COMPANY CORE DATA SHEET (CCDS)

LIPIODOL ULTRA-FLUID

(Ethyl esters of iodized fatty acids of poppy seed oil)


International Birth Date: March 31st, 1978


GUERBET
BP 57400
95943 Roissy CdG Cedex France

Version 2 – 11th August 2015

1 NAME OF THE MEDICINAL PRODUCT

LIPIODOL ULTRA-FLUID, 480 mg I/mL, solution for injection

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ethyl esters of iodinated fatty acids of poppy seed oil: 10 mL
Corresponding to an iodine content of: 480 mg/mL

Viscosity at 15°C 70 cP (centipoises)
Viscosity at 37°C 25 cP
Relative density at 15°C 1.280

This product does not contain any excipient.

3 PHARMACEUTICAL FORM

Solution for injection.
Clear, pale yellow to amber-coloured oil.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Registered indications may vary by country.

This medicinal product is for diagnostic use only.

Lipiodol Ultra-Fluid is indicated for (some indications may not be approved depending on the country):

– Hysterosalpingography.
– Ascending urethrography.
– Lymphography.
– Sialography.
– Fistulography and exploration of abscesses.
– Exploration of frontal sinuses.
– Pre and post-operative cholangiography.
– Visualisation and localisation (by selective intra-arterial use during CT) of liver lesions in adults with known or suspected hepatocellular carcinoma.
– Visualisation, localisation and vectorisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma at intermediate stage in adults.
– Selective embolisation in combination with Histoacryl glue (particularly for arteriovenous malformations or aneurysms)
– Selective injections of Lipiodol Ultra-Fluid into the hepatic artery for diagnostic purposes where a spiral CT scan is not practical.
– Prevention of severe cases of iodine deficiency, in endocrinology. This treatment should only be used when other methods of supplementation, particularly iodization of salt and/or drinking water, cannot be undertaken.

4.2 Posology and method of administration

Posology

The volume to be administered depends on the particular requirements of the technique and the size of the patient.

IndicationRecommended usage
Lymphography3 to 10 mL (maximum 20 mL)
Hysterosalpingography10 to 20 mL, depending on the volume of the uterine cavity
SialographyUntil the gland fills, maximum 5 mL
Diagnosis of hepatic lesions2 to 10 mL
ChemoembolisationDepends on the dimensions of the lesions.Maximum 15 mL.
Embolisation with surgical glue Depends on the dimensions of the lesions.Mixture with the embolizing fluid 50/50 (can vary from 20 to 80%).The volume injected should not exceed 15 mL.
 Endocrinology
– Adult and children aged over 4 years
– Children aged under 4 years
– Patients with hypothyroidism (thyroid nodules)  
1 mL every 3 years
0.5 mL every 2 years (maximum 3 mL)
0.2 mL

 

Paediatric population
The dose should be proportionally decreased in children. In infants between 1 and 2 years of age, a dose of 1 mL per extremity is sufficient.

Underweighted patients
The dose should be proportionally decreased in this population.

Elderly
The drug must be administered cautiously in patients over 65 years presenting with underlying pathologies of the cardiovascular, respiratory or neurological system.
In elderly patients with cardiorespiratory failure, the dose should be adapted or the examination itself cancelled, since a portion of the product will temporarily embolize the pulmonary capillaries

Method of administration

Lipiodol Ultra Fluid should be administered via a suitable glass syringe and cannula by slow injection or cannulation.
Administration in lymphography is by lymphatic cannulation. It may be preceeded by the injection of a dye to locate the lymph collectors.
Administration in hysterosalpingography is by slow injection into the uterine cervical canal via a syringe and suitable cannula.
Administration in sialography is by cannulation of salivary duct.
Administration in endocrinology use is by intramuscular injection.
Administration in embolisation is intra-arterial.

Administration in chemoembolisation is intra-arterial.
The administration is by selective intra-arterial catheterism of the hepatic artery. The procedure should be performed within a typical interventional radiology setting with the appropriate equipment. The dose of Lipiodol Ultra-Fluid depends on the extent of the lesion, but should usually not exceed a total dose of 15 mL in adults.
Lipiodol Ultra-Fluid can be mixed with anticancer drugs such as cisplatin, doxorubicin, epirubicin and mitomycin. Instructions and precautions for use of the anticancer drugs must be strictly followed.

