Dotarem(Gadoterate meglumine)注射液-MRI造影剂
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
The risk for NSF appears highest among patients with:
Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
Acute kidney injury.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).
For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.1)].
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 - 59 mL/min/1.73m2) and little, if any, for patients with chronic, mild kidney disease (GFR 60 -89 mL/min/1.73m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
Report any diagnosis of NSF following DOTAREM administration to Guerbet LLC (1-877-729-6679) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).
Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. 
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown.
Hypersensitivity Reactions
Anaphylactic and anaphylactoid reactions have been reported with DOTAREM, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of DOTAREM administration and resolved with prompt emergency treatment.
Before DOTAREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to DOTAREM. 
Administer DOTAREM only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation. 
During and following DOTAREM administration, observe patients for signs and symptoms of hypersensitivity reactions.
Acute Kidney Injury
In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.
Extravasation and Injection Site Reactions
Ensure catheter and venous patency before the injection of DOTAREM. Extravasation into tissues during DOTAREM administration may result in tissue irritation.
ADVERSE REACTIONS
The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.
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商品名：Dotarem 
通用名：Gadoterate meglumine 
中文名：钆特酸葡甲胺
审批分类：标准审评
活性成分：
钆特酸葡甲胺，结构式如下：

作用机理：
钆特酸葡甲胺是一种顺磁分子，至于磁场中产生磁矩，增加邻近水质子的弛豫率，从而增加信号强度。
适应症：
2岁以上成人或儿童脑部、脊髓及相关组织的磁共振成像
剂型规格：
本品为无菌、澄清、无色至黄色水溶液，浓度为0.5 mmol/mL (376.9 mg/mL)。剂量按体重调整，推荐0.2 mL/kg即0.1 mmol/kg。
不良反应：
过敏、注射部位不适。
黑框警告：
肾源性系统性纤维化（Nephrogenic Systemic Fibrosis），严重肾病或急性肾损伤患者风险尤高。
药企：
Guerbet LLC.
补充说明：
钆特酸葡胺（gadoterate meglumine）是FDA批准的第7个含钆造影剂，用于中枢神经系统的核磁共振成像（MRI），前6个同类药物分别是Magnevist、Prohance、Omniscan、Optimark、Multihance、Gadavist。

PACKAGING
10 mL vials in a shrink wrapped package of 10 (NDC 67684-2000-1)
15 mL vials in a shrink wrapped package of 10 (NDC 67684-2000-2)
20 mL vials in a shrink wrapped package of 10 (NDC 67684-2000-3)
100 mL vials in a shrink wrapped package of 6 (NDC 67684-2000-4)
10 mL pre-filled syringe in a shrink wrapped package of 5 (NDC 67684-2000-5)
15 mL pre-filled syringe in a shrink wrapped package of 5 (NDC 67684-2000-6)
20 mL pre-filled syringe in a shrink wrapped package of 5 (NDC 67684-2000-7)

详细资料请阅读[附件]:http://medlibrary.org/lib/rx/meds/dotarem-1/