EOVIST® (gadoxetate disodium) Injection
INDICATIONS AND USAGE
EOVIST® (gadoxetate disodium) Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

批准日期：2008年7月3日；公司：Bayer HealthCare Pharmaceuticals Inc.

一般描述：EOVIST (gadoxetate disodium)是顺磁共振造影剂。EOVIST以消毒透明，无色至淡黄色水性溶液提供，为静脉注射。EOVIST含活性药学有效成分gadoxetate disodium (Gd-EOB-DTPA)，化学上被设计为 (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9-triazaundecanedioic acid, gadolinium complex, disodium salt。相对分子量725.72和经验式GdC23H28N3O11Na2。

水溶液结构式为：

适应证：EOVIST注射剂是一种钆的造影剂适用于肾源性系静脉肝脏的T1加权磁共振成像(MRI)中使用以检测和成年中有已知或怀疑的局部肝病病变特征。

剂量和用法：推荐EOVIST的剂量是0.1 mL/kg体重(0.025 mmol/kg体重)给予未稀释作为单次静脉推注注射流速接近2 mL/秒。注射后用生理盐水冲洗。

禁忌证：无。

不良反应：在临床中报道发生率0.1% – 1.0%的不良反应是头痛、眩晕、味觉障碍, 嗅觉倒错, 血压增加、面红, 呼吸疾患、呕吐、恶心、皮疹、瘙痒、注射部位反应和热感。

黑框警告：肾源性系统纤维化在有：急性或慢性严重 肾功能障碍患者中(肾小球过滤率 <30 mL/min/1.73m2),或由于肝肾综合征或在肝移植围手术期任何严重程度的急性肾功能障碍，钆的造影剂增加肾源性系统纤维化(NSF)风险。在这些患者中，避免使用钆的造影剂除非诊断信息是必不可少的和用无对比剂增强磁共振成像(MRI)不能得到。NSF可能导致死亡或使衰弱的系统性纤维化影响皮肤、肌肉和内脏器官。筛选所有患者肾功能失调通过获得病史和/或实验室检验，当给予某种钆的造影剂，不要超过推荐剂量而且任何再给药前要有充分时间从体内消除药物。

药物相互作用：
阴离子药物主要排泄至胆汁(例如利福平)可能减低肝对比剂的增强作用和胆汁排泄EOVIST。

特殊人群中使用：
妊娠：给予动物资料，可能引起胎儿危害。

Eovist
DRUG DESCRIPTION
EOVIST (gadoxetate disodium) is a paramagnetic contrast agent for MRI. EOVIST is provided as a sterile, clear, colorless to pale yellow aqueous solution for intravenous injection.

EOVIST contains the active pharmaceutical ingredient gadoxetate disodium (Gd-EOB-DTPA), which is designated chemically as (4S)-4-(4-Ethoxybenzyl)-3,6,9-tris(carboxylatomethyl)-3,6,9triazaundecanedioic acid, gadolinium complex, disodium salt with a molecular weight of 725.72 and an empirical formula of GdC23H28N3O11Na2. The structural formula of gadoxetate disodium in aqueous solution is:

Each mL of EOVIST contains 181.43 mg of gadoxetate disodium (equivalent to 0.25 mol/L gadoxetate disodium) and the excipients caloxetate trisodium, trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment), and water for injection. EOVIST contains no antimicrobial preservative.

EOVIST has a pH of 6.8 to 8. Pertinent physiochemical data are provided below:

TABLE 2 : Physicochemical Properties

Osmolality at 37°C (Osm/kg H2O) 0.688
Viscosity at 37°C (cP) 1.19
Density at 37°C (g/mL) 1.088

What are the possible side effects of gadoxetate (Eovist)?
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.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

Call your doctor at once if you have any of these serious side effects:

trouble breathing;
chest pain;
fast or pounding heartbeats; or
skin changes where the injection was given.
Less serious side effects...

Read All Potential Side Effects and See Pictures of Eovist

Eovist Patient Information Including Side Effects
Brand Names: Eovist
Generic Name: gadoxetate (Pronunciation: gad OX e tate)
What is gadoxetate (Eovist)?
What are the possible side effects of gadoxetate (Eovist)?
What is the most important information I should know about gadoxetate (Eovist)?
What should I discuss with my health care provider before receiving gadoxetate (Eovist)?
How is gadoxetate used (Eovist)?
What happens if I miss a dose (Eovist)?
What happens if I overdose (Eovist)?
What should I avoid after receiving gadoxetate (Eovist)?
What other drugs will affect gadoxetate (Eovist)?
Where can I get more information?

What is gadoxetate (Eovist)?
Gadoxetate is a contrast agent. Gadoxetate produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadoxetate is used to help diagnose certain disorders of the liver.

Gadoxetate may also be used for other not those listed in this medication guide.

What are the possible side effects of gadoxetate (Eovist)?
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.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

Call your doctor at once if you have any of these serious side effects:

trouble breathing;
chest pain;
fast or pounding heartbeats; or
skin changes where the injection was given.
Less serious side effects may include:

headache, tired feeling;
dizziness, spinning sensation;
nausea, vomiting;
back pain;
dry mouth, mouth pain or discomfort;
decreased sense of taste or smell;
increased sweating or salivation;
warmth, redness, or tingly feeling under your skin;
mild skin rash or itching;
feeling unusually hot; or
cold feeling, warmth, pain, or burning where the injection was given.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gadoxetate (Eovist)?
Gadoxetate can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:

burning, itching, swelling, and tightening or hardening of your skin;
muscle weakness;
pain or stiffness in your arms, hands, legs, or feet;
deep bone pain in your ribs or your hips;
yellow patches on the whites of your eyes; or
skin redness or discoloration.
Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadoxetate.

Also tell your doctor if you have liver disease, a bleeding or blood-clotting disorder, a history of stroke or blood clots, circulation problems, asthma or allergies, if you have had a liver transplant, or if you are on dialysis.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

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