Toxicological safety evaluation of gadobutrol

Investigative Radiology

Volumn 47, Issue 11, 2012, Pages 611-623

  Wack, Christiane ^a   Steger Hartmann, Thomas ^a   Mylecraine, Louis ^b   Hofmeister, Rainer ^a  

^a BAYER PHARMA AG   (Germany)

^b Triskelion Toxicology LLC   (United States)

Author keywords

central nervous system; contrast agent; Gadobutrol; kidneys; magnetic resonance imaging; MRI; nephrogenic systemic fibrosis; preclinical safety evaluation; vacuolization

Indexed keywords

GADOBUTROL;

ACUTE TOXICITY; ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DEVELOPMENTAL TOXICITY; DOG; DOSE CALCULATION; DRUG ANTIGENICITY; DRUG SAFETY; DRUG TOLERANCE; FEMALE; GENOTOXICITY; HAPLORHINI; HUMAN; KIDNEY FUNCTION; KIDNEY TUBULE EPITHELIUM; LETHALITY; MALE; NONHUMAN; ORGANOGENESIS; PRIORITY JOURNAL; RABBIT; RAT; REPEATED DRUG DOSE; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; RODENT; STANDARD;

EID: 84867250047     PISSN: 00209996     EISSN: 15360210     Source Type: Journal    
DOI: 10.1097/RLI.0b013e318263f128     Document Type: Article

References (33)

