AdreView (Iobenguane I 123 Injection for Intravenous Use)
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AdreView (Iobenguane I 123 Injection for Intravenous Use)

AdreView
(iobenguane I 123) Injection for Intravenous Use

DRUG DESCRIPTION

AdreView (iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

AdreView
  (iobenguane I 123) Structural Formula Illustration

Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3: Principal Radiation Emission Data – Iodine 123

Radiation Energy Level (keV) Abundance (%)
Gamma 159 83

External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4: Reduction in In-air Collision Kerma Caused by Lead Shielding*

Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4
*Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632

What are the possible side effects of iobenguane I-123 (AdreView)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • dizziness;
  • mild skin rash or itching;
  • bleeding around your IV needle; or
  • warmth, tingling, or cold feeling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of AdreView »

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

AdreView (iobenguane i 123 injection for intravenous use) is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

DOSAGE AND ADMINISTRATION

Radiation Safety

AdreView (iobenguane i 123 injection for intravenous use) emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. AdreView (iobenguane i 123 injection for intravenous use) dosing is based upon the radioactivity determined using a suitable calibration system immediately prior to administration.

To minimize radiation dose to the bladder, prior to and following AdreView (iobenguane i 123 injection for intravenous use) administration, encourage hydration to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following AdreView administration [see CLINICAL PHARMACOLOGY].

Thyroid Blockade

Before administration of AdreView (iobenguane i 123 injection for intravenous use) , 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. Administer the blocking agent at least one hour before the dose of AdreView [see WARNINGS AND PRECAUTIONS].

Preparation and Administration

Inspect the AdreView (iobenguane i 123 injection for intravenous use) vial for particulate matter and discoloration prior to administration. Use aseptic procedures and a radiation shielding syringe during administration. Administer the dose as an intravenous injection over 1 to 2 minutes. A subsequent injection of 0.9% sodium chloride may be used to ensure full delivery of the dose.

Recommended Dose for Adults

For adults ( ≥ 16 years of age), the recommended dose is 10 mCi (370 MBq) [see Clinical Studies].

Recommended Dose for Pediatric Patients

For pediatric patients < 16 years of age weighing ≥ 70 kg, the recommended dose is 10 mCi (370 MBq) [see Clinical Studies].

For pediatric patients < 16 years of age weighing < 70 kg, the recommended dose should be calculated according to patient body weight as shown in Table 1 [see Clinical Studies]. The benzyl alcohol in AdreView (iobenguane i 123 injection for intravenous use) may cause serious adverse reactions in premature or low birth-weight infants [see WARNINGS AND PRECAUTIONS].

Table 1: AdreView (iobenguane i 123 injection for intravenous use) Dose Preparation for Pediatric Patients*

Weight (kg) Fraction of adult activity AdreView (mCi) pediatric dose AdreView (MBq) pediatric dose
3 0.1 1 37
4 0.14 1.4 52
6 0.19 1.9 70
8 0.23 2.3 85.1
10 0.27 2.7 99.9
12 0.32 3.2 118.4
14 0.36 3.6 133.2
16 0.4 4 148
18 0.44 4.4 162.8
20 0.46 4.6 170.2
22 0.5 5 185
24 0.53 5.3 196.1
26 0.56 5.6 207.2
28 0.58 5.8 214.6
30 0.62 6.2 229.4
32 0.65 6.5 240.5
34 0.68 6.8 251.6
36 0.71 7.1 262.7
38 0.73 7.3 270.1
40 0.76 7.6 281.2
42 0.78 7.8 288.6
44 0.8 8 296
46 0.82 8.2 303.4
48 0.85 8.5 314.5
50 0.88 8.8 325.6
52 0.9 9 333
54 0.9 9 333
56 0.92 9.2 340.4
58 0.92 9.2 340.4
60 0.96 9.6 355.2
62 0.96 9.6 355.2
64 0.98 9.8 362.6
66 0.98 9.8 362.6
68 0.99 9.9 366.3
*Based on a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine Paediatric Task Group.

