Ethiodized Oil

FDA Drug Information • Also known as: Lipiodol

Brand Names: Lipiodol
Dosage Form: OIL
Product Type: BULK INGREDIENT

⚠ Boxed Warning (Black Box)

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 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning 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 ).

Description

11 DESCRIPTION Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown. Lipiodol is a sterile, clear, pale yellow to amber colored oil. Lipiodol has a viscosity of 34 – 70 mPa·s at 20°C, and a density of 1.28 g/cm 3 at 20°C.

What Is Ethiodized Oil Used For?

1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Use a disposable syringe to draw and inject Lipiodol. 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. Lymphography Inject Lipiodol into a lymphatic vessel with radiologic monitoring. 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. Selective Hepatic Intra-arterial Use Inject 1.5 to 15 mL of Lipiodol slowly under continuous radiologic monitoring. Do not exceed 20 mL total dosage. 2.1 Dosing Guidelines Draw Lipiodol into a disposable syringe. Use the smallest possible amount of Lipiodol according to the anatomical area to be visualized. Hysterosalpingography Using aseptic technique inject Lipiodol into the endometrial cavity with fluoroscopic control. Inject increments of 2 mL of Lipiodol until tubal patency is determined; stop the injection if patient develops excessive discomfort. The total volume to be injected depends on the volume of the uterine cavity, usually not exceeding 15 mL. A 24-hour image can be obtained if, after slow peritoneal spillage, the evaluation of adhesions is needed. Perform the procedure during the follicular phase of the menstrual cycle. Before using Lipiodol exclude the presence of these conditions: pregnancy, uterine bleeding and endocervicitis, acute pelvic inflammatory disease, the immediate pre-or postmenstrual phase or within 30 days of curettage or conization. [see Contraindications ( 4 ) & Pregnancy ( 8.1 ) ]. 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. The following method is recommended for lymphography of the upper or lower extremities. Start the injection of Lipiodol into a lymphatic channel at a rate not to exceed 0.2 mL per minute. Inject the total dose of Lipiodol in no less than 1.25 hours. Use frequent radiologic monitoring to determine the appropriate injection rate and to follow the progress of Lipiodol within the lymphatics. Interrupt the injection if the patient experiences pain. Terminate the injection if lymphatic blockage is present to minimize introduction of Lipiodol into the venous circulation via lymphovenous channels. Terminate the injection as soon as Lipiodol is radiographically evident in...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS Adverse reactions caused by Lipiodol include hypersensitivity reactions, pulmonary embolism, pulmonary dysfunction, exacerbation of liver disease, procedural complications, abdominal pain, fever, nausea, vomiting, and thyroid dysfunction. 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 6.2 Postmarketing Experience The following adverse reactions (Table 1) have been identified during post approval use of Lipiodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary and cerebral embolism [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 ) ] Exacerbation of chronic liver disease [see Warnings and Precautions ( 5.3 ) ] Thyroid dysfunction [see Warnings and Precautions ( 5.4 ) ]. Thyroid dysfunction in the mother and the infant of a subsequent pregnancy [See Use in Specific Populations ( 8.1 )] Table 1: Adverse Reactions in the Postmarketing Experience System Organ Class Adverse Reaction Eye disorders retinal vein thrombosis General disorders and administration site conditions fever, pain, granuloma Immune system disorders hypersensitivity, anaphylactic reaction, anaphylactoid reaction, cardiovascular reactions Nervous system disorders cerebral embolism Respiratory, thoracic and mediastinal disorders pulmonary embolism, dyspnea, cough, acute respiratory distress syndrome Urinary system disorders renal insufficiency Hysterosalpingography Abdominal pain, foreign body reactions, exacerbation of pelvic inflammatory disease, salpingitis or pelvic peritonitis have been reported after the examination in case of latent infection. Lymphography Lymphangitis, thrombophlebitis, edema or exacerbation of preexisting lymphedema, dyspnea and cough, iodism (headache, soreness of mouth and pharynx, coryza and skin rash), allergic dermatitis, lipogranuloma, delayed healing at the site of incision. Selective Hepatic Intra-arterial Injection Abdominal pain, nausea, and vomiting are the most common reactions; other reactions include hepatic vein thrombosis, hepatic ischemia, liver enzymes abnormalities, transitory decrease in liver function, liver decompensation and renal insufficiency. Procedural risks include vascular complications and infections.

Drug Interactions

7 DRUG INTERACTIONS Lipiodol may interfere with thyroid function testing and with radioactive iodine uptake by the thyroid tissue during diagnostic or therapeutic procedures. ( 7.1 ) 7.1 Interference with Iodine-Based Diagnostic Tests and Iodine-Based Radiotherapy Following Lipiodol administration, ethiodized oil remains in the body for several months. Ethiodized oil interferes with radioactive iodine uptake by the thyroid for several weeks to months may impair visualization of thyroid scintigraphy and reduce effectiveness of iodine 131 treatment.

Contraindications

4 CONTRAINDICATIONS Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. 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, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. [see Use in Specific Populations ( 8.1 ) . ] 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. Selective Hepatic Intra-arterial Use 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. Hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. Lipiodol Hysterosalpingography is contraindicated in: pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. 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 Selective Hepatic Intra-arterial Injection is contraindicated in: the presence of dilated bile ducts...

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications ( 4 ) ]. The use of Lipiodol 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 Lipiodol either before or during pregnancy (see Clinical Considerations). Rare pregnancy outcomes reported in the post marketing setting with Lipiodol use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects or miscarriage (see Data). Animal reproduction studies have not been conducted using the indicated routes of administration of Lipiodol, it was not embryotoxic or teratogenic in animal studies with oral administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Maternal adverse reactions The use of Lipiodol before or during pregnancy may interfere with the thyroid function of the 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 Lipiodol either before or during pregnancy or if clinically indicated [see Warnings and Precautions ( 5.4 ) ]. Fetal / Neonatal adverse reactions The use of Lipiodol before or during pregnancy causes iodide transfer across the placenta which may interfere with fetal thyroid function and may...

Overdosage

10 OVERDOSAGE Overdose may lead to respiratory, cardiac or cerebral complications, which can potentially be fatal. Microembolisms to multiple organs may occur more frequently after overdose. Promptly initiate symptomatic treatment and support of vital functions.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Lipiodol is supplied in a box of one 10 mL ampoule, NDC 67684-1901-1. Lipiodol is supplied in a box of one 10 mL vial, NDC 67684-1901-2. Each vial is closed with a rubber stopper and sealed with an aluminum cap. Store at controlled room temperature 15°-30°C (59°-86°F) [see USP, Controlled Room Temperature (CRT)]. Protect from light. Remove from carton only upon use.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.