Mobocertinib Pregnancy and Breastfeeding Warnings

Brand names: Exkivity

Mobocertinib Pregnancy Warnings

Use is not recommended unless clearly needed.
According to some authorities: Safety has not been established during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered during pregnancy; no data are available on use of this drug in pregnant women.

Comments:
-Pregnant women should be apprised of the potential harm to the fetus; females of childbearing potential should be advised to avoid becoming pregnant during therapy.
-Pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should be advised to use highly effective non-hormonal contraception during therapy and for 1 month after the last dose; this drug may render hormonal contraceptives ineffective.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 1 week after the last dose.

Animal studies have revealed evidence of embryolethality, fetotoxicity, and maternal toxicity. Oral administration to pregnant rats during organogenesis resulted in embryolethality due to postimplantation loss (embryofetal death), decreased fetal weights, and maternal toxicity (reduced body weight gain and food consumption) at 10 mg/kg/day (about 1.7 times the human exposure based on AUC at 160 mg once daily). There are no controlled data in human pregnancy.

Based on animal studies, this drug may impair fertility in males and females of reproductive potential.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Mobocertinib 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 is a potential for 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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