Radiation Dosimetry

The estimated absorbed radiation doses to adults and children from intravenous administration of AdreView (iobenguane i 123 injection for intravenous use) are as shown in Table 2:

Table 2: Estimated Absorbed Radiation Dose from AdreView (iobenguane i 123 injection for intravenous use)

ORGAN/TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY
ADULT 15-YEAR OLD 10-YEAR OLD 5-YEAR OLD 1-YEAR OLD NEONATES
µGy/ MBq rad/mCi µGy/ MBq rad/mCi µGy/ MBq rad/mCi µGy/ MBq rad/mCi µGy/ MBq rad/mCi µGy/ MBq rad/mCi
Adrenals 16 0.059 21 0.078 31 0.115 42 0.155 67 0.248 111 0.411
Brain 3.9 0.014 4.9 0.018 8.1 0.030 13 0.048 24 0.089 55.9 0.207
Breast 4.7 0.017 5.9 0.022 9.4 0.035 15 0.056 28 0.104 65.3 0.242
Gallbladder 20 0.074 24 0.089 34 0.126 51 0.189 95 0.352 200 0.740
GI Tract Stomach Wall 7.6 0.028 10 0.037 17 0.063 27 0.100 51 0.189 114 0.422
Small Intestine Wall 7.7 0.028 9.8 0.036 16 0.059 25 0.093 46 0.170 104 0.385
Colon Wall 8.1 0.030 10 0.037 16 0.059 26 0.096 46 0.170 104.3 0.386
Upper Large Intestine Wall 8.4 0.031 11 0.041 18 0.067 30 0.111 53 0.196 119 0.440
Lower Large Intestine Wall 7.7 0.028 9.6 0.036 15 0.056 21 0.078 38 0.141 84.9 0.314
Heart Wall 18 0.067 23 0.085 35 0.130 53 0.196 94 0.348 182 0.673
Kidneys 13 0.048 16 0.059 24 0.089 35 0.130 59 0.218 132 0.488
Liver 67 0.248 87 0.322 130 0.481 180 0.666 330 1.221 720 2.664
Lungs 16 0.059 23 0.085 32 0.118 48 0.178 89 0.329 215 0.796
Muscles 6 0.022 7.6 0.028 12 0.044 17 0.063 33 0.122 75.1 0.278
Esophagus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267
Osteogenic Cells 16 0.059 21 0.078 31 0.115 47 0.174 100 0.370 254 0.940
Ovaries 7.9 0.029 10 0.037 15 0.056 22 0.081 41 0.152 92.3 0.342
Pancreas 12 0.044 15 0.056 25 0.093 39 0.144 68 0.252 143 0.529
Red marrow 5.6 0.021 6.8 0.025 10 0.037 15 0.056 30 0.111 89.5 0.331
Skin 3.7 0.014 4.4 0.016 7.1 0.026 11 0.041 21 0.078 53.1 0.196
Spleen 20 0.074 27 0.100 42 0.155 64 0.237 110 0.407 282 1.043
Testes 5.4 0.020 7.1 0.026 11 0.041 16 0.059 30 0.111 69.9 0.259
Thymus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267
Thyroid 4.7 0.017 6.1 0.023 9.9 0.037 16 0.059 30 0.111 69.4 0.257
Urinary Bladder Wall 66 0.244 84 0.311 110 0.407 110 0.407 200 0.740 478.0 1.769
Uterus 11 0.041 14 0.052 21 0.078 28 0.104 51 0.189 110.0 0.407
Whole Body 8.1 0.030 10 0.037 16 0.059 24 0.089 44 0.163 104.0 0.385
EFFECTIVE DOSE µSv/MBq 13.7 18.1 26.7 37.6 68 162
mSv/mCi 0.507 0.670 0.988 1.39 2.52 6
*OLINDA/EXM calculation based on biodistribution data from Swanson et al. and Publication 53 of the ICRP (International Commission on Radiological Protection) [Annals of the ICRP 1987; 18 (1-4): 329-331]

The effective dose resulting from an administered activity amount of 10 mCi is 5.07 mSv in an adult.