Instructions for preparation of the mixture of Lipiodol Ultra-Fluid with an anticancer drug:
– Prepare two syringes large enough to contain the total volume of mixture. The first syringe contains the anticancer drug solution, the second syringe contains Lipiodol Ultra-Fluid.
– Connect the two syringes to a 3-way stopcock.
– Perform 15 to 20 back and forth movements between the two syringes to obtain a homogeneous mixture. It is recommended to start by pushing the syringe with the anticancer drug first.
– The mixture is to be prepared at the time of use and must be used promptly after preparation (within 3 hours). If necessary during the interventional radiology procedure, the mixture can be re-homogenized as described above.
– When the adequate mixture is obtained, use a 1 to 3 mL syringe to inject in the micro-catheter.
The procedure can be repeated every 4 to 8 weeks according to tumour response and patient conditions.

Paediatric population
The efficacy and safety of the use of Lipiodol Ultra-Fluid for Trans-Arterial Chemo-Embolisation of hepatocellular carcinoma have not been established in children.
Elderly
The product must be administered with special care in patients over 65 years of age with underlying diseases of the cardiovascular, respiratory or nervous systems.

4.3 Contraindications

– Hypersensitivity to Lipiodol Ultra Fluid (esters of iodised fatty acids of poppy-seed oil)
– Manifest hyperthyroidism
– Patients with traumatic injuries, recent haemorrage or bleeding (risk of extravasation or embolism)
– Hysterosalpingography during pregnancy or acute pelvic inflammation
– Bronchography (it would rapidly fill the bronchioles and alveoli)

Chemoembolisation (interventional radiology)
The toxicity of intra-arterial chemotherapy using Lipiodol Ultra-fluid which loads the bile duct means the treatment is contraindicated in areas of the liver where the bile ducts are dilated, unless there is post drainage.

4.4 Special warnings and special precautions for use

Lipiodol Ultra-Fluid must not to be administered by intravenous, intraarterial (apart from selective catheterization) or intrathecal route.
There is a risk of hypersensitivity, regardless of the dose administered.

4.4.1 Warnings

4.4.1.1. Lymphography

Pulmonary embolisation occurs in a majority of patients following lymphography with Lipiodol Ultra Fluid, due to a portion of the product temporarily embolizing the pulmonary capillaries. Clinical evidence of such embolisation is infrequent, usually immediate however possibly delayed from a few hours to days, and usually of a transient nature. For this reason the doses should be adapted or the examination itself cancelled in subjects with impaired lung function, cardiorespiratory failure, or pre-existing right –sided cardiac overload, in particular elderly patients.
The injected dose of Lipiodol Ultra Fluid must be also reduced after chemotherapy or radiotherapy, as the lymph nodes will be considerably reduced in volume and will only take up a small amount of the contrast medium. Radiological or radioscopic monitoring during the injection is recommended. The occurrence of pulmonary invasion may be minimized if radiographic confirmation of intralymphatic (rather than venous) injection is secured, and the procedure discontinued when the medium becomes visible in the thoracic duct or the presence of lymphatic obstruction is noticed.

4.4.1.2. Hypersensitivity

All iodinated contrast agents can lead to minor or major hypersensitivity reactions, which can be life-threatening. These hypersensitivity reactions are of an allergic nature (known as anaphylactic reactions if they are serious) or a non-allergic nature. They can be immediate (occurring within 60 min) or delayed (not occurring until up to 7 days later). Anaphylactic reactions are immediate and can be fatal. They are dose-independent, can occur right from the first administration of the product, and are often unforeseeable.
The risk of a major reaction means that the equipment needed for emergency resuscitation must be immediately to hand.
Patients who have already experienced a reaction after a previous administration of Lipiodol Ultra Fluid or who have a history of iodine hypersensitivity are at increased risk of another reaction on readministration of the product and are thus regarded as at-risk patients.
The injection of Lipiodol Ultra Fluid may aggravate symptoms of an existing asthma. In patients with asthma unbalanced by the treatment, the decision to use Lipiodol Ultra Fluid must be made after careful evaluation of the risk/benefit ratio.

4.4.1.3. Thyroid

Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism in predisposed patients. Patients at risk are those with latent hyperthyroidism and those with functional thyroid autonomy. Iodism occurs more frequently with Lipiodol Ultra Fluid than with water-soluble organic iodine derivatives.
Lymphography saturates the thyroid with iodine for several months and any thyroid exploration should be performed before the radiological examination.


