Drug: AdreView

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: 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

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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 effectsLearn More »

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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].

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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. Read the AdreView Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.

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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.

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

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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.

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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.

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