Imaging Guidelines

Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration of AdreView (iobenguane i 123 injection for intravenous use) . Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate [see Clinical studies].

HOW SUPPLIED

Dosage Forms And Strengths

Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).

AdreView (iobenguane i 123 injection for intravenous use) is supplied in 10 mL glass vials containing a total volume of 5.0 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of appropriate thickness.

NDC 17156-235-01

Storage

Store AdreView (iobenguane i 123 injection for intravenous use) at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. This product does not contain a preservative. Store within the original lead container or equivalent radiation shielding.

In accordance with USP recommendations Iobenguane I 123 Injection preparations should not be used after the expiration date and time stated on the label.

Handling

This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Adm. Code Section 330.260(a) and 355.4010 or equivalent licenses of the Nuclear Regulatory Commission or an Agreement State.

Manufactured and Distributed by GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL 60004 U.S.A.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Study Experience

Serious adverse reactions were not observed in the AdreView (iobenguane i 123 injection for intravenous use) clinical study. The data described below reflect AdreView (iobenguane i 123 injection for intravenous use) exposure to 251 patients with known or suspected pheochromocytoma or neuroblastoma. The average ages were 49 years (range 17 – 88 years) for adults and, for pediatric patients, 4 years (range 1 month - 16 years). Slightly less than half the patients were male. All patients were monitored for adverse reactions over a 24 hour period following AdreView (iobenguane i 123 injection for intravenous use) administration.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions were all mild to moderate in severity and were predominantly isolated occurrences ( ≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage.

Postmarketing Experience

Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions have uncommonly been reported during the postmarketing use of AdreView [see WARNINGS AND PRECAUTIONS].

Read the AdreView (iobenguane i 123 injection for intravenous use) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

The following drugs have the potential to decrease the uptake of norepinephrine and cause false negative imaging results: antihypertensives that deplete norepinephrine stores or inhibit reuptake (e.g., reserpine, labetalol), antidepressants that inhibit norepinephrine transporter function (e.g., amitriptyline and derivatives, imipramine and derivatives, selective serotonin reuptake inhibitors), sympathomimetic amines (e.g., phenylephrine, phenylpropanolamine, pseudoephedrine and ephedrine), and cocaine. Clinical studies have not determined which specific drugs may cause false negative imaging results nor whether all drugs in any specific pharmacologic class have the same potential to produce the negative imaging results. Increasing the dose of AdreView (iobenguane i 123 injection for intravenous use) will not overcome any potential uptake limiting effect of these drugs. Before AdreView (iobenguane i 123 injection for intravenous use) administration, discontinue (for at least 5 biological half-lives) drugs known or expected to reduce norepinephrine uptake, as clinically tolerated.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions have been reported following AdreView (iobenguane i 123 injection for intravenous use) administration. Prior to 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, the decision to administer AdreView (iobenguane i 123 injection for intravenous use) should be based upon an assessment of the expected benefits compared to the potential hypersensitivity risks. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration [see ADVERSE REACTIONS].

Risks for Benzyl Alcohol Toxicity in Infants

AdreView (iobenguane i 123 injection for intravenous use) contains benzyl alcohol at a concentration of 10.3 mg/mL. Benzyl alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. [see DESCRIPTION].

Observe infants for signs or symptoms of benzyl alcohol toxicity following AdreView (iobenguane i 123 injection for intravenous use) administration. AdreView (iobenguane i 123 injection for intravenous use) safety and effectiveness have not been established in neonates (pediatric patients below the age of 1 month).

Increased Radiation Exposure in Patients with Severe Renal Impairment

AdreView (iobenguane i 123 injection for intravenous use) is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment may be increased due to the delayed elimination of the drug. Delayed AdreView (iobenguane i 123 injection for intravenous use) clearance may also reduce the target to background ratios and decrease the quality of scintigraphic images. These risks importantly may limit the role of AdreView (iobenguane i 123 injection for intravenous use) in the diagnostic evaluation of patients with severe renal impairment. AdreView (iobenguane i 123 injection for intravenous use) safety and efficacy have not been established in these patients [see CLINICAL PHARMACOLOGY].

