Backed by Guerbet’s continuous commitment to the field of contrast media, Xenetix® provides you with a large panel of Real World Evidence (RWE)1-5 to help advance your real-world imaging.
Xenetix® is a non-ionic monomeric, iodinated contrast agent associated with balanced and stabilized hydrophilicity, low osmolality, low viscosity and high water-solubility. It is used in radiological examinations, and particularly in CT.
Xenetix® is supplied in 3 different concentrations: 250, 300 and 350 mg I/mL.
Xenetix® is approved for use in adults and children in a wide range of indications, including intravenous (IV) urography, head and whole body CT and intra-arterial (IA) or IV digital subtraction angiography (DSA) and can be used via several routes of administration; local prescribing information should be consulted.
It is approved in more than 60 countries.
Not all the concentrations and indications may be available in your country. Indication may vary from children to adult population Please check with your local Guerbet representative for more information.
Clinical safety proven by Real World Evidence (1-5)
Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD (Real World Data). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective). RWE complements clinical trials data by providing insights that trials can’t. This combination could guide your diagnosis/ treatment decision on what works best on specific patient populations.
Safety data in 5 large scale post-marketing surveillance studies including more than 400,000 patients and clinical trials show that Xenetix® is well tolerated in general and specific populations.(1-5)
Xenetix® is well tolerated and safe for use in patients of a wide range of ages, including patients with risk factors for reactions to contrast agents[1-5] although local clinical guidelines and the local Summary of Product Characteristics (SmPC) should always be taken into account.
SAFETY IN SPECIAL PATIENT POPULATIONS
The use of Xenetix® was evaluated in a broad range of patient populations coming from a wide age range.
Xenetix® was found to be well tolerated:
- In paediatric population: In one study, 3 (4.2%) patients younger than 15 years of age experienced a total of 3 adverse events: vomiting, nausea and urticaria. None was serious.[2]
- In at-risk patients: In one study, the incidence of adverse events (1.4%) was higher in at-risk patients than in those with no pre-existing risk factors[2]. The main risk factors identified in connection with adverse events were history of reaction to contrast agents, allergies or asthma, hypotension or hypertension[2]. In another post-marketing surveillance study, significantly more patients with asthma/allergies (21.9% of 1,849 patients) or renal insufficiency (defined as creatinine level > 1.5 mg/dL or 133 μmol/L ;10.9% of 950 patients) experienced an adverse event in comparison to the overall population[3].
In a recent post-marketing study, the prevalence of AEs was significantly higher in patients with at least one risk factor (0.6% vs 0.4%, P < 0.05), and with history of AE after CM administration (2.5% vs 0.5%, P < 0.05).[5]
- In elderly patients: When compared with patients aged ≤ 39 years, the incidence of adverse events was lower in patients aged ≥ 60 years[1] or ≥ 70 years[2]; respective rates of adverse events were 0.9% versus 1.7% (p < 0.001 [excluding «feeling of warmth»][1]) in Petersein’s study and 0.63% versus 1.40% in Vogl’s study[2]. In Gorodetski study the prevalence of adverse events was higher in patients aged <60 years (0.3%) than ≥ 60 years (0,7%).[5] This difference was possibly attributable to a higher immunocompetence in younger patients[1].
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Diagnostic Imaging Solutions For RadiologySources and references
- Petersein J., et al., Results of the safety and efficacy of iobitridol in more than 61,000 patients. Eur Radiol, 2003. 13(8): p. 2006- 2011. Methodology: 61,754 patients undergoing routine examination (CT, IVU, DSA, conventional angiography and phlebography). Patients aged from a few weeks to 97 years.
- Vogl T.J., et al., Safety of iobitridol in the general population and at-risk patients. Eur Radiol, 2006. 16(6): p. 1288-1297. Methodology: 52,057 patients undergoing routine examination (CT, IVU, DSA, conventional angiography and phlebography). Patients aged from 4 to 98 years with 72 patients less than 15 years of age and 28549 patients aged 60 and above Pre-existing risk factors were present in 27% of patients).
- Wendt-Nordahl G., et al., Intravenous contrast media in uroradiology: Evaluation of safety and tolerability in almost 50,000 patients. Med Princ Pract, 2006. 15(5): p. 358-361. Methodology: 49,975 patients undergoing IVU (98 %) or other urological examinations (2 %). Patients aged from 3 to 101 years. Patients were considered at high risk for 7.4% of the total recruitment.
- Maurer M., et al., Safety and tolerability of iobitridol in general and in patients with risk factors: results in more than 160,000 patients. Eur J Radiol, 2011. 80: p. 357-62. Methodology: 160,639 patients undergoing routine examination (IVU, CT). Patients aged from 5 to 97 years. At least one risk factor was reported in 21.8% of patients.
- Gorodetski B., et al., Safety Analysis of Iobitridol as a Nonionic Contrast Medium: A Postmarketing Multicenter Surveillance Study With 94,960 Patients Almost 20 Years After Introduction. Invest Radiol, 2020. 55(3): p. 144-152. Methodology: 94,960 patients undergoing routine examination (CT,IVU, phlebography, angiography, and angiocardiography). At least one risk factor was reported in 30.8% of patients.
P21000539 – April 2021