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First Adult Injection in US of Dotarem® (gadoterate meglumine) Performed at Winthrop-University Hospital in New York
Date:9/5/2013

d, hyperhidrosis, urticaria
  • coma, convulsion, syncope, presyncope, parosmia, tremor
  • muscle contracture, muscle weakness
  • diarrhea, salivary hypersecretion
  • malaise, fever
  • NSF, in patients whose reports were confounded by the receipt of other GBCAs or in situations where receipt of other GBCAs could not be ruled out. No unconfounded cases of NSF have been reported with DOTAREM.
  • superficial phlebitis
  • 7    DRUG INTERACTIONS
    DOTAREM does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with DOTAREM have not been conducted.

    8    USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy
    Pregnancy Category C
    There are no adequate and well-controlled studies with DOTAREM conducted in pregnant women. Limited published human data on exposure to other GBCAs during pregnancy did not show adverse effects in exposed neonates. No effects on embryo fetal development were observed in rats or rabbits at doses up to 10 mmol/kg/day in rats or 3 mmol/kg/day in rabbits. The doses in rats and rabbits were respectively 16 and 10 times the recommended human dose based on body surface area. DOTAREM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    While it is unknown if DOTAREM crosses the human placenta, other GBCAs do cross the placenta in humans and result in fetal exposure.
    Reproductive and developmental toxicity studies were conducted with gadoterate meglumine in rats and rabbits. Gadoterate meglumine was administered intravenously in doses of 0, 2, 4 and 10 mmol/kg/day (or 3.2, 6.5 and 16.2 times the recommended human dose based on body surface area) to female rats for 14 days before mating throughout the mating period and until gestation day (GD) 17. Pregnant rabbits were intravenously admi
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