United States - English - NLM (National Library of Medicine)

ge healthcare - gadoterate meglumine (unii: l0nd3981ag) (gadolinium cation (3+) - unii:azv954tz9n) - clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (mri) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (bbb) and/or abnormal vascularity. history of clinically important hypersensitivity reactions to clariscan [see warnings and precautions (5.2)]. risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses of 16 and 10 times, respectively, the recommended human dose (see data) . because of the potential risks of gadolinium to the fetus, use clariscan only if imaging is essential during pregnancy and cannot be delayed. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data contrast enhancement is visualized in the placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the material indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one-month postnatal age. reproductive toxicology gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (rhd) based on body surface area (bsa)] to female rats for 14 days before mating, throughout the mating period and until gestation day (gd) 17. pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day (3, 10 and 23 times the rhd based on bsa) from gd6 to gd19. no effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day. this maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption. risk summary there are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. however, published lactation data on other gbcas indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk. additionally, there is limited gbca gastrointestinal absorption in the breastfed infant. gadoterate is present in goat milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clariscan and any potential adverse effects on the breastfed infant from clariscan or from the underlying maternal condition. data nonclinical data demonstrate that gadoterate is detected in goat milk in amounts of < 0.1% of the dose intravenously administered. furthermore, in rats, absorption of gadoterate via the gastrointestinal tract is poor (1.2% of the administered dose was absorbed and eliminated in urine). the safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dose adjustment according to age is necessary in pediatric patients [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of gadoterate meglumine has not been established in preterm neonates. no cases of nsf associated with gadoterate meglumine or any other gbca have been identified in pediatric patients age 6 years and younger [see warnings and precautions (5.1)] . normal estimated gfr (egfr) is approximately 30 ml/minute/1.73 m2 at birth and increases to adult values by 2 years of age. juvenile animal data single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. in clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. in general, use of clariscan in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. no age-related dosage adjustment is necessary. no clariscan dosage adjustment is recommended for patients with renal impairment. gadoterate can be removed from the body by hemodialysis [see warnings and precautions (5.1) and clinical pharmacology (12.3)].

Australia - English - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - gadodiamide -

United States - English - NLM (National Library of Medicine)

bayer healthcare, inc. - gadofosveset trisodium (unii: xm33q67uvh) (gadofosveset - unii:e65rw73phs) - injection - 244 mg in 1 ml - vasovist is indicated for use as a contrast agent in magnetic resonance angiography (mra) to evaluate aortoiliac occlusive disease (aiod) in adults with known or suspected peripheral vascular disease [see clinical studies (14) ]. history of a prior allergic reaction to a gadolinium-based contrast agent. pregnancy category c there are no adequate and well-controlled studies of vasovist in pregnant women. in animal studies, pregnant rabbits treated with gadofosveset trisodium at doses 3 times the human dose (based on body surface area) experienced higher rates of fetal loss and resorptions. because animal reproduction studies are not always predictive of human response, only use vasovist during pregnancy if the diagnostic benefit justifies the potential risks to the fetus. in reproductive studies, pregnant rats and rabbits received gadofosveset trisodium at various doses up to approximately 11 (rats) and 21.5 (rabbits) times the human dose (based on body surface area). the highest dose resulted in maternal t

United States - English - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - gadobutrol (unii: 1bj477io2l) (gadolinium cation (3+) - unii:azv954tz9n) - gadobutrol injection is indicated for use with magnetic resonance imaging (mri) in adult and pediatric patients, including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. gadobutrol injection is indicated for use with mri in adult patients to assess the presence and extent of malignant breast disease. gadobutrol injection is indicated for use in magnetic resonance angiography (mra) in adult and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. gadobutrol injection is indicated for use in cardiac mri (cmri) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (cad). gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection. gbcas cross the placenta and result in fetal exposure and gadolinium retention.

Canada - English - Health Canada

bracco imaging canada - gadoteridol - solution - 279.3mg - gadoteridol 279.3mg - other diagnostic agents

Canada - English - Health Canada

liebel-flarsheim canada inc - gadoversetamide - solution - 330.9mg - gadoversetamide 330.9mg - other diagnostic agents

Canada - English - Health Canada

bracco imaging canada - gadobenate dimeglumine - solution - 529mg - gadobenate dimeglumine 529mg - other diagnostic agents

Canada - English - Health Canada

bayer inc - gadofosveset trisodium - solution - 244mg - gadofosveset trisodium 244mg - other diagnostic agents

Canada - English - Health Canada

lantheus mi canada inc - gadofosveset trisodium - solution - 244mg - gadofosveset trisodium 244mg - other diagnostic agents

Canada - English - Health Canada

bayer inc - gadoxetate disodium - solution - 181.43mg - gadoxetate disodium 181.43mg - other diagnostic agents