Elacestrant Pregnancy and Breastfeeding Warnings

Brand names: Orserdu

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

Elacestrant Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm when administered to a pregnant patient. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify the pregnancy status of females of reproductive potential should prior to initiating therapy.
-Advise women of childbearing potential to use effective contraception during therapy and for 1 week after last dose.
-Counsel male patients with female partners of reproductive potential to use a condom during treatment and for 1 week after last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryofetal mortality and malformations. Administration of oral doses during the period of organogenesis resulted in increased resorptions, post-implantation loss, and a reduced number of live fetuses at doses about 0.1 times the human AUC at the recommended dose. Reduced fetal weights and limb/skeletal malformations were noted at doses about 0.5 times the AUC at the recommended dose. There are no controlled data in human pregnancy.

This drug may impair fertility in females and males of reproductive potential based on findings from animal studies.

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

Elacestrant Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There are no data on the effects of this drug on milk production.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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