Ethiodized Oil

Ethiodized Oil is a radio-opaque contrast agent fused used for hysterosalpingography in adults, lymphography in adult and pediatric patients, and selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). 

• Ethiodized Oil is available under the following different brand names: Lipiodol.

Common side effects of Ethiodized Oil include:

• Delayed healing at the injection site, and
• Diarrhea

Serious side effects of Ethiodized Oil include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Abdominal pain,
• Anxiety,
• Vision changes,
• Chest pain or pressure,
• Cough,
• Little or no urination,
• Depression,
• Difficulty swallowing,
• Lightheadedness,
• Dizziness,
• Fainting,
• Fast heartbeats,
• Fever,
• Headache,
• Loss of appetite,
• Lower back or side pain,
• Muscle cramps and stiffness,
• Nausea,
• Vomiting,
• Pain, tenderness, or swelling of the foot or leg,
• Skin rash,
• Itching,
• Redness of the skin,
• Shortness of breath,
• Sweating,
• Difficulty sleeping,
• Tiredness,
• Weakness,
• Weight gain or loss, and
• Yellowing of your eyes or skin (jaundice)

Rare side effects of Ethiodized Oil include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable oil

• 480 mg/mL (iodine)

Hysterosalpingography

Adult dosage

• Inject increments of 2 mL until tubal patency is determined; stop the injection if a patient develops excessive discomfort.
• Reimage after 24 hours to establish whether Ethiodized Oil has entered the peritoneal cavity.

Lymphography

Adult dosage

• Unilateral lymphography of the upper extremities: 2-4 mL
• Unilateral lymphography of the lower extremities: 6-8 mL
• Penile lymphography: 2-3 mL
• Cervical lymphography: 1-2 mL
• Upper or lower extremities administration
  • Start the injection into a lymphatic channel at a rate not to exceed 0.2 mL/min.
  • Inject the total dose in no less than 1.25 hours.
  • Use frequent radiologic monitoring to determine the appropriate injection rate and follow the lymphatics progress.
  • Interrupt the injection if the patient experiences pain.
  • Terminate the injection if a lymphatic blockage is present to minimize the introduction of Ethiodized Oil into the venous circulation via lymph venous channels.
  • Terminate the injection as soon as Ethiodized Oil is radiographically evident in the thoracic duct to minimize entry into the subclavian vein and pulmonary embolization.
• Obtain immediate post-injection images.
• Reimage at 24 or 48 hours to evaluate nodal architecture.

Pediatric dosage

• 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.
• Upper or lower extremities administration
  • Start the injection into a lymphatic channel at a rate not to exceed 0.2 mL/min.
  • Inject the total dose in no less than 1.25 hours.
  • Use frequent radiologic monitoring to determine the appropriate injection rate and follow the lymphatics progress.
  • Interrupt the injection if the patient experiences pain.
  • Terminate the injection if the lymphatic blockage is present to minimize the introduction of Ethiodized Oil into the venous circulation via lymph venous channels.
  • Terminate the injection as soon as Ethiodized Oil is radiographically evident in the thoracic duct to minimize entry into the subclavian vein and pulmonary embolization.
• Obtain immediate post-injection images.
  • Reimage at 24 or 48 hours to evaluate nodal architecture.

Hepatocellular Carcinoma

Adult dosage

• Inject from 1.5-15 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.
• Total dose administered should not exceed 20 mL.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ethiodized Oil has severe interactions with no other drugs.
• Ethiodized Oil has serious interactions with no other drugs.
• Ethiodized Oil has moderate interactions with the following drugs.
  • iodixanol
  • metformin
  • sodium iodide I-131
  • voclosporin
• Ethiodized Oil has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• NOT for IV, IM, IT, or SC use (see Black Box Warnings)
• Hypersensitivity
• Hyperthyroidism
• Traumatic injuries
• Recent hemorrhage or bleeding
• Hysterosalpingography
• Pregnancy
• Acute pelvic inflammatory disease
• Marked cervical erosion.
• Endocervicitis and intrauterine bleeding in the immediate premenstrual or postmenstrual phase
• Within 30 days of curettage or conization
• Known or suspected reproductive tract neoplasia
• Lymphography
• Right to left cardiac shunt.
• Advanced pulmonary disease
• Tissue trauma or hemorrhage
• Advanced neoplastic disease with expected lymphatic obstruction
• Previous surgery interrupted the lymphatic system.
• Radiation therapy in the examined area
• Hepatic intra-arterial use
• Areas of the liver where the bile ducts are dilated (unless external biliary drainage was performed before injection)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ethiodized Oil?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ethiodized Oil?”

