Included as part of the PRECAUTIONS section.
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.
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.
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
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals have not been performed to
evaluate carcinogenic potential, or whether Lipiodol can affect fertility in
males or females. Lipiodol did not demonstrate mutagenic potential in bacterial
reverse mutation assays (in vitro), in a chromosomal aberration test in the
mouse lymphoma assay (in vitro), and was negative in an in vivo micronucleus
test in rats after intravenous injection of 479 mg I/kg.
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies of
Lipiodol effects in pregnant women. Use Lipiodol during pregnancy only if
It is not known whether Lipiodol can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity. The
use of Lipiodol during pregnancy causes iodine transfer which may interfere
with the thyroid function of the fetus and result in brain damage and permanent
hypothyroidism. Institute thyroid function testing and careful medical
monitoring of the neonate exposed to Lipiodol in utero.
Animal reproduction studies have not been conducted using
the indicated routes of administration of Lipiodol. Lipiodol was not
embryotoxic or teratogenic in rats after oral administration of up to 110 mg
Iodine/kg each day between gestation days 6 to 17, or in rabbits after 4-5
intermittent (once every three days) oral administrations of 12.5 mg Iodine/kg
between gestation days 6 to 18.
No nonclinical lactation studies of Lipiodol have been
Lipiodol is excreted in human milk. Avoid use of Lipiodol
in a nursing woman because of risk of hypothyroidism in nursing infants. If
breastfeeding is continued the neonate's thyroid function should be monitored.
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.
There are no studies conducted in geriatric patients.
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.