Gadobenate dimeglumine

Kirchin MA, Pirovano GP, Spinazzi A (1998) Gadobenate dimeglumine (Gd-BOPTA) an overview. Invest Radiol 33 798-809... 

Gd(B0PTA)(H20)]2- Gadobenate dimeglumine MultiHance3 Bracco (Italy) Hepatobiliary/ extracellular... 

Spinazzi, A., Lorusso, V., Pirovano, G, and Kirchin, M. (1999) Safety, tolerance, biodistribution, and MR imaging enhancement of the liver with gadobenate dimeglumine results of clinical pharmacologic and pilot imaging studies in nonpatient and patient volunteers. Academic Radiology, 6, 282-291. 

Petersein, 1., Spinazzi, A., Giovagnoni, A., et al. (2000) Focal liver lesions evaluation of the efficacy of gadobenate dimeglumine in MR imaging - A multicenter phase III clinical study. Radiology, 215, 727-736. 

Kim, Y.K., Lee, J.M., and Kim, C.S. (2004) Gadobenate dimeglumine-enhanced liver MR imaging value of dynamic and delayed imaging for the characterization and detection of focal liver lesions. European Radiology, 14, 5-13. 

Pediconi, R, Catalano, C., Occhiato, R., et al. (2005) Breast lesion detection and characterization at contrast-enhanced MR mammography gadobenate dimeglumine versus gadopentetate dimeglumine. Radiology, 237, 45-56. 

Knopp, M.V., Bourne, M.W., Sardanelli, R, et al, (2003) Gadobenate dimeglumine-enhanced MRI of the breast analysis of dose response and comparison with gadopentetate dimeglumine. American Journal of... 

Sardanelli, R, lozzelli. A., Fausto, A., et al. (2005) Gadobenate dimeglumine-enhanced MR imaging breast vascular maps association between invasive cancer and ipsilateral increased vascularity. Radiology, 235, 791-797. 

In 74 patients over the age of 18 years with possible metastatic brain disease, a total cumulative dose of 0.2 mmol/kg of gadobenate dimeglumine injected intravenously over 20 minutes was safe and enhanced the assessment of brain secondaries (8). 

The safety and efficacy of gadobenate dimeglumine in phase 1, 2, and 3 studies have been reviewed in 732 patients, of whom 168 received 0.05 mmol/kg and 564 received 0.1 mmol/kg (9). The overall incidence of adverse events was 14% with the lower dose and 9.9% with the higher dose. The vast majority of events were mild, transient, and self-limiting. There were no sex-, age-, or dose-related differences and no clinically important effects on vital signs or laboratory parameters. The most common adverse events were hypertension (1.37%), nausea (1.09%), tachycardia (0.96%), and albuminuria (0.75%). The authors concluded that gadobenate... 

The safety of gadobenate dimeglumine has been confirmed in phase 2 and phase 3 studies in Japan (10,11). The overall adverse reaction rate was 3.5-5% and all the reactions were mild or moderate. There were no differences in the rates of adverse reactions with different dosage regimens (0.05-2.0 mmol/kg). 

A safety evaluation of gadobenate dimeglumine in patients with renal impairment has also been reported... 

The safety of gadobenate dimeglumine has been evaluated in 2367 adults aged 18-88 years and 173 children. The overall incidence of adverse events was 20%. Events related to the contrast agent were reported in 15 % of the adults. Most of the adverse events were mild and transient and resolved spontaneously. Headache, injection site reactions, nausea, taste disturbance, and vasodilatation were the most common, with frequencies of 1.0-2.6%. Serious adverse events potentially related to the contrast agent were reported in 0.2%. These events included laryngospasm, which developed 10 minutes after the contrast injection in a 51-year-old woman, severe vomiting in a 5-year-old child, and pulmonary edema in a 65-year-old patient. 

