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Lipiodol (ethiodized oil): Drug information

Lipiodol (ethiodized oil): Drug information
(For additional information see "Lipiodol (ethiodized oil): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Thromboembolism:

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

Appropriate use:

For intralymphatic, intrauterine, and selective hepatic intraarterial use only.

Brand Names: US
  • Lipiodol
Brand Names: Canada
  • Lipiodol Ultra Fluid
Pharmacologic Category
  • Diagnostic Agent, Radiologic Examination of GI Tract
Dosing: Adult

Use the smallest possible dose based on anatomical area to be visualized; dose varies with procedure. Refer to prescribing information for detailed dosing and administration information.

Hysterosalpingography

Hysterosalpingography: Note: Total volume to be injected depends on volume of uterine cavity, usually not exceeding 15 mL. Inject in 2 mL increments into the endometrial cavity until tubal patency is observed; discontinue use if excessive discomfort develops. Re-image after 24 hours if evaluation of adhesions is needed.

Lymphography

Lymphography: Note: Inject into lymphatic vessel under radiological monitoring. Interrupt injection if patient experiences pain; discontinue injection if lymphatic blockage is present (to minimize entry into the venous circulation via lymphovenous channels) and/or as soon as ethiodized oil is radiographically evident in the thoracic duct (to minimize entry into the subclavian vein and pulmonary embolization). Obtain immediate postinjection images; re-image at 24 or 48 hours to evaluate nodal architecture.

Unilateral lymphography of upper extremities: 2 to 4 mL

Unilateral lymphography of lower extremities: 6 to 8 mL

Penile lymphography: 2 to 3 mL

Cervical lymphography: 1 to 2 mL

Selective hepatic intra-arterial injection

Selective hepatic intra-arterial injection: Note: Dose depends on tumor size, local blood flow in liver and tumor: Dosage range: 1.5 to 15 mL administered slowly under continuous radiologic monitoring; discontinue administration when stagnation or reflux is evident. Limit dose to the quantity required for adequate visualization; maximum total dose: 20 mL

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Lipiodol (ethiodized oil): Pediatric drug information")

Lymphography

Lymphography: Infants, Children, and Adolescents: Injection: 1 to 6 mL according to area to be visualized; maximum dose: 0.25 mL/kg/dose; use the smallest possible dose based on anatomical area to be visualized; dose varies with procedure. Refer to prescribing information for detailed dosing and administration information.

Note: Inject into lymphatic vessel under radiological monitoring. Interrupt injection if patient experiences pain; discontinue injection if lymphatic blockage is present (to minimize entry into the venous circulation via lymphovenous channels) and/or 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 to 48 hours to evaluate nodal architecture.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Postmarketing:

Cardiovascular: Cerebral artery embolism, edema, hepatic vein thrombosis, ischemia (hepatic), pulmonary embolism, thrombophlebitis

Dermatitis: Allergic dermatitis

Endocrine & metabolic: Abnormal transaminase

Gastrointestinal: Abdominal pain, decompensated liver disease, nausea, peritonitis (pelvic), vomiting

Genitourinary: Pelvic inflammatory disease (exacerbation), salpingitis

Hematologic & oncologic: Granuloma (including lipogranuloma), lymphangitis, lymphedema (exacerbation)

Hepatic: Abnormal liver function (transitory decrease), hepatic insufficiency (irreversible)

Hypersensitivity: Anaphylaxis, hypersensitivity reaction, nonimmune anaphylaxis

Nervous system: Pain

Ophthalmic: Retinal vein occlusion

Renal: Renal insufficiency

Respiratory: Acute respiratory distress syndrome, cough, dyspnea

Miscellaneous: Fever, foreign body reaction, iodism, wound healing impairment (delayed)

Contraindications

Hypersensitivity to ethiodized oil; hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding

Hysterosalpingography: Pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre- or postmenstrual phase, within 30 days of curettage or conization, or reproductive tract neoplasia (known or suspected)

Lymphography: 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 injection: Presence of dilated bile ducts unless external biliary drainage was performed before injection

Canadian labeling: Additional contraindications (not in US labeling): Bronchography; IV, intrathecal, or intra-arterial (except for select use) use; acute parotiditis

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Serious and life-threatening anaphylactoid and anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations may occur. Avoid use in patients with a history of sensitivity to other iodine-based contrast media, bronchial asthma, or allergic disorders due to increased risk of hypersensitivity to ethiodized oil. Equipment for resuscitation and trained personnel experienced in handling emergencies should be immediately available. Most reactions occur within 30 minutes; delayed reactions may occur up to several days after administration. Monitor for ≥30 minutes following administration.

• Thromboembolism: [US Boxed Warning]: Pulmonary and cerebral embolism may result from inadvertent intravascular injection or intravasation of ethiodized oil; may occur immediately or a few hours to days after administration. Avoid use in patients with severely impaired lung function, cardiorespiratory failure, or right-sided cardiac overload. Radiological monitoring should be performed during injection; do not exceed the maximum recommended dose and rate of injection. To decrease the risk of pulmonary embolism during lymphography, obtain radiographic confirmation of intralymphatic injection and discontinue the procedure when ethiodized oil becomes visible in the thoracic duct or lymphatic obstruction is observed.

Disease-related concerns:

• Liver disease: Use with caution in patients receiving hepatic intra-arterial administration; procedural risks include vascular complications and infections. Hepatic intra-arterial use may exacerbate: portal hypertension and cause variceal bleeds; 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 death have also been reported.

• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).