Thyroid Accumulation

Failure to block thyroid uptake of iodine 123 may result in an increased long term risk for thyroid neoplasia. Administer thyroid blocking medications before AdreView administration [see DOSAGE AND ADMINISTRATION].

Risks with Concomitant Medication Withdrawal

Drugs which interfere with norepinephrine uptake or retention may decrease the uptake of AdreView (iobenguane i 123 injection for intravenous use) in neuroendocrine tumors and lead to false negative imaging results. When medically feasible, stop these drugs before AdreView (iobenguane i 123 injection for intravenous use) administration and monitor patients for the occurrence of clinically significant withdrawal symptoms, especially patients with elevated levels of circulating catecholamines and their metabolites [see DRUG INTERACTIONS].

Hypertension

Assess the patient's pulse and blood pressure before and intermittently for 30 minutes after AdreView (iobenguane i 123 injection for intravenous use) administration. AdreView (iobenguane i 123 injection for intravenous use) may increase release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in the clinical study. Prior to AdreView (iobenguane i 123 injection for intravenous use) administration, ensure emergency cardiac and anti-hypertensive treatments are readily available.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Iobenguane sulfate was not mutagenic in vitro in the Ames bacterial mutation assay and in the in vitro mouse lymphoma test, and was negative in the in vivo micronucleus test in rats.

Long-term animal studies have not been conducted to evaluate AdreView (iobenguane i 123 injection for intravenous use) 's carcinogenic potential or potential effects on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Any radiopharmaceutical, including AdreView (iobenguane i 123 injection for intravenous use) , has a potential to cause fetal harm. It is not known whether AdreView (iobenguane i 123 injection for intravenous use) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with AdreView (iobenguane i 123 injection for intravenous use) . AdreView (iobenguane i 123 injection for intravenous use) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether AdreView (iobenguane i 123 injection for intravenous use) is excreted into human milk. However, iodine 123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of AdreView (iobenguane i 123 injection for intravenous use) or not to administer AdreView (iobenguane i 123 injection for intravenous use) , taking into account the importance of the drug to the mother. Based on the physical half-life of iodine 123 (13.2 hours) nursing women may consider interrupting nursing for 6 days after AdreView (iobenguane i 123 injection for intravenous use) administration in order to minimize risks to nursing infants.

Pediatric Use

The safety and effectiveness of AdreView (iobenguane i 123 injection for intravenous use) have been established in the age groups 1 month to 16 years [see Clinical Studies]. Safety and effectiveness in pediatric patients below the age of 1 month have not been established [see WARNINGS AND PRECAUTIONS].

Geriatric Use

The AdreView (iobenguane i 123 injection for intravenous use) clinical study did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly population should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

AdreView (iobenguane i 123 injection for intravenous use) is excreted by the kidneys, and the risks of adverse reactions, increased radiation dose, and occurrence of falsely negative imaging results, may be greater in patients with severely impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. Consider assessment of renal function in elderly patients prior to AdreView (iobenguane i 123 injection for intravenous use) administration..

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The major manifestations of overdose relate predominantly to increased radiation exposure, with the long term risks for neoplasia.

CONTRAINDICATIONS

AdreView (iobenguane i 123 injection for intravenous use) is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Iobenguane is similar in structure to the antihypertensive drug guanethedine and to the neurotransmitter norepinephrine (NE). Iobenguane is, therefore, largely subject to the same uptake and accumulation pathways as NE. Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles. Iobenguane accumulates in adrenergically innervated tissues such as the adrenal medulla, salivary glands, heart, liver, spleen and lungs as well as tumors derived from the neural crest. By labeling iobenguane with the isotope iodine 123, it is possible to obtain scintigraphic images of the organs and tissues in which the radiopharmaceutical accumulates.

