Lazertinib Pregnancy and Breastfeeding Warnings

Brand names: Lazcluze

Medically reviewed by Drugs.com. Last updated on Oct 1, 2024.

Lazertinib Pregnancy Warnings

Safety has not been established.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action and findings on animal studies, this drug can cause fetal harm if administered to a pregnant woman.

Comments:
-No data are available on the use of this product in pregnant women to inform a drug-related risk.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Advise female and male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the last dose. Refer to the amivantamab manufacturer prescribing information for the recommended duration of contraception during combination treatment with this drug.
-Advise pregnant women to the potential risk to the fetus.
-This drug may impair fertility in females and males of reproductive potential. These effects were reversible in women, but animal studies reported no reversibility in males within a 2-week recovery period.

Animal studies reported reduced embryofetal survival, reduced fetal body weight and maternal toxicity in pregnant rats that received oral doses of 7.5, 30, or 60 mg/kg/day during the period of organogenesis (4 times the human exposure at the recommended dose of 240 mg/day based on AUC). Similarly, studies in pregnant rabbits reported maternal toxicity, and an increase in skeletal fetal malformations at oral doses approximately 0.5 times the human exposure at the recommended 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

Lazertinib Breastfeeding Warnings

Breastfeeding should be avoided during use of this drug and for 3 weeks after the last dose.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-There is the potential of serious adverse reactions in breastfed children.

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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