Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).
(Clinical Trial;Clinical Trial, Phase III;Journal Article;Multicenter Study)
The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.
Federle, MP; Chezmar, JL; Rubin, DL; Weinreb, JC; Freeny, PC; Semelka, RC; Brown, JJ; Borello, JA; Lee, JK; Mattrey, R; Dachman, AH; Saini, S; Harmon, B; Fenstermacher, M; Pelsang, RE; Harms, SE; Mitchell, DG; Halford, HH; Anderson, MW; Johnson, CD; Francis, IR; Bova, JG; Kenney, PJ; Klippenstein, DL; Foster, GS; Turner, DA
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