4.4.1.4. Chemoembolisation

Trans-Arterial Chemo-Embolisation is not recommended in patients with decompensated liver cirrhosis (Child-Pugh ≥8), advanced liver dysfunction, macroscopic invasion and/or extra-hepatic spread of the tumour.
Hepatic intra-arterial procedures can cause an irreversible liver insufficiency in patients with serious liver malfunction and/or undergoing close multiple sessions. More than 50% liver replacement with tumour, bilirubin level greater than 2 mg/dL, lactate dehydrogenase level greater than 425 mg/dL, aspartate aminotransferase level greater than 100 IU/L and decompensated cirrhosis have been described as associated with increased post-procedural mortality.
Oesophageal varices must be carefully monitored as they can rupture immediately after treatment. If a risk of rupture is demonstrated, endoscope sclerotherapy/ligature should be performed before the Trans-Arterial Chemo-Embolisation procedure.
Iodinated contrast agent induced renal insufficiency must be systematically prevented by correct rehydration before and after the procedure.
The risk of superinfection in the treated area is normally prevented by administration of antibiotics.

4.4.1.5. Embolisation with surgical glues

Early polymerisation reaction can occasionally occur with Lipiodol Ultra-Fluid and any surgical glue or any batch of glue. Before using new batches of Lipiodol Ultra-Fluid or surgical glue the compatibility between the Lipiodol Ultra-Fluid and glue must be checked in vitro.

4.4.2 Precautions for use

4.4.2.1. Hypersensitivity

Before the examination:
– identify patients at risk through precise questioning about their history.
– corticosteroids and H1 antihistamines have been proposed as premedication in patients at greatest risk of intolerance reactions (those known to be intolerant to a contrast agent). They do not prevent the occurrence of severe or fatal anaphylactic shock, however.
Throughout the examination, it is necessary to ensure the following:
– medical monitoring
– maintenance of venous access
After the examination:
– After administration of a contrast agent, the patient must be kept under observation for at least 30 min, as most of the serious undesirable effects occur within this period.
The patient must be warned of the possibility of delayed reactions (occurring up to 7 days after administration) (cf. section 4.8 Undesirable effects).

4.4.2.2. Thyroid

To prevent any metabolic disorder, possible thyroid risk factors must be determined. If administration of an iodised contrast agent is planned in such patients at risk, thyroid function must be determined before the examination.

4.4.2.3. Chemoembolisation/Embolisation

Iodinated contrast agents can induce a transient alteration in renal function or worsen pre-existing renal insufficiency. Preventive measures include:
• Identify at-risk patients, i.e. with dehydration or renal insufficiency, diabetes, severe heart failure, monoclonal gammopathy (multiple myeloma, Waldenstrom’s macroglobulinemia), a history of renal failure after iodinated contrast agent administration, children under one year of age and elderly subjects with atheroma.
• Hydrate before and after the procedure.
• Avoid combinations with nephrotoxic medicines. If this cannot be avoided, laboratory monitoring of renal function must be intensified. The medicines concerned include aminoglycosides, organoplatinum compounds, high doses of methotrexate, pentamidine, foscarnet and certain antiviral agents [aciclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir], vancomycin, amphotericin B, immunosuppressants such as cyclosporine or tacrolimus, ifosfamide)
• Allow at least 48 hours between two radiological examinations or procedure with injection of iodinated contrast agents, or postpone any new one until renal function returns to baseline.
• Prevent lactic acidosis in diabetics treated with metformin, by monitoring serum creatinine levels. Normal renal function: treatment with metformin must be suspended before contrast agent injection and for at least 48 hours after or until normal renal function is restored. Abnormal renal function: metformin is contraindicated. In case of emergency: if the examination is mandatory, precautions must be taken, i.e. metformin discontinuation, hydration, monitoring of renal function and checking for signs of lactic acidosis.
• Cardiovascular and/or pulmonary co-morbidities should be assessed before initiation of a Trans-Arterial Chemoembolisation procedure.

4.4.2.4. Miscellaneous

When injected into certain fistulae, great care should be taken to avoid penetration of vascular channels with the risk of oil embolism.
Care should be taken not to inject the product into an area affected by haemorrhage or trauma.