Pharmacodynamics

AdreView (iobenguane i 123 injection for intravenous use) is a diagnostic radiopharmaceutical which contains a small quantity of iobenguane that is not expected to produce a pharmacodynamic effect [see DESCRIPTION]. To minimize radiation dose to the thyroid gland, this organ should be blocked before dosing [see DOSAGE AND ADMINISTRATION]. Since iobenguane is excreted mainly via the kidneys, patients with severe renal insufficiency may experience increased radiation exposure and impaired imaging results. Frequent voiding should be encouraged after administration to minimize the radiation dose to the bladder [see WARNINGS AND PRECAUTIONS]. The calculation of the estimated radiation dose is shown in Table 2 [see DOSAGE AND ADMINISTRATION].

Pharmacokinetics

Iobenguane is rapidly cleared from the blood and accumulates in adrenergically innervated tissues [see CLINICAL PHARMACOLOGY]. Retention is especially prolonged in highly adrenergically innervated tissues (e.g., the adrenal medulla, heart, and salivary glands).

The majority of the iobenguane dose is excreted unaltered by the kidneys via glomerular filtration. A rapid initial clearance of circulating iobenguane is observed, followed by a slow clearance as iobenguane is released from other compartments. In patients with normal renal function, 70 to 90% of the administered dose is recovered unaltered in urine within 4 days. Iobenguane is not cleared by dialysis [see WARNINGS AND PRECAUTIONS]. Most of the remaining radioactivity recovered in the urine is in the form of the radioiodinated metabolite m-iodohippuric acid (MIHA) (typically ≤ 10%) and free radioiodide (typically ≤ 6%). The enzymatic process responsible for metabolism has not been well characterized and the pharmacologic activity of these metabolites has not been studied. Only a small amount ( < 1%) of the injected dose is eliminated via the feces.

Animal Toxicology and/or Pharmacology

Iobenguane sulfate testing in dogs revealed electrocardiographic (ECG) changes after administration of 202 times the mg/m2 conversion of the maximum human dose for a 60 kg adult; the no observable effect level (NOEL) was not determined. When iobenguane was tested in a cell system stably expressing hERG-1 potassium channels, inhibition of potassium channels was not observed at an 80 µM iobenguane concentration and the IC50 was 487 µM.

Clinical Studies

Pheochromocytomas and Neuroblastomas

The safety and efficacy of AdreView (iobenguane i 123 injection for intravenous use) were assessed in an open-label, multicenter, multinational trial of 251 subjects with known or suspected neuroblastoma or pheochromocytoma. Diagnostic efficacy for the detection of metabolically active neuroblastoma or pheochromocytoma was determined by comparison of focal increased radionuclide uptake on planar scintigraphy at 24 ± 6 hours post-administration of AdreView (iobenguane i 123 injection for intravenous use) against the definitive diagnosis (standard of truth). Anterior and posterior planar whole-body images, or alternatively whole-body overlapping spot images, were acquired from the head to below the knees. Additional spot images were performed as deemed appropriate at the discretion of the clinical image reviewer. SPECT imaging of the thorax and abdomen was then obtained when possible.

Of the 251 subjects dosed with AdreView (iobenguane i 123 injection for intravenous use) , 100 had known or suspected neuroblastoma and 151 had known or suspected pheochromocytoma. The population included 154 adults and 97 pediatric patients; the majority of adults were female (59%), the majority of pediatric subjects were male (58%). The adult subjects had a mean age of 49 years (range 17 to 88 years). The pediatric patients (56 males and 41 females) consisted of 32 infants (1 month up to 2 years of age), 62 children (2 years up to 12 years) and three adolescents (12 years up to 16 years).

