Romosozumab Pregnancy and Breastfeeding Warnings

Brand names: Evenity

Medically reviewed by Drugs.com. Last updated on Dec 18, 2023.

Romosozumab Pregnancy Warnings

Not recommended

US FDA pregnancy category: Not assigned

Risk Summary: There are no data for use in pregnant women; in rats, a low incidence of skeletal malformations was observed.

Comments: This drug is not indicated for use in women of reproductive potential.

Weekly administration to pregnant rats during the period of organogenesis revealed skeletal abnormalities at exposures greater than 31 times the expected human exposure. Administration to rats prior to mating and through the end of lactation produced minimal to slight decrease in femoral bone mineral density and/or cortical circumferences in offspring at 1.4 to 54 times the expected human exposure. This drug is not indicated for use in women of reproductive potential. There are no controlled data in human pregnancy.

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

Romosozumab Breastfeeding Warnings

Not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
This drug is not indicated for use in women of reproductive potential.

See references

Further information

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