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`Clinical Considerations
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`Disease-associated maternal and/or embryo/fetal risk
`Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-
`partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk
`for preterm delivery and low birth weight.
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`Fetal/Neonatal adverse reactions
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`Severe adverse reactions including circulatory failure (severe hypotension, shock
`including in the context of anaphylactic reaction) may occur in pregnant women with
`parenteral iron products (such as Injectafer) which may cause fetal bradycardia,
`especially during the second and third trimester.
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`30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryonic or fetal
`findings. This daily dose in rats is approximately 40% of the human weekly dose of
`750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered
`as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18
`mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the
`human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily
`iron dose of 4.5 mg/kg (12% of the human weekly dose based on body surface area).
`Pre-implantation loss was at the highest dose. Adverse embryonic or fetal effects were
`observed in the presence of maternal toxicity.
`
`
`Data
`
`Human Data
`
`Published data fiom randomized controlled studies, prospective observational studies and
`retrospective studies on the use of ferric carboxymaltose in pregnant women have not
`reported an association with ferric carboxymaltose and adverse developmental outcomes.
`However, these studies cannot establish or exclude the absence of any drug-related risk
`during pregnancy because of methodological limitations, including that the studies were
`not primarily designed to capture safety data nor designed to assess the risk of major birth
`defects. Maternal adverse events reported in these studies are similar to those reported
`during clinical trials in adult males and non-pregnant females [see Adverse Reactions
`(6.1)].
`
`Animal Data
`
`A pre- and post-natal development study was conducted in rats at intravenous doses up to
`18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg on a
`body surface area basis). There were no adverse effects on survival of offspring, their
`behavior, sexual maturation or reproductive parameters.
`
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`A? Each mL contains 50 mg iron {as
`
`ferric Gr‘boxymaltose} in water for
`injection. Also contains hydrochloric
`acid andxhr sodium hydroxide to
`adjust pH, if necrssary. Store at EU”
`to 2 ST. {63" to FEWF]; excursions
`permitted to 15" to HEP-C {59" to
`SEPFJ. {See USP Controlled Room
`Temperature}. Sterile, nonpyrogenic
`Recommended Dose: See PrEcrihing
`Information.
`
`NBC-0511061001
`InJectafer‘i
`(ferric tarhpxymaltese injectiun)
`
`Rxflnly
`
`500 mg [10 ml.
`{50 mgme)
`Far Intravenous Use Only
`ingleD-ase 1iiial. Discard Unused Portion.
`
`flMERICfiiH REGE HI INC.
`SHIRLEY, lil'lr 1196?
`
`Lot # and
`
`expiration
`date will be
`printed here
`during
`Packaging.
`The
`
`expiration
`date will be
`expressed as
`MMNWY
`{numerical}.
`
`lnjectafer'R is manufactured under
`license from Uitor {International}, Inc.,
`Switzerland.
`RHI 1234-1.
`
`Rex. 91'2020
`
`(
`
`
`
`