The definitive diagnosis (standard of truth) for the presence or absence of metabolically active pheochromocytoma or neuroblastoma was determined by histopathology or, when histopathology was unavailable, a composite of imaging (i.e., CT, MRI, [131I]-mIBG scintigraphy), plasma/urine catecholamine and/or catecholamine metabolite measurements, and clinical follow-up. A standard of truth was available for 211 subjects (127 with pheochromocytoma, 84 with neuroblastoma) and this group comprised the diagnostic efficacy population. For 93 of these subjects, the standard of truth was based solely upon histopathology. Of 211 subjects in the efficacy population, all had planar scintigraphy and 167 subjects had SPECT in addition to planar imaging. All images were assessed independently by three readers blinded to all clinical data. Table 5 summarizes the AdreView (iobenguane i 123 injection for intravenous use) performance characteristics, by reader.

Table 5. AdreView (iobenguane i 123 injection for intravenous use) Planar Imaging: Sensitivity and Specificity

Outcome Reader A Reader B Reader C
Sensitivity (n = 159)
  Point estimate 0.80 0.77 0.79
  95% confidence interval 0.73 - 0.86 0.70 - 0.84 0.71 – 0.85
Specificity (n = 52)
  Point estimate 0.77 0.73 0.69
  95% confidence interval 0.63 - 0.87 0.59 - 0.84 0.55 – 0.81

Performance characteristics (sensitivity and specificity) of AdreView (iobenguane i 123 injection for intravenous use) planar imaging in patients with known or suspected neuroblastoma were similar to those in patients with known or suspected pheochromocytoma. Among the selected patients who also underwent SPECT imaging, similar performance characteristics of AdreView (iobenguane i 123 injection for intravenous use) scintigraphy were observed when SPECT plus planar imaging was compared to planar imaging alone.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Instruct patients to inform their physician or healthcare provider if they:

  1. are pregnant or breast feeding.
  2. are sensitive to iodine, an iodine-containing contrast agent or other products that contain iodine.
  3. are sensitive to Potassium Iodide Oral Solution, or Lugol's Solution.
  4. have reduced renal function.

Instruct patients to increase their level of hydration prior to receiving AdreView (iobenguane i 123 injection for intravenous use) and to void frequently for the first 48 hours following AdreView (iobenguane i 123 injection for intravenous use) administration.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Instruct patients to inform their physician or healthcare provider if they:

  1. are pregnant or breast feeding.
  2. are sensitive to iodine, an iodine-containing contrast agent or other products that contain iodine.
  3. are sensitive to Potassium Iodide Oral Solution, or Lugol's Solution.
  4. have reduced renal function.

Instruct patients to increase their level of hydration prior to receiving AdreView (iobenguane i 123 injection for intravenous use) and to void frequently for the first 48 hours following AdreView (iobenguane i 123 injection for intravenous use) administration.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

AdreView
(iobenguane I 123) Injection for Intravenous Use

DRUG DESCRIPTION

AdreView (iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

AdreView
  (iobenguane I 123) Structural Formula Illustration

Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3: Principal Radiation Emission Data – Iodine 123

Radiation Energy Level (keV) Abundance (%)
Gamma 159 83

External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4: Reduction in In-air Collision Kerma Caused by Lead Shielding*

Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4
*Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

AdreView
(iobenguane I 123) Injection for Intravenous Use

DRUG DESCRIPTION

AdreView (iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

AdreView
  (iobenguane I 123) Structural Formula Illustration

Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3: Principal Radiation Emission Data – Iodine 123

Radiation Energy Level (keV) Abundance (%)
Gamma 159 83

External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4: Reduction in In-air Collision Kerma Caused by Lead Shielding*

Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4
*Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

AdreView
(iobenguane I 123) Injection for Intravenous Use

DRUG DESCRIPTION

AdreView (iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

AdreView
  (iobenguane I 123) Structural Formula Illustration

Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3: Principal Radiation Emission Data – Iodine 123

Radiation Energy Level (keV) Abundance (%)
Gamma 159 83

External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4: Reduction in In-air Collision Kerma Caused by Lead Shielding*

Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4
*Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

AdreView Patient Information Including Side Effects

Brand Names: AdreView

Generic Name: iobenguane I-123 (Pronunciation: EYE oh BEN gwayne)

What is iobenguane I-123 (AdreView)?

