Between August 2009 and December 2013, Guerbet conducted a national non-interventional post-marketing surveillance (PMS) study with iobitridol (Xenetix®) in Germany. The aim of the PMS study was to gain additional information about the safety of iobitridol as well as its efficacy in daily practice using the most up-to-date imaging and administration techniques.

A two-page report form was used to record the data. The report form included 9 sections: patient information (age, sex, height, weight), known risk factors (bronchial asthma, CNS disorder, coronary heart disease, diabetes mellitus, diuretics, heart failure, history of a reaction to a contrast agent, hypertension, known allergies, pheochromocytoma, poor general condition, severe liver dysfunction, sickle cell anemia, thyroid dysfunction, water balance/electrolyte metabolism disturbed), impaired renal function, premedication, type of examination, injection of contrast agent, imaging quality, diagnostic value and safety. The data was descriptively...

A total of 94,960 examinations with iobitridol (53.1% male, 46.9% female, mean (±SD) age 58.8 ± 15.6 years) were carried out in 168 centres, predominantly CTexaminations (49.3%) or IV urography (48.8%). The most common CT examinations were of the abdomen/pelvis (55.9%), thorax (34.5%) and head (14.0%) [Fig. 1]. For the CT examinations, the mean (±SD) volume of contrast agent administered was 89.9 ± 19.9 mL with an injected volume between 50 and 120 mL in 90% of the patients [Fig. 2]. Patients who underwent IV...

Adverse events occurred in 0.5% of patients. The most common adverse events were nausea, urticaria, dizziness and rash. Serious adverse events were observed in 0.03% of patients. Examination with iobitridol enabled a diagnosis to be made in 99.6% of all cases (CT examination 99.9%, IV urography 99.3%), with excellent or good imaging quality (96.6%). The results demonstrate that iobitridol (Xenetix®) is a safe contrast agent that enables diagnosis with optimal imaging quality.

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 80, 357-362 (2011) Wendt-Nordahl G., et al. Intravenous contrast media in uroradiology: Evaluation of safety and tolerability in almost 50,00 patients. Med Princ Pract 15 (5), 358 – 361 (2006) Vogl TJ., et al. Safety of iobitridol in the general population and at-risk patients. Eur Radiol 16 (6), 1288-1297 (2006) Petersein J., et al. Results of the safety...