SmPC Xenetix®

Xenetix® 350, solution for injection (350 mgI/ml) ; Xenetix® 300, solution for injection (300 mgI/ml) ; Xenetix® 250, solution for injection (250 mgI/ml) – Composition per 100 ml : Xenetix® 350 : 76.78 g of iobitridol (corresponding to 35 g of iodine), Xenetix® 300 : 65.81 g of iobitridol (corresponding to 30 g of iodine), Xenetix® 250: 54.84 g of iobitridol (corresponding to 25 g of iodine) - Indications(**): this product is for diagnostic use only. Contrast agent for use in: Xenetix® 350 intravenous urography, whole body and cranial computed tomography, intravenous digital subtraction angiography, arteriography, angiocardiography, Sialography, Endoscopic retrograde cholangiopancreatography – Xenetix® 300: intravenous urography, whole body and head computed tomography, intravenous digital subtraction angiography, arteriography, angiocardiography, endoscopic retrograde cholangiopancreatography, arthrography, hysterosalpingography, herniography – Xenetix® 250: phlebography, whole body computed tomography, intra-arterial digital subtraction angiography, arteriography, endoscopic retrograde cholangiopancreatography – Posology and method of administration(*): the doses should be adapted to the examination and the territories intended to be opacified, as well as to the weight and renal function of the subject, particularly in children. –
Contraindications (*): hypersensitivity to iobitridol or any of the excipients, history of major immediate or delayed skin reaction (see undesirable effects) to Xenetix®, manifest thyrotoxicosis, hysterosalpingography during pregnancy. –
General comments for all iodinated contrast agents (*): There is a risk of allergic reactions regardless of the route of administration or the dose. In the absence of specific studies, myelography is not an indication for Xenetix®. All iodinated contrast media can cause minor or major reactions that can be life-threatening. They may occur immediately (within 60 minutes) or be delayed (within 7 days) and are often unpredictable. Because of the risk of major reactions, emergency resuscitation equipment should be available for immediate use - Before administering an iodinated contrast agent, it is important to ensure that the patient is not scheduled to undergo a scintigraphic examination or laboratory tests related to the thyroid or to receive radioactive iodine for therapeutic purposes. Administration of contrast agents via any route disrupts hormone concentrations and iodine uptake by the thyroid or by metastases of thyroid cancer, until urine iodine levels have returned to normal. Extravasation is a non-exceptional complication (0.04% to 0.9%) of intravenous injections of contrast media. More frequent with the high osmolar products, most of the injuries are minor, however severe injuries such as skin ulceration, tissue necrosis, and compartment syndrome may occur with any iodinated contrast medium. The risk and/or severity factors are patient-related (poor or fragile vascular conditions), and technique-related (use of a power injector, large volume). It is important to identify these factors, optimize the injection site and technique accordingly, and monitor the injection prior to, during and after the injection of Xenetix –
Special warnings and precautions for use (*): For at risk patients with:1) Intolerance to iodinated contrast agents: Prior the examination, at-risk patients should be identified by a precise screening of histories. During the procedure, the medical surveillance and permanent venous access must be maintained. After the examination the patient must be monitored for at least 30 minutes, since most serious adverse reactions occur within this time period and the patient must be informed of the possibility of delayed reactions (for up to seven days), 2) Severe cutaneous adverse reactions: At the time of initiation patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. Xenetix should be discontinued immediately upon suspicion of a severe hypersensitivity reaction. If the patient has developed a severe cutaneous adverse reaction with the use of Xenetix, Xenetix must not be re-administered in this patient at any time, 3) Renal insufficiency and/or hepatic insufficiency: Care should be taken in renal or hepatic impairment, diabetes or in patients with sickle cell disease, adequate hydration should be ensured in all patients before and after contrast media administration and particularly in patients with renal impairment or diabetes. 4) Asthma: Stabilisation of asthma is recommended before the injection of an iodinated contrast agent. Due to an increased risk of bronchospasm, special caution should be taken in patients do to suffered an asthmatic attack within eight days prior to the examination.5) Dysthyroidism: After iodinated contrast agent injection, particularly in patients with a goitre or a history of dysthyroidism, there is a risk either of a flare-up of hyperthyroidism or development of hypothyroidism. There is also a risk of hypothyroidism in neonates who have received, or whose mother has received, an iodinated contrast agent. Therefore, thyroid function in such neonates should be evaluated and closely monitored to ensure thyroid function is normal.6) Cardiovascular diseases: Careful weighing up of the risk-benefit ratio is necessary in these patients. 7) Central nervous system disorders: The benefit-to-risk ratio must be evaluated for each case: due to the risk of aggravation of neurological symptoms in patients with a transient ischaemic attack, acute cerebral infarct, recent intracranial haemorrhage, cerebral oedema, or idiopathic or secondary (tumour, scar) epilepsy and if the intra-arterial route is used in an alcoholic patient (acute or chronic alcoholism) and other drug-addicted subject. 8) Pheochromocytoma: Patients with pheochromocytoma may develop a hypertensive crisis after intravascular administration of a contrast agent and must be monitored prior to the examination. 9) Myasthenia: Administration of a contrast agent may worsen the symptoms of myasthenia gravis.10) Intensification of side effects: Adverse reactions related to iodinated contrast agent administration may
be intensified in patients showing pronounced agitation, anxiety and pain. Appropriate management such as sedation may be necessary.