Iobenguane I-123 is in a group of drugs called diagnostic radiopharmaceuticals (RAY dee oh far ma SOO tik als). Iobenguane I-123 is a radioactive agent that allows images of specific organs in the body to be detected by a gamma camera.

Iobenguane I-123 is used to detect certain kinds of cancer of the adrenal glands

Iobenguane I-123 may also be used for purposes not listed in this medication guide.

What are the possible side effects of iobenguane I-123 (AdreView)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • dizziness;
  • mild skin rash or itching;
  • bleeding around your IV needle; or
  • warmth, tingling, or cold feeling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the AdreView (iobenguane i 123 injection for intravenous use) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about iobenguane I-123 (AdreView)?

You should not receive this medication if you are allergic to iobenguane. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to potassium.

Before you are treated with iobenguane I-123, tell your doctor if you have kidney disease, a thyroid disorder, if you are dehydrated or unable to urinate, or if you are allergic to iodine.

Tell your doctor about all other medications you are using, especially antidepressants, cold medicines, blood pressure medications, or ADHD medications. You may need to stop using certain drugs for a short time before you receive iobenguane I-123

Drink extra fluids before you receive iobenguane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Iobenguane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Do not allow yourself to become dehydrated during the first few days after receiving iobenguane I-123. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

Side Effects Centers

AdreView Patient Information including How Should I Take

What should I discuss with my health care provider before receiving iobenguane I-123 (AdreView)?

You should not receive this medication if you are allergic to iobenguane. Tell your doctor if you have ever had any type of reaction to another contrast agent, or to potassium.

To make sure you can safely receive iobenguane I-123, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • a thyroid disorder;
  • if you are dehydrated or unable to urinate; or
  • if you are allergic to iodine.

FDA pregnancy category C. It is not known whether iobenguane I-123 will harm an unborn baby. Tell your doctor if you are pregnant before you are treated with iobenguane I-123.

It is not known whether iobenguane I-123 passes into breast milk or if it could harm a nursing baby. Do not breast-feed within 6 days after receiving iobenguane I-123. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Older adults may need kidney function tests before receiving iobenguane I-123. Your kidney function may also need to be watched closely after you have received this medication.

How is iobenguane I-123 given (AdreView)?

Iobenguane I-123 is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. It is usually given about 24 hours before your radiologic test.

At least 1 hour before you are treated with iobenguane I-123, you will be given a liquid drink that contains medicine to protect your thyroid from harmful radioactive effects of iobenguane I-123.

Drink extra fluids before you receive iobenguane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Iobenguane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Expect to urinate often during the first 48 hours after your test. You will know you are getting enough extra fluid if you are urinating more than usual during this time. Urinating often will help rid your body of the radioactive iodine.

Side Effects Centers

AdreView Patient Information including If I Miss a Dose

What happens if I miss a dose (AdreView)?

Since iobenguane I-123 is used only given once before your radiologic test, you will not be on a daily dosing schedule. Call your doctor if for some reason you will not be able to complete your radiologic test within 24 hours after you receive your injection.

What happens if I overdose (AdreView)?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving iobenguane I-123 (AdreView)?

Do not allow yourself to become dehydrated during the first few days after receiving iobenguane I-123. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

What other drugs will affect iobenguane I-123 (AdreView)?

You may need to stop using certain drugs for a short time before you receive iobenguane I-123. Tell your doctor about all other medications you are using, especially:

  • atomoxetine (Strattera);
  • labetalol (Normodyne, Trandate);
  • maprotiline (Ludiomil);
  • reserpine;
  • decongestant cold medicines, diet pills, and other stimulants;
  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), amoxapine (Asendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), desipramine (Norpramin), doxepin (Sinequan), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), and others; or
  • street drugs, especially cocaine.

There may be other drugs that can affect iobenguane I-123. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about iobenguane I-123.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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