Mirdametinib Pregnancy and Breastfeeding Warnings

Brand names: Gomekli

Mirdametinib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Advise females of reproductive potential to use effective contraception during treatment and for 6 weeks after the last dose.
-Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
-Based on findings in animals, this drug may impair fertility in females of reproductive potential. The reversibility of the effects on female fertility in unknown.

Animal studies in rats and rabbits have reported embryo-