Warnings and precautions for use specific to certain administration routes with appreciable systemic diffusion (*): - Products administered via the intra-uterine route (Xenetix 300): Contraindication: Pregnancy for hysterosalpingography-Special precautions for use: In the interview and with appropriate tests, systematically check for possible pregnancy in women of childbearing age. Exposure of the female genital routes to x-rays must be subject to careful evaluation of the benefit-to-risk ratio. In the event of inflammation or acute pelvic infection, hysterosalpingography can only be performed after a careful assessment of the benefit-to-risk ratio. - Risk of acute pancreatitis in the context of endoscopic retrograde pancreatography -Interaction with other medicinal products and other forms of interaction (*): beta-blocker substances, diuretics, metformin, radiopharmaceuticals, interleukin 2
Fertility, pregnancy and lactation (*)
Undesirable effects(*): Uncommon (1/1000 to <1/100): nausea, feeling hot - Rare (1/10 000 to <1/1 000): hypersensitivity , presyncope, tremor, paresthesia, vertigo, tachycardia, bradycardia, hypotension, dyspnoea, cough, throat tightness, sneezing, , vomiting, , angioedema, urticaria, erythema, pruritus, facial oedema, malaise, chills, injection site pain - Very rare (<1/10 000): anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, thyroid disorder, coma, seizure, confusional state, visual pathway disorders, amnesia, photophobia, blindness transient, somnolence, agitation, headache, hypoacusis, cardiac arrest, myocardial, infarction (more frequent after intracoronary injection), arrhythmia, ventricular fibrillation, angina pectoris, torsades de pointes, coronary arteriospasm, circulatory collapse, respiratory arrest, pulmonary oedema, bronchospasm, laryngospasm, laryngeal oedema, abdominal pain, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, rash maculo-papular (all as delayed hypersensitivity reactions), acute kidney injury, anuria, injection site necrosis following extravasation, injection site inflammation following extravasation, injection site oedema, blood creatinine increased -– Not known: transient neonatal hypothyroidism, dizziness, cyanosis, hypertension, drug reaction with eosinophilia and systemic symptoms (DRESS) - Compartment syndrome may be observed following extravasation
Overdose (*)Pharmacodynamic properties (*): Pharmacotherapeutic group: Water-soluble, nephrotropic radiology contrast medium with low osmolarity; ATC code: V08AB11. Presentation (**): Xenetix 250: 50 ml, 100 ml, 200 ml or 500 ml glass vials, Xenetix 300/350: 20 ml, 50 ml, 60 ml, 75 ml, 100 ml, 150 ml, 200 ml or 500 ml glass vials and 100 ml, 150 ml, 200 ml or 500 ml polypropylene bags. Marketing authorisation holder (*): Guerbet - BP 57400 - F-95943 Roissy CdG cedex – FRANCE. Information: tel: 33 (0) 1 45 91 50 00. Revision: January 2021.
(*) For complete information please refer to the local Summary of Product Characteristics
(**) Indications, volumes and presentations may differ from country to country.
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.