Dotarem® (gadoterate meglumine) Injection, is the first macrocyclic and ionic gadolinium-based contrast agent in the USA.


                                               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 [see Warnings and Precautions].
  • 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].--------------------------------------------------------------

Contraindicated in patients with a history of clinically important hypersensitivity reactions to DOTAREM®.

The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered. Monitor patients closely for need of emergency cardiorespiratory support.

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.

Ensure catheter and venous patency before the injection of DOTAREM®. Extravasation into tissues during DOTAREM administration may result in tissue irritation.

The most common adverse reactions associated with DOTAREM® in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.

For more information about DOTAREM®, including full Boxed WARNING, please see the Full Prescribing Information.



Lipiodol® (ethiodized oil) Injection is approved in the US for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC), lymphography in adult and pediatric patients, and hysterosalpingography in adults and is the only oil-based contrast agent in the USA.


Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose (5.1).


Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. 

Lipiodol selective hepatic intra-arterial injection is contraindicated in the presence of dilated bile ducts unless external biliary drainage was performed before injection. 

Lipiodol lymphography is contraindicated in right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage, advanced neoplastic disease with expected lymphatic obstruction, previous surgery interrupting the lymphatic system, or radiation therapy to the examined area. 

Lipiodol hysterosalpingography is contraindicated in pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization. 

Warnings and Precautions: 

Pulmonary and cerebral embolism may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation of Lipiodol. Avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload. 

Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Lipiodol administration. Avoid use in patients with a history of sensitivity to other iodinated contrast agents, bronchial asthma or allergic disorders because of an increased risk of a hypersensitivity reaction to Lipiodol. 

Lipiodol hepatic intra-arterial administration can exacerbate chronic liver disease. 

Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism or hypothyroidism in predisposed patients. 

Adverse Reactions: 

Adverse reactions caused by Lipiodol include hypersensitivity reactions, pulmonary and cerebral embolism, pulmonary dysfunction, exacerbation of liver disease, procedural complications, abdominal pain, fever, nausea, vomiting, and thyroid dysfunction. 

For more information about Lipiodol, including Boxed WARNING, please see the Full Prescribing Information.

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