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.
IMPORTANT SAFETY INFORMATION
WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY
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 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.