Lipiodol<sup>® </sup>(Ethiodized Oil) Injection - Lymphography in Adult and Pediatric Patients

Lipiodol® (Ethiodized Oil) Injection - Lymphography in Adult and Pediatric Patients

Important Safety Information 

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.

Important Safety Information (Continued)

Indication and Usage

LIPIODOL® (ethiodized oil) injection is a prescription 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)

Contraindications

LIPIODOL® is contraindicated in patients with 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, or within 30 days of curettage or conization.
  • 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.
  • LIPIODOL® Selective Hepatic Intra-arterial Injection is contraindicated in the presence of dilated bile ducts unless external biliary drainage was performed before injection.

 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® 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 iodide content and can cause hyperthyroidism or hypothyroidism.

Adverse Reactions

  • 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, 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.

Use in Specific Populations

  • Pregnancy: 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. Untreated hypothyroidism in pregnancy is associated with adverse perinatal outcomes, such as spontaneous abortion, preeclampsia, preterm birth, abruptio placentae, and fetal death. The use of LIPIODOL® 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 also associated with increased fetal risk of low birth weight, fetal distress, and impaired neuropsychological development. Consider thyroid function testing during pregnancy if a woman was exposed to LIPIODOL® either before or during pregnancy, and also in infants whose mothers were exposed to LIPIODOL® before and during pregnancy or if clinically indicated.
  • Pregnancy Testing: Confirm that the patient has a negative pregnancy test within 24 hours before LIPIODOL® administration for hysterosalpingography.
  • Lactation: The use of LIPIODOL® 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 LIPIODOL® or if clinically indicated.
  • Pediatric: For lymphography use a dose of 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. Administer the smallest possible amount of LIPIODOL® according to the anatomical area to be visualized.
  • Geriatric: There are no studies conducted in geriatric patients.
  • Renal Impairment: Prior to an intra-arterial administration of LIPIODOL® screen all patients for renal dysfunction by obtaining history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.

For more information, see Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Lymphography in Adult and Pediatric Patients

I. The Lymphatic System and Lymphography

The Lymph (lymphatic) System:
A network of organs, lymph nodes, lymph ducts, and lymph vessels that make and move lymphatic fluid
from tissues to the bloodstream. The lymph system is a major part of the body’s immune system.2

Lymphangiography /Lymphography:
The visualization of lymphatics (lymphangiography) lymph nodes (lymphadenography), or both by
radiography following the intralymphatic injection of a contrast medium, usually an iodized oil.3

  • Using an iodized oil allows for additional imaging to be performed months, or sometime years,
    allowing one to evaluate the effects of treatment or progression of disease.4

Reasons for performing lymphography include4:

Chylous Syndromes Obstruction and Collateral Flow
  • Chylous Ascites
  • Chylothorax
  • Chyluria
  • External Genital lymphedema
  • Lymphatic leaks in the chest or abdomen
  • Lympholymphatic and Lymphovenous Anastomoses
  • Perineural and Perivascular Spaces
  • Lymphocele and Lymphatic Fistula

Use of Lipiodol® (Ethiodized Oil) Injection in Lymphography

II. Use of Lipiodol® (Ethiodized Oil) Injection in Lymphography

Indication
Lipiodol is an oil-based radiopaque contrast agent indicated for lymphography in adult and pediatric patients1

Dosage and Administration1
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
  • penil 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 lymphatic blockage is present to minimize introduction of Lipiodol into the venous circulation via lymphovenous channels. Tenninate the injection as soon as Lipiodol is radiographically evident in the thoracic duct to minimize entry of Lipiodol into the subclavian vein and pulmonary embolization. Obtain immediate post-injection images. Re-image at 24 or 48 hours to evaluate nodal architecture.

 
Bt Lymphography

Documentation

Lipiodol® (Ethiodized Oil) Injection - Lymphography in Adult and Pediatric Patients Brochure

Important Safety Information 

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.

 

Indication and Usage

LIPIODOL® (ethiodized oil) injection is a prescription 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)

Contraindications

LIPIODOL® is contraindicated in patients with 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, or within 30 days of curettage or conization.
  • 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.
  • LIPIODOL® Selective Hepatic Intra-arterial Injection is contraindicated in the presence of dilated bile ducts unless external biliary drainage was performed before injection.

 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® 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 iodide content and can cause hyperthyroidism or hypothyroidism.

Adverse Reactions

  • 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, 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.

Use in Specific Populations

  • Pregnancy: 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. Untreated hypothyroidism in pregnancy is associated with adverse perinatal outcomes, such as spontaneous abortion, preeclampsia, preterm birth, abruptio placentae, and fetal death. The use of LIPIODOL® 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 also associated with increased fetal risk of low birth weight, fetal distress, and impaired neuropsychological development. Consider thyroid function testing during pregnancy if a woman was exposed to LIPIODOL® either before or during pregnancy, and also in infants whose mothers were exposed to LIPIODOL® before and during pregnancy or if clinically indicated.
  • Pregnancy Testing: Confirm that the patient has a negative pregnancy test within 24 hours before LIPIODOL® administration for hysterosalpingography.
  • Lactation: The use of LIPIODOL® 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 LIPIODOL® or if clinically indicated.
  • Pediatric: For lymphography use a dose of 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. Administer the smallest possible amount of LIPIODOL® according to the anatomical area to be visualized.
  • Geriatric: There are no studies conducted in geriatric patients.
  • Renal Impairment: Prior to an intra-arterial administration of LIPIODOL® screen all patients for renal dysfunction by obtaining history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.

For more information, see Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Reimbursement Information*

For further assistance, please contact For further assistance, please contact LIPIODOL® Reimbursement Support at 1-855-368-2736, Monday–Friday, 7 am–7 pm ET

Lipiodol® (Ethiodized Oil) Injection is a registered trademark of Guerbet LLC or its affiliates and is available by prescription only. 

References

1. Lipiodol Full Prescribing Information. Revised May 2018
2. Lymph system. 2012. Access at: https://medicineplus.gov/ency/article/002247.htm
3. Medical Dictionary for the Health Professions and Nursing © Farlex 2012 
4. Guermazi et al. Lymphography: An Old Technique Retains Its Usefulness. Radiographics 2003; 23:1541-1560
5. Pieper et al. Back to the Future Lipiodol in Lymphography-From Diagnostics to Theranostics. Investigative Radiology 2019; DOI 10.1097RLI.000000000000578

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