Cautions

• Embolism
  • Embolization to the lungs, brain, and other major organs may occur.
  • Pulmonary embolization (PE) may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation; this may cause decreased pulmonary diffusing capacity and pulmonary blood flow, pulmonary infarction, acute respiratory distress syndrome, and fatalities.
  • Avoid use in patients with severely impaired lung function, cardiorespiratory failure, or right–sided cardiac overload.
  • Perform radiological monitoring during the injection.
  • Do not exceed the recommended maximum dose and rate of injection.
  • During lymphography, minimize the risk of PE by obtaining radiographic confirmation of intratympanic (rather than venous) injection, and terminate the procedure when Ethiodized Oil 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.
  • Avoid use with a history of sensitivity to other iodinated contrast agents, bronchial asthma, or allergic disorders.
  • Observe patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following administration.
• Exacerbation of chronic liver disease
  • Hepatic intra-arterial injection may exacerbate chronic liver disease conditions including:
  • Portal hypertension causes variceal bleeds due to obstruction of the intrahepatic portal channels by opening a presinusoidal anastomosis.
  • Hepatic ischemia cause liver enzyme elevations, fever, and abdominal pain
  • Hepatic failure cause ascites and encephalopathy
  • Hepatic vein thrombosis, irreversible liver insufficiency, and fatalities 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 a history of thyroid irradiation.
  • Ethiodized Oil may remain in the body for several months; depending on the dose administered and route of administration, therefore, thyroid diagnostic results can be affected for up to 2 years after lymphography; keep the dose as low as possible and consider monitoring thyroid function closely for several months after the administration of therapy.
  • Interferes with radioactive iodine uptake by thyroid tissue and may impair visualization of thyroid scintigraphy and reduce the effectiveness of iodine 131 treatment.
• Overdose
  • Overdose may lead to respiratory, cardiac, or cerebral complications, which can potentially be fatal.
  • Micro embolisms to multiple organs may occur more frequently after overdose.
  • Promptly initiate symptomatic treatment and support of vital functions

Pregnancy and Lactation

• Therapy is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure.
• Use before or during pregnancy may interfere with thyroid function in both the pregnant woman and her fetus and may affect fetal development; there are maternal, fetal, and neonatal clinical considerations for women who are exposed to drugs either before or during pregnancy.
• Rare pregnancy outcomes reported in the post-marketing setting in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects or miscarriage.
• Therapy administered before or during pregnancy may interfere with the thyroid function of a pregnant woman.
• Untreated hypothyroidism in pregnancy is associated with adverse perinatal outcomes, such as spontaneous abortion, preeclampsia, preterm birth, abruptio placentae, and fetal death; consider thyroid function testing during pregnancy if a woman was exposed to drug either before or during pregnancy or if clinically indicated.
• Therapy administration before or during pregnancy causes iodide transfer across the placenta which may interfere with fetal thyroid function and may affect fetal development.
• Untreated hypothyroidism is associated with increased fetal risk of low birth weight, fetal distress, and impaired neuropsychological development; consider thyroid function testing in infants whose mothers were exposed to the drug before and during pregnancy or if clinically indicated.
• Confirm that the patient has a negative pregnancy test within 24 hours before drug administration for hysterosalpingography.
• Lactation
  • Ethiodized Oil is present in human milk; there are no data on the effects of the drug on the breastfed infant, or effects on milk production, however, use may increase the concentration of iodide in human milk and may interfere with the thyroid function of the breastfed infant.
  • Consider thyroid function testing in a breastfed infant whose mother was exposed to a drug or if clinically indicated.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfeeding child from the drug or underlying maternal condition.