1. Frenzel T, Lengsfeld P, Schirmer H, et al. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37 degrees C. Invest Radiol. 2008;43:817-828.
2. Schmitt-Willich H. Stability of linear and macrocyclic gadolinium based contrast agents. Br J Radiol. 2007;80:581-582.
3. Löwe A, Breuer J, Palkowitsch P. Evaluation of the effect of two gadoliniumcontaining contrast-enhancing agents, gadobutrol and gadoxetate disodium, on colorimetric calcium determinations in serum and plasma. Invest Radiol. 2011;46:366-369.
4. Staks T, Schuhmann-Giampieri G, Frenzel T, et al. Pharmacokinetics, dose proportionality, and tolerability of gadobutrol, after single intravenous injection in healthy volunteers. Invest Radiol. 1994;29:709-715.
5. Vogler H, Platzek J, Schuhmann-Giampieri G, et al. Pre-clinical evaluation of gadobutrol: a new, neutral, extracellular contrast agent for magnetic resonance imaging. Eur J Radiol. 1995;21:1-10.
6. Bellin MF. MR contrast agents, the old and the new. Eur J Radiol. 2006;60: 314-323.
7. Durmus T, Schilling R, Doeblin P, et al. Gadobutrol for magnetic resonance imaging of chronic myocardial infarction. Invest Radiol. 2012;47:183-188.
8. Katakami N, Inaba Y, Sugata S, et al. Magnetic resonance evaluation of brain metastases from systemic malignancies with two doses of gadobutrol 1.0 M compared with gadoteridol. Invest Radiol. 2011;46:411-418.
9. Pietsch H, Lengsfeld P, Jost G, et al. Long-term retention of gadolinium in the skin of rodents following the administration of gadolinium-based contrast agents. Eur Radiol. 2009;19:1417-1424.
10. Sieber MA, Lengsfeld P, Frenzel T, et al. Preclinical investigation to compare different gadolinium-based contrast agents regarding their propensity to release gadolinium in vivo and to trigger nephrogenic systemic fibrosis-like lesions. Eur Radiol. 2008;18:2164-2173.
11. Pietsch H, Lengsfeld P, Steger-Hartmann T, et al. Impact of renal impairment on long-term retention of gadolinium in the rodent skin following the administration of gadolinium-based contrast agents. Invest Radiol. 2009;44: 226-233.
12. Pietsch H, Pering C, Lengsfeld P, et al. Evaluating the role of zinc in the occurrence of fibrosis of the skin: a preclinical study. J Magn Reson Imaging. 2009;30:374-383.
13. Lang R, Reimann R. Studies for a genotoxic potential of some endogenous and exogenous sex steroids. I. Communication: examination for the induction of gene mutations using the Ames Salmonella/microsome test and the HGPRT test in V79 cells. Environ Mol Mutagen. 1993;21:272-304.
14. Reimann R, Kalweit S, Lang R. Studies for a genotoxic potential of some endogenous and exogenous sex steroids. II. Communication: examination for the induction of cytogenetic damage using the chromosomal aberration assay on human lymphocytes in vitro and the mouse bone marrow micronucleus test in vivo. Environ Mol Mutagen. 1996;28:133-144.
15. Maurer T,Weirich EG, Hess R. The optimization test in the guinea pig in relation to other predictive sensitization methods. Toxicology. 1980;15:163-171.
16. Harpur ES, Worah D, Hals PA, et al. Preclinical safety assessment and pharmacokinetics of gadodiamide injection, a new magnetic resonance imaging contrast agent. Invest Radiol. 1993;28(suppl 1):S28-S43.
17. Genda Y, Furuhama K, Kakihata K, et al. DW-7572 (caldiamide sodium) injection toxicity to rats by repeated intravenous injection for 4 weeks followed by a 4-week recovery period. J Toxicol Sci. 1993;21(suppl):765-783.
18. Steger-Hartmann T, Graham PB, Müller S, et al. Preclinical safety assessment of Vasovist (gadofosveset trisodium), a new magnetic resonance imaging contrast agent for angiography. Invest Radiol. 2006;41:449-459.
19. Döhr O, Hofmeister R, Treher M, et al. Preclinical safety evaluation of Gd-EOBDTPA (Primovist). Invest Radiol. 2007;42:830-841.
20. Battenfeld R, Khater A el-R, Drommer W, et al. Ioxaglate-induced light and electron microscopic alterations in the renal proximal tubular epithelium of rats. Invest Radiol. 1991;26:35-39.
21. Simon G, Chatelanat F, Falbriard A. Experimental nephrosis due to inulin: light and electron microscopic studies. Lab Invest. 1964;13:1381-1393.
22. Maunsbach AB, Madden SC, Latta H. Light and electron microscopic changes in proximal tubules of rats after administration of glucose, mannitol, sucrose, or dextran. Lab Invest. 1962;11:421-432.
23. Merski JA, Meyers MC. Light-and electron-microscopic evaluation of renal tubular cell vacuolation induced by administration of nitrilotriacetate or sucrose. Food Chem Toxicol. 1985;23:923-930.
24. Taggart WR, Thibodeau GA, Swanson RN. Mannitol induced renal alterations in rabbits. S D J Med. 1968;21:30-34.
25. Stuart FP, Torres E, Fletcher R, et al. Effects of single, repeated and massive mannitol infusion in the dog: structural and functional changes in kidney and brain. Ann Surg. 1970;172:190-204.
26. Engberg A. Effects of dextran 40 on the proximal renal tubule. Studies on transfer maxima of glucose and hippuran in the rat. Acta Chir Scand. 1976;142: 172-180.
27. Dickenmann M, Oettl T, Mihatsch MJ. Osmotic nephrosis: acute kidney injury with accumulation of proximal tubular lysosomes due to administration of exogenous solutes. Am J Kidney Dis. 2008;51:491-503.
28. Doborota M, Powell CJ, Holtz E, et al. Biochemical and morphological effects of contrast media on the kidney. Acta Radiol Suppl. 1995;399:196-203.
29. Morcos SK, Epstein FH, Haylor J, et al. Aspects of contrast media nephrotoxicity. Eur J Radiol. 1996;23:178-184.
30. Bayer Schering Pharma AG. Gadovist product information. 2010. Available at: http://www.bayerresources.com.au/resources/uploads/PI/file9345.pdf. Accessed October 24, 2011.
31. Runge VM. Safety of magnetic resonance contrast media. Top Magn Reson Imaging. 2001;12:309-314.
32. Voth M, Rosenberg M, Breuer J. Safety of gadobutrol, a new generation of contrast agents. Invest Radiol. 2011;46:663-671.
33. Schöbel C, Günzel P, Mü ller N. Preclinical studies with dimeglumine gadopentetate (Magnevist\) for human risk assessment. Adv MRZ Contrast. 1992; 1(suppl 1):2-14.