4.5 Interaction with other medicinal products and other forms of interaction

Drug-to-drug interaction

  • Metformin

Lactic acidosis triggered by impaired renal function may be induced by intra-arterial administration of Lipiodol Ultra Fluid in diabetic patients. For patients scheduled to undergo embolisation or chemoembolisation, treatment with metformin must be suspended 48 hours before the investigation and only restarted 2 days after the radiological examination.

Combinations that need to be taken into account

  • Beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers

These medicines reduce the effectiveness of the cardiovascular mechanisms that compensate for blood-pressure disturbances: the doctor should be informed about these prior to the administration of Lipiodol Ultra Fluid and have resuscitation equipment at hand.

  • Diuretics

In the event of dehydration provoked by diuretics, the risk of acute renal failure is increased, especially when high doses of iodinated contrast agents are used.
Precautions for use: re-hydration before intra-arterial administration of Lipiodol Ultra Fluid (embolisation or chemoembolisation).

  • Interleukin II

The risk of developing a reaction to the contrast agents is increased in the event of previous treatment with interleukin II (IV route): skin rash or, more rarely, hypotension, oliguria, or even renal failure.


Interference with diagnostic tests.
As Lipiodol Ultra Fluid remains in the body for several months, thyroid diagnostic results can be falsified for up to two years after lymphography.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of Lipiodol Ultra-Fluid during pregnancy has not been demonstrated. The use of Lipiodol Ultra-fluid during pregnancy causes iodine transfer which probably interferes with the thyroid function of the foetus. Although this anomaly is transitory it produces the potential risk of brain damage and permanent hypothyroidism, and therefore requires supervision of thyroid function and careful medical monitoring of the neonate.
Consequently, Lipiodol Ultra-Fluid must only be used in pregnancy if absolutely necessary and under strict medical supervision.
Also Lipiodol Ultra-Fluid must not be used for hysterosalpingography when pregnancy is suspected or confirmed.

Lactation

Pharmacokinetic studies show significant excretion of iodine in breast milk following intramuscular administration of Lipiodol Ultra-Fluid. Iodine has been shown to pass into the vascular bed via the digestive tract of breastfeeding infants and this could interfere with their thyroid function. Consequently, if Lipiodol Ultra-Fluid is to be used, breastfeeding should be interrupted or the neonate’s thyroid function should be checked more frequently.

4.7 Effects on ability to drive and use machines

The effects on the ability to drive and to use machines have not been investigated

4.8 Undesirable effects

Most adverse effects are dose-related and dosage should therefore be kept as low as possible.
The use of Lipiodol Ultra Fluid causes a foreign body reaction with the formation of macrophages and foreign-body giant cells and the occurrence of sinus catarrh, plasmacytosis and subsequent connective tissue changes in the lymph nodes. Healthy lymph nodes tolerate the resulting reduced transport capacity. In previously damaged or hypoplastic lymph nodes, these changes can exacerbate the existing lymphostasis.

Hypersensitivity reactions are possible. These reactions may involve one or more effects, occurring concomitantly or successively, and usually including cutaneous, respiratory and/or cardiovascular manifestations, each of which can be a warning sign of incipient shock and, in very rare instances, can even prove fatal.
In lymphography

An increase of temperature followed by fever with temperature of 38 to 39°C may be observed during the 24 hours after the exam.
Oil microemboli can occur with or without clinical symptoms. In very rare cases, they may resemble organic emboli in appearance and size. They appear as punctiform or flat opacities on X ray images of the lungs
Transient increases in temperature may occur. Oil microemboli occur more frequently after overdose of the contrast agent or excessively rapid infusion. They are favoured by anatomic abnormalities such as lymph-venous fistulae or decreased lymph node uptake capacity (in the elderly or after radiotherapy or cytostatic therapy).
Patients with cardiac right-to-left shunt and those with a massive pulmonary embolism are particularly at risk of cerebral oil microemboli.

In hysterosalpinography

Transitory fever reactions with temperature between 37 and 38°C accompanied by pelvic pain are frequent. Episodes of salpingitis or pelvic peritonitis have been reported after the exam in case of latent infection. Granuloma type tissue reactions are rare but could be serious during the exam as they produce a risk of perforation.
Hypothyroidism may also occur especially in patient with subclinical hypothyroidism.

