Copanlisib Pregnancy and Breastfeeding Warnings

Brand names: Aliqopa

Medically reviewed by Drugs.com. Last updated on Apr 25, 2023.

Copanlisib Pregnancy Warnings

Safety has not been established during pregnancy; based on animal studies and its mechanism of action, this drug can cause fetal harm and is expected to cause adverse fertility effects.

US FDA pregnancy category: Not Assigned

Comments:
-Following administration of radiolabeled drug to pregnant animals, approximately 1.5% of the radioactivity (parent compound and metabolites) reached the fetal compartment.
-Advise pregnant women of the potential fetal risk, and conduct pregnancy testing prior to treatment initiation.
-Counsel females of reproductive potential and males with female partners of reproductive potential to use highly effective contraception (failure rate of less than 1% per year) during treatment and for at least 1 month after the last dose.

In animal studies, this drug caused embryo-fetal death (increased resorptions, increased post-implantation loss, and decreased numbers of fetuses/dams) and fetal abnormalities (gross external, soft tissue, and skeletal) at maternally-toxic doses as low as approximately 12% of the recommended dose for humans. Additionally, there were adverse findings in male and female animal reproductive systems including effects on the testes, epididymides, prostate, ovaries, uterus, and vagina. A dose-related reduction in the number of female animals in estrus also has been observed. There are no controlled data in human pregnancy or on human fertility.

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

Copanlisib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for at least 1 month after the last dose.

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

Comments:
-The effects in the nursing infant and on milk production are unknown.
-Following administration of radiolabeled drug to lactating animals, approximately 2% of the radioactivity was secreted into milk; the milk to plasma ratio of radioactivity was 25-fold.

See references

Further information

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