Gadobenate dimeglumine (intravenous bolus injection of 0.05 mmol/kg) was well tolerated by 103 patients (mean age 56 years) with acute myocardial infarction... 

Minor adverse effects in 27 patients included injection site reactions (13%), paresthesia (6.8%), dry mouth (6.8%), taste disturbance (2.9%), and headache (1.9%). The authors concluded that the use of a bolus dose of gadobenate dimeglumine 0.05 mmol/kg up to 6 days after acute myocardial infarction is safe. 

The safety of gadobenate dimeglumine has been evaln-ated in 16 snbjects with liver impairment, 11 of whom (mean age 48 years) received gadobenate dimeglnmine (0.1 mmol/kg) intravenously and five of whom (mean age 42 years) received placebo (36). There were no important adverse effects and no significant changes in laboratory parameters. The pharmacokinetics of the contrast agent were not different from those with normal Uver fnnction. 

Kirchin MA, Pirovano G, Venetianer C, Spinazzi A. Safety assessment of gadobenate dimeglumine (MultiHance) extended clinical experience from phase I studies to postmarketing surveillance. J Magn Reson Imaging 2001 14(3) 281-94. 

Tanimoto A, Kuwatsuru R, Kadoya M, Ohtomo K, Hirohashi S, Murakami T, Hiramatsu K, Yoshikawa K, Katayama H. Evaluation of gadobenate dimeglumine in hepatocellular carcinoma results from phase II and phase III clinical trials in Japan. J Magn Reson Imaging 1999 10(3) 450-60. 

Swan SK, Lambrecht LJ, Townsend R, Davies BE, McCloud S, Parker JR, Bensel K, LaFrance ND. Safety and pharmacokinetic profile of gadobenate dimeglumine in subjects with renal impairment. Invest Radiol 1999 34(7) 443-8. 

Cherryman GR, Pirovano G, Kirchin MA. Gadobenate dimeglumine in MRI of acute myocardial infarction results of a phase III study comparing dynamic and delayed contrast enhanced magnetic resonance imaging with EKG, (201)T1 SPECT, and echocardiography. Invest Radiol 2002 37(3) 135-45. 

Kroencke TJ, Wasser MN, Pattynama PM, Barentsz JO, Grabbe E, Marchal G, Knopp MV, Schneider G, Bonomo L, Pennell DJ, del Maschio A, Hentrich HR, Dapra M, Kirchin MA, Spinazzi A, Taupitz M, Hamm B. Gadobenate dimeglumine-enhanced MR angiography of the abdominal aorta and renal arteries. AJR Am J Roentgenol 2002 179(6) 1573-82. 

La Ferla R, Dapra M, Hentrich HR, Pirovano G, Kirchin MA. Gadobenate dimeglumine (Multihance) in contrast-enhanced magnetic resonance angiography. Acad Radiol 2002 9(Suppl 2) S409-11. 

Davies BE, Kirchin MA, Bensel K, Lorusso V, Davies A, Parker JR, Lafrance ND. Pharmacokinetics and safety of gadobenate dimeglumine (multihance) in subjects with impaired Uver function. Invest Radiol 2002 37(5) 299-308. 

Del Frate C, Bazzocchi M, Mortele KJ et al (2002) Detection of liver metastases comparison of gadobenate dimeglumine-enhanced and ferumoxides-enhanced MR imaging examinations. Radiology 225 766-772... 

Grazioli L, Morana G, Kirchin MA et al (2003) MRI of focal nodular hyperplasia (FNH) with gadobenate dimeglumine (Gd-BOPTA) and SPIO (ferumoxides) an intra-individual comparison. J Magn Reson Imaging 17 593-602... 

The safety of gadobenate dimeglumine in a pediatric population was investigated in a retrospective study of 200 in-hospital patients with 336 contrast-enhanced studies. The patients were monitored for af least 24 h after administration. No adverse events were observed in all of the patients including patients with multiple administrations [40 ]. 

---