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LIPIODOL® (ethiodized oil) Injection

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).

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INDICATIONS

Lipiodol is an oil-based radio-opaque contrast agent indicated for:

  • selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
  • hysterosalpingography in adults
  • lymphography in adult and pediatric patients

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).

Contraindications:

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.

To report SUSPECTED ADVERSE REACTIONS, contact GUERBET LLC at 1-855-266-5037 or PVReporting@Guerbet-group.com or  FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PHYSICAL CHARACTERISTICS

Viscosity
mPa*s at 20°C

Density
g/cm3 at 20°C

Lipiodol®

34 - 70

1.28

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

PACKAGING

Lipiodol (ethiodized oil) Injection, 480 mgI/mL

10mL ampoule in 1 carton (NDC 67684-1901-1)

PRESCRIBING INFORMATION

Each milliliter of Lipiodol contains 480 mg/mL of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil, and is available 10mL ampoules. Please see Prescribing Information.

LIPIODOL Injection Prescribing Information

For additional product related questions, please contact a Medical Liaison.

DOSAGE AND ADMINISTRATION

Use a glass syringe to draw and inject Lipiodol. 

Use the smallest possible amount of Lipiodol according to the anatomical area to be visualized.

Selective Hepatic Intra-arterial Use

Determine the dose depending on the tumor size, local blood flow in the liver and in the tumor(s).

Inject from 1.5 to 15 mL slowly under continuous radiologic monitoring. Stop the injection when stagnation or reflux is evident. Limit the dose to only the quantity required for adequate visualization. The total dose of Lipiodol administered should not exceed 20 mL.

Lymphography

Inject Lipiodol into a lymphatic vessel under radiologic guidance to prevent inadvertent venous administration or intravasation.

Adults:

  • unilateral lymphography of the upper extremities: 2 to 4 mL
  • unilateral lymphography of the lower extremities: 6 to 8 mL
  • penile lymphography: 2 to 3 mL
  • cervical lymphography: 1 to 2 mL

Pediatric patients:

  • Inject a minimum of 1 mL to a maximum of 6 mL according to the anatomical area to be visualized. 
  • Do not exceed 0.25 mL/kg.

Hysterosalpingography

Inject increments of 2 mL of Lipiodol into the endometrial cavity until tubal patency is determined; stop the injection if the patient develops excessive discomfort. Inject with radiologic monitoring. Re-image after 24 hours to establish whether Lipiodol has entered the peritoneal cavity.

CONTRAINDICATIONS

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

Selective Hepatic Intra-arterial Use in Patients with HCC

Lipiodol use is contraindicated in areas of the liver where the bile ducts are dilated unless external biliary drainage was performed before injection. 

Lymphography

Lipiodol Lymphography is contraindicated in patients with a 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, radiation therapy to the examined area.

Hysterosalpingography

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.

[see Warnings and Precautions]

WARNINGS

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).

Pulmonary and Cerebral Embolism

Pulmonary embolism may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation of Lipiodol and cause decreased pulmonary diffusing capacity and pulmonary blood flow, pulmonary infarction, acute respiratory distress syndrome and fatalities. Embolization of Lipiodol to brain and other major organs may occur. Avoid use of Lipiodol in patients with severely impaired lung function, cardiorespiratory failure, or right–sided cardiac overload. Perform radiological monitoring during the Lipiodol injection. Do not exceed the recommended maximum dose and rate of injection of Lipiodol. During lymphography to minimize the risk of pulmonary embolism obtain radiographic confirmation of intralymphatic (rather than venous) injection, and terminate the procedure when Lipiodol becomes visible in the thoracic duct or lymphatic obstruction is observed.

Hypersensitivity Reactions

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. Administer Lipiodol only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation; ensure continuous medical monitoring and maintain an intravenous access line. Most hypersensitivity reactions to Lipiodol occur within half an hour after administration. Delayed reactions can occur up to several days after administration. Observe patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following Lipiodol administration.

Exacerbation of Chronic Liver Disease

Lipiodol hepatic intra-arterial administration can exacerbate the following conditions: portal hypertension and cause variceal bleeds due to obstruction of the intrahepatic portal channels by opening a pre sinusoidal anastomosis; hepatic ischemia and cause liver enzyme elevations, fever and abdominal pain; hepatic failure and cause ascites and encephalopathy. Hepatic vein thrombosis, irreversible liver insufficiency and fatalities have been reported. Procedural risks include vascular complications and infections.

Thyroid Dysfunction

Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism or hypothyroidism in predisposed patients. Patients at risk are those with latent hyperthyroidism and those with Hashimoto thyroiditis, or history of thyroid irradiation. As Lipiodol may remain in the body for several months, thyroid diagnostic results can be affected for up to two years after lymphography.

To report SUSPECTED ADVERSE REACTIONS, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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

ORDERING INFORMATION

For U.S. customers only. To order products please contact Customer Service. Please contact Guerbet's Corporate office or an appropriate subsidiary if you are located outside the U.S.

LIPIODOL® is a Registered Trademark of Guerbet LLC, and is available by prescription only.

Legal Copyright 2014 Guerbet