Ferric derisomaltose Pregnancy and Breastfeeding Warnings

Brand names: Monoferric

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Ferric derisomaltose Pregnancy Warnings

This drug should be used only if clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Published studies of intravenous iron use during pregnancy have not reported an association with adverse developmental outcomes, however they cannot establish or exclude a drug-related risk as they were not designed to assess for major birth defect risk.
-Untreated iron deficiency anemia (IDA) during pregnancy is associated with adverse maternal outcomes (e.g. post-partum anemia), and increased preterm delivery and low birth weight risk.
-Animal studies of iron complexes showed teratogenicity and was embryocidal in non-iron depleted pregnant animals.
-Animal studies of ferric derisomaltose administered during organogenesis caused adverse developmental outcomes (including structural abnormalities and embryofetal mortality) at doses 0.09 to 0.4 times the maximum recommended human dose.
-According to some authorities, many cases of iron deficiency anemia in the first trimester can be treated with oral iron; consider confining treatment with this drug to the second or third trimester if benefits outweigh risks.
-Rare cases of fetal bradycardia have been seen with maternal hypersensitivity reactions.

Animal studies of iron complexes have shown teratogenicity and embryocidal effects in non-anemic pregnant animals at single doses above 125 mg/kg iron (highest human dose in clinical use is 20 mg/kg iron). A combined fertility and embryofetal development study (intravenous administration in female rats from 14 days before cohabitation through gestation day 17) showed increased incidence of skeletal developmental delays at doses approximately 0.1 and 0.3 times the maximum recommended human dose (MRHD). Another animal study of administration during organogenesis showed increased maternal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, macroglossia, hydrocephaly, and small brain) at approximately 0.8 times the MRHD, with fetal malformations and reduced fetal weights also seen at 0.5 times the MRHD. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Ferric derisomaltose Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-There is no information regarding this drug on the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea).

See references

Further information

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