Melphalan flufenamide Pregnancy and Breastfeeding Warnings

Brand names: Pepaxto

Melphalan flufenamide Pregnancy Warnings

This drug should be used during pregnancy only when clearly necessary.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal studies and its mechanism of action, the use of this drug can cause fetal harm.

Comments:
-This drug can cause fetal harm when administered to pregnant women.
-This drug can cause amenorrhea in premenopausal females and result in infertility.
-Verify the pregnancy status of females of reproductive potential before starting treatment.
-Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose.
-Advise males with a female partner of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.

There are no animal studies to evaluate the risk of exposure to the mother or the unborn child. This drug is genotoxic and has shown to be toxic to actively dividing animal cells. This drug has the potential to be teratogenic and cause embryo-fetal lethality. Based on animal toxicology studies, this drug may impair fertility in males and cause irreversible testicular suppression. 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.

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Melphalan flufenamide Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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

Comments:
-This drug should not be used during breastfeeding and for at least 1 week following the last dose.
-The effects on the nursing infant and milk production are unknown.

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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