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AdreView is a diagnostic radiopharmaceutical agent for gamma-scintigraphy. It is indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. AdreView is the only FDA-approved Iodine-123 meta iodobezylguanidine (I 123 mIBG) for the imaging of these neuroendocrine tumors.
批准日期：2008年9月19日；公司： GE Healthcare
一般描述：AdreView(Iobenguane I 123注射剂)是一种消毒，无热原为静脉注射放射性药物。每mL含0.08 mg 硫酸iobenguane，在校正天和标签上为74 MBq(2 mCi)I 123 (作为硫酸iobenguane I 123)，23 mg磷酸二氢钠二水化物，2.8 mg磷酸氢二钠二水化物和10.3 mg(1% v/v)苯甲醇和pH 5.0 – 6.5。硫酸Iobenguane I 123 也已知为I 123 metaiodobenzlyguanidine sulfate和有下列结构式：
适应证：AdreView是一种为γ-显像的诊断用放射性药物。适用于检测原发或转移嗜铬细胞瘤或神经母细胞瘤作为其它诊断检验的辅助。
剂量和用法：
AdreView发射辐射和必须用适当安全措施处置。
用AdreView前给予封闭甲状腺阻滞药物。
给予前立即通过适宜的放射性校正系统测定患者剂量。
对≥ 16岁或< 16岁和≥ 70 kg患者：给予10 mCi (370 MBq)。
对< 16岁和< 70 kg患者：根据体重参考成年放射活性量计算。
禁忌证：已知对 iobenguane或硫酸iobenguane超敏性者。
警告和注意事项：
AdreView给予后曾接着超敏性反应。AdreView给药前应可得到超敏反应措施。
AdreView含苯甲醇(10.3 mg/mL)在早产儿或生产时低体重婴儿可能引起严重反应。
严重肾功能障碍患者可能增加辐射暴露和减低AdreView影像的质量。
阻断甲状腺碘摄入失效可能导致碘123在甲状腺内积蓄。
在神经内分泌肿瘤中阻断去甲肾上腺素摄入或消耗的药物 去甲肾上腺素贮存可能减低AdreView摄取。当医学上可行时，在给予AdreView前停用这些药物和监查患者撤药征象和症状。
不良反应：AdreView给药后曾报道严重超敏性反应。< 1%患者发生最常见不良反应、眩晕、皮疹、瘙痒、面红和注射部位出血。
药物相互作用：
阿米替林(Amitriptyline)和衍生物, 米帕明(imipramine)和衍生物，其它抑制去甲肾上腺素转运抗抑郁药、耗尽去甲肾上腺素贮存或抑制再摄取抗高血压药物，拟交感胺类和可卡因: 给予AdreView前中断5个生物半衰期。
特殊人群中的使用：
妊娠：任何放射性药物, 包括AdreView，可能造成胎儿伤害。
哺乳母亲：A decision应作出决定是否AdreView给药后中断哺乳或不给予AdreView，考虑药物对母亲的重要性。
儿童：尚未在< 1个月龄患儿确定安全性和有效性。
AdreView™ (Iobenguane I 123 Injection)
AdreView adds clarity to your clinical decisions.
AdreView is formulated with a high radiochemical purity (not less than 95%) than required by United States Pharmacopeia (USP) standards (90%) at a state of art facility in Arlington Heights, Illinois.1 GE Healthcare pharmacies offer reliable delivery and direct shipment of AdreView throughout the year.
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.
Iobenguane is rapidly cleared from the blood and accumulates in adrenergically innervated tissues. Retention is especially prolonged in highly adrenergically innervated tissues (e.g., the adrenal medulla, heart, and salivary glands).
AdreView is contraindicated to known hypersensitivity to iobenguane or iobenguane sulfate. (4) Hypersensitivity reactions have been reported following AdreView administration. Prior to administration, question the patient for a history of prior reactions to iodine, an iodine-containingcontrast 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 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 (6.2)]. 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 (11)]. Observe infants for signs or symptoms of benzyl alcohol toxicity following AdreView administration. AdreView safety and effectiveness have not been established in neonates (pediatric patients below the age of 1 month).
AdreView 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 clearance may also reduce the target to background ratios and decrease thequality of scintigraphic images. These risks importantly may limit the role of AdreView in the diagnostic evaluation of patients with severe renal impairment. AdreView safety and efficacy have not been established in these patients [see Clinical Pharmacology (12.2)].
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 (2.2)].
Drugs which interfere with norepinephrine uptake or retention may decrease the uptake of AdreView in neuroendocrine tumors and lead to false negative imaging results. When medically feasible, stop these drugs before AdreView 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 (7)].
Assess the patient's pulse and blood pressure before and intermittently for 30 minutes after AdreView administration. AdreView may increase release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in theclinical study. Prior to AdreView administration, ensure emergency cardiac and anti-hypertensive treatments are readily available. Hypersensitivity reactions have uncommonly been reported during the postmarketing use of AdreView [see Warnings and Precautions (5.1)].
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.
Prior to AdreView administration, please read the full prescribing information. | 
