane I 123 is labeled with the isotope iodine 123, a gamma-radiation emitter. The addition of iodine 123 to iobenguane makes it possible to obtain scintigraphic images of the organs and tissues where the radiopharmaceutical has accumulated.
Iobenguane I 123 is administered as an intravenous injection. After administration, iobenguane I 123 is rapidly cleared from the blood stream and accumulates in adrenergically innervated tissues. Iobenguane I 123 retention is prolonged in tissues that are highly adrenergically innervated (e.g., heart, salivary glands, adrenal medulla). Iobenguane I 123 is a diagnostic radiopharmaceutical agent that contains a small amount of iobenguane (0.08 mg/mL) and is not expected to produce a pharmacodynamic effect related to iobenguane. The thyroid gland should be blocked prior to administration to reduce the amount of drug uptake and radiation exposure to this organ.
Iobenguane I 123 is excreted unchanged in the urine via glomerular filtration. Circulating iobenguane is cleared rapidly by the kidneys. Iobenguane in tissues is cleared more slowly as it is released back into the bloodstream. After administration, 70-90% of iobenguane is recovered unchanged in the urine within 4 days. The majority of remaining radioactivity recovered in the urine is in the form of the radioiodinated metabolite m-iodohippuric acid (MIHA) and free radioiodide. The enzymatic metabolism and pharmacologic activity of these metabolites is unclear. Iodine 123 decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.
-Special Populations
Renal Impairment
Iobenguane is primarily excreted unchanged via glomerular filtration. Patients with severe renal impairment may have an increased radiation exposure and impaired imaging results. Iobenguane I 123 is not dialyzable.