Lipiodol Ultra-Fluide Warnings

Lymphography: Pulmonary embolism occurs in most patients undergoing lymphography with injection of LIPIODOL ULTRA-FLUIDE, as part of the product temporarily embolises the pulmonary capillaries. It is uncommon for this embolism to be manifested clinically; should this occur, the signs are immediate (though they may appear several hours or even several days after administration) and are usually transient. For this reason, doses must be adjusted or the examination cancelled in subjects with impaired respiratory function, cardio-respiratory failure or right ventricular overload, particularly if the patient is elderly. Doses must also be reduced after anti-neoplastic chemotherapy or radiotherapy because lymph nodes shrink significantly and retain very little contrast agent. The injection should be carried out with radiological or endoscopic guidance. Pulmonary invasion can be reduced to the minimum by confirming radiologically that the injection is strictly intralymphatic (and not intravenous) and by discontinuing the examination as soon as the contrast agent becomes visible in the thoracic duct or as soon as lymphatic obstruction is observed.
Hypersensitivity: All iodinated contrast agents may cause minor or major hypersensitivity reactions that may be life-threatening. These hypersensitivity reactions may be either allergic (described as anaphylactic reactions when serious) or non-allergic. They may be immediate (withing 60 minutes) or delayed (up to 7 days). Anaphylactic reactions occur immediately and can be fatal. They are independent of the dose, can occur after even the first dose of the product, and are often unpredictable.
Emergency resuscitation equipment must be immediately available due to the risk of a major reaction.
Patients who have previously experienced a reaction during administration of LIPIODOL ULTRA-FLUIDE or who have a history of hypersensitivity to iodine are at higher risk for another reaction if the product is again administered.
They are thus considered to be patients at risk.
Injection of LIPIODOL ULTRA-FLUIDE may exacerbate symptoms of asthma. In patients whose asthma is not controlled by treatment, the decision to use LIPIODOL ULTRA-FLUIDE must be based on a careful consideration of the benefit-to-risk ratio.
Thyroid: Because of the free iodine content in iodinated contrast agents, they may modify thyroid function and cause hyperthyroidism in predispose patients. Patients at risk are those with latent hyperthyroidism or thyroid autonomy. Iodism occurs more commonly with LIPIODOL ULTRA-FLUIDE than with water-soluble organic iodine derivatives.
Lymphography saturates the thyroid with iodine for several months and consequently thyroid function tests must be carried out before the radiological examination.
Trans-Arterial Chemo-Embolisation: 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 synthetically prevented by correct rehydration before and after the procedure.
The risk of superinfection in the treated area is normally prevented by administration of antibiotics.