• Thyroid disease: Hyperthyroidism or hypothyroidism may occur following administration of iodinated contrast media. Depending on dose and route of administration, ethiodized oil may remain in the body for several months. Use the lowest dose possible and consider monitoring thyroid function closely for several months after administration.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: For intralymphatic, intrauterine, and selective hepatic intra-arterial use only. Administer slowly with radiologic monitoring; do not exceed recommended dose.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Oil, Injection:

Lipiodol: (10 mL)

Generic Equivalent Available: US

No

Pricing: US

Oil (Lipiodol Injection)

480 mg/mL (per mL): $146.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Oil, Injection:

Lipiodol Ultra Fluid: 480 mg/mL (5 mL, 10 mL)

Administration: Adult

Ethiodized oil is a clear, pale yellow to amber colored oil; do not use if the color has darkened. Draw solution into a disposable syringe and use promptly; discard any unused portion of Lipiodol. For intralymphatic, intrauterine, and selective hepatic intra-arterial use only. Route of administration varies by indication.

Hysterosalpingography: Perform procedure during follicular phase of menstrual cycle. Inject into endometrial cavity with fluoroscopic control.

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

Upper or lower extremities administration: Start injection into lymphatic channel at a rate not to exceed 0.2 mL/min; inject total dose in no less than 1.25 hours.

Selective hepatic intra-arterial injection: Inject amount slowly under continuous radiologic monitoring.

Administration: Pediatric

Ethiodized oil is a clear, pale yellow to amber colored oil; do not use if the color has darkened. Draw solution into a disposable syringe and use promptly; discard any unused portion of Lipiodol. For intralymphatic, intrauterine, and selective hepatic intra-arterial use only. Route of administration varies by indication.

Lymphography: Inject into a lymphatic vessel under radiologic guidance to prevent inadvertent venous administration or intravasation. Upper or lower extremities administration: Start injection into lymphatic channel at a rate not to exceed 0.2 mL/min; inject total dose in no less than 1.25 hours.

Use: Labeled Indications

Hysterosalpingography: Radiopaque contrast agent for hysterosalpingography in adults

Lymphography: Radiopaque contrast agent for lymphography in adult and pediatric patients

Selective hepatic intra-arterial injection: Radiopaque contrast agent for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy

Loop Diuretics: May enhance the nephrotoxic effect of Iodinated Contrast Agents. Risk C: Monitor therapy

Sodium Iodide I131: Iodinated Contrast Agents may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue iodinated contrast agents before sodium iodide I-131 administration, and avoid concurrent use. Stop water soluble agents 2 months before, and stop lipophilic agents 6 months before, sodium iodide I-131 administration. Risk X: Avoid combination

Reproductive Considerations

Hysterosalpingography may be done to evaluate infertility, or prior to treatment with assisted reproductive technologies, among other indications (ACR 2017). Pregnancy must be excluded within 24 hours prior to administration, and the menstrual phase should be verified prior to the procedure. Lipiodol hysterosalpingography is contraindicated in the immediate pre- or postmenstrual phase.

Pregnancy Considerations

Ethiodized oil use during pregnancy causes iodine transfer and may interfere with thyroid function of the fetus; brain damage and permanent hypothyroidism may occur. Lipiodol hysterosalpingography is contraindicated during pregnancy. When pregnancy occurs following a hysterosalpingography using lipiodol, the infant should be monitored for thyroid dysfunction (Satoh 2015).

Breastfeeding Considerations

Ethiodized oil is present in breast milk.

Maternal use of ethiodized oil may increase iodide concentrations in breast milk and interfere with thyroid function of a breastfed infant. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Consider thyroid function testing in the infant.

Monitoring Parameters

Renal function prior to administration and after administration in patients with a history of renal impairment; thyroid function for several months after administration; monitor for hypersensitivity reactions for at least 30 minutes following administration.

Hysterosalpingography: Prior to use, exclude the presence of pregnancy, uterine bleeding, endocervicitis, and acute pelvic inflammatory disease and evaluate menstrual phase and history of curettage or conization.

Mechanism of Action

Ethiodized oil is used as a radiopaque contrast agent composed of iodine combined with ethyl esters of fatty acids of poppy seed oil, primarily as ethyl monoiodostearate and ethyl diiodostearate.

Pharmacokinetics (Adult Data Unless Noted)

Duration: Hepatic: ~2 to 4 weeks after intra-arterial administration; retention in liver tumor is prolonged in hepatocellular carcinoma.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CH) Switzerland: Lipiodol Ultra-fluide;
  • (CN) China: Ethiodized Poppyseed Oil;
  • (FR) France: Lipiodol;
  • (GR) Greece: Lipiodol;
  • (TH) Thailand: Lipiodol Uf
  1. American College of Radiology (ACR). ACR Practice Parameter for the Performance of Hysterosalpingography (Resolution 8). https://www.acr.org/-/media/ACR/Files/Practice-Parameters/HSG.pdf. Published 2001. Updated 2017. Accessed April 20, 2020.
  2. Lipiodol (ethiodized oil) [prescribing information]. Princeton, NJ: Guerbet LLC; April 2023.
  3. Lipiodol (ethiodized oil) [prescribing information]. Princeton, NJ: Guerbet LLC; November 2022.
  4. Lipiodol (ethiodized oil) [product monograph]. Paris, France: Guerbet; July 2017.
  5. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
  6. Rajebi MR, Chaudry G, Padua HM, et al. Intranodal lymphangiography: feasibility and preliminary experience in children. J Vasc Interv Radiol. 2011;22(9):1300-1305. [PubMed 21715187]
  7. Satoh M, Aso K, Katagiri Y. Thyroid dysfunction in neonates born to mothers who have undergone hysterosalpingography involving an oil-soluble iodinated contrast medium. Horm Res Paediatr. 2015;84(6):370-375. doi:10.1159/000439381 [PubMed 26402613]
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