Imetelstat Pregnancy and Breastfeeding Warnings

Brand names: Rytelo

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Imetelstat Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug may cause fetal harm when administered to a pregnant woman. No data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Counsel females of childbearing potential to use effective contraception during treatment and for 1 week after the last dose.
-Advise pregnant women of the potential risk to a fetus if this drug is used during pregnancy.
-This drug may (reversibly) impair female fertility.

Animal studies have revealed evidence of embryofetal mortality. Administration of this drug to pregnant animals during the period of organogenesis resulted in increased post-implantation loss at doses corresponding to 2.5 times to 9.3 times the human exposure at the recommended clinical dose. 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

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

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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