s cleared by glomerular filtration and is dialyzable.
Injection site reactions
Skin and soft tissue necrosis, thrombosis, fasciitis, and compartment syndrome requiring surgical intervention (e.g. compartment release or amputation) have occurred very rarely at the site of contrast injection or the dosed limb. Total volume and rate of MAGNEVIST Injection, extravasation of contrast agent, and patient susceptibility might contribute to these reactions. Phlebitis and thrombophlebitis may be observed generally within 24 hours after MAGNEVIST Injection and resolve with supportive treatment. Determine the patency and integrity of the intravenous line before administration of MAGNEVIST Injection. Assessment of the dosed limb for the development of injection site reactions is recommended.
Interference with Visualization of lesions visible with non-contrast MRI
As with any paramagnetic contrast agent, MAGNEVIST Injection might impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when MAGNEVIST MRI scans are interpreted without a companion non-contrast MRI scan.
Patient counseling information
Patients scheduled to receive MAGNEVIST Injection should be instructed to inform their physician if they are pregnant, breast feed, or have a history of renal insufficiency, asthma or allergic respiratory disorders.
LABORATORY TEST FINDINGS
Transitory changes in serum iron, bilirubin and transaminase levels were observed in clinical trials.
MAGNEVIST Injection does not interfere with serum and plasma calcium measurements determined by colorimetric assays.
CARCINOGENESIS, MUTAGENESIS AND IMPAIRMENT OF FERTILITY
Long term animal studies have not been performed to eva luate the carcinogenic potential of gadopentetate dimeglumine.
A comprehensive battery of in vitro and in vivo studies in bacterial and mammalian systems suggest that gadopentetate dimeglumine is not mutagenic or clastogenic and does not induce unscheduled DNA repair in rat hepatocytes or cause cellular transformation of mouse embryo fibroblasts. However, the drug did show some evidence of mutagenic potential in vivo in the mouse dominant lethal assay at doses of 6 mmol/kg, but did not show any such potential in the mouse and dog micronucleus tests at intravenous doses of 9 mmol/kg and 2.5 mmol/kg, respectively.
When administered intra-peritoneally to male and female rats daily prior to mating, during mating and during embryonic development for up to 74 days (males) or 35 days (females), gadopentetate caused a decrease in number of corpora lutea at the 0.1 mmol/kg dose level. After daily dosing with 2.5 mmol/kg suppression of food consumption and body weight gain (males and females) and a decrease in the weights of testes and epididymis were also observed.
In a separate experiment in rats, daily injections of gadopentetate dimeglumine over 16 days caused spermatogenic cell atrophy at a dose level of 5 mmol/kg but not at a dose level of 2.5 mmol/kg. This atrophy was not reversed within a 16-day observation period following the discontinuation of the drug.
PREGNANCY CATEGORY C
Gadopentetate dimeglumine retarded fetal development slightly when given intravenously for 10 consecutive days to pregnant rats at daily doses of 0.25, 0.75, and 1.25 mmol/kg (2.5, 7.5 and 12.5 times the human dose based on body weight) and when given intravenously for 13 consecutive days to pregnant rabbits at daily doses of 0.75 and 1.25 mmol/kg (7.5 and 12.5 tim |