In sialography

A secondary inflammation reaction can sometimes occur with functional glandular paralysis (salivary duct inflammation) which disappear within 48 hours.

In chemoembolisation

Most of the adverse reactions are not caused by Lipiodol Ultra-Fluid itself but are due to chemotherapy drugs or the embolisation itself.
The most frequent adverse reactions of the TACE treatment are post-embolisation syndrome (fever, abdominal pain, nausea, vomiting and transitory changes in liver function).

Embolisation with surgical glues

Specific adverse reactions directly related to LIPIODOL ULTRA-FLUID have not been reported.

In endocrinology:

Hyperthyroidism (see Section 4.4).
The undesirable effects are presented in the table below, by system organ class and by frequency using the following categories: very common (≥ 1/10), common (≥1/100 to 1<1/10), uncommon (≥1/1000 to 1<1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System organ classFrequency: undesirable  effect
Immune system disordersFrequency not known: Hypersensitivity, anaphylactic reaction, anaphylactoid reaction
Endocrine disorders Frequency not known: Hypothyroidism, hyperthyroidism, thyroiditis
Nervous system disordersFrequency not known: Cerebral embolism
Eye disordersFrequency not known: Retinal vein thrombosis
Vascular disordersFrequency not known: Lymphoedema aggrava-tion
Respiratory, thoracic and mediastinal disordersFrequency not known: Pulmonary embolism, dyspnea, cough
 Gastrointestinal disordersFrequency not known: Vomiting, diarrhoea, nausea
Hepatobiliary disorders Frequency not known: Hepatic vein thrombosis
General disorders and administration site conditionsFrequency not known: Granuloma, fever, pain

Undesirable effects in children
The expected nature of the undesirable effects connected with Lipiodol Ultra Fluid is the same at that of the effects reported in adults. Their frequency cannot be estimated from the available data.

4.9 Overdose

Overdose may lead to respiratory, cardiac or cerebral complications, which can potentially be fatal. Microembolisms may occur more frequently in the context of overdose.
The total dose of Lipiodol Ultra-Fluid administered must not exceed 20 mL.
The treatment of overdose is directed toward a prompt initiation of symptomatic treatment and support of all vital functions. Sites performing contrast medium examinations must be equipped with medicines and equipment for emergency aid.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: X-ray contrast media, iodinated; ATC code: V08A D01.
Water-insoluble iodinated contrast medium.

5.2 Pharmacokinetic properties

After intralymphatic administration, the preparation enters the blood; on reaching the liver and lungs, the oil droplets are decomposed in the pulmonary alveoli, the spleen and the fatty tissues.

After being taken up by tissues and reservoir organs, Lipiodol is released from these over a few days, a few months or possibly a few years. This is a continuous and regular process; iodine can be detected in the urine as long as the contrast medium is visible in the X-ray pictures.

After intramuscular administration, part of the oil is accumulated in the muscles and adjacent tissues. From the other part, the iodine is released by metabolism, and the body starts using it to compensate for the iodine deficiency of the thyroid gland.

Iodine is extensively eliminated with the urine, in which it soon appears (a few hours after injection), but its elimination continues over several months.

In adults, the elimination of iodine with the urine takes 3-5 years to drop to a value of 50 μg a day.

After selective intraarterial injection, iodine is mainly eliminated in urines. Lipiodol Ultra-Fluid is significantly more concentrated in the tumoral tissue than in the adjacent healthy tissue, especially in the case of hepatocellular carcinoma.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicology, genotoxicity and toxicity to reproduction and development.

 

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lipiodol Ultra-Fluid does not contain excipients.

6.2 Incompatibilities

Other medicinal products must not be mixed with Lipiodol Ultra Fluid.
Lipiodol Ultra Fluide has been shown to dissolve polystyrene; for this reason, disposable syringes made from this material must not be used to administer this preparation.

6.3 Shelf-life

3 years

6.4 Special precautions for storage

May vary depending on the country
– Do not store above 25°C.
– Store in the original packaging, protected from light.

6.5 Nature and content of container

10 mL glass ampoules.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 DATE OF REVISION

11th August 2015

Indications, volumes and presentations may differ from country to country. Please refer to the local Summary of Product Characteristics.

Reporting of suspected adverse reactions is important as it helps to continuously assess the benefit-risk balance. Therefore, Guerbet encourages you to report any adverse reactions to your health authorities or to our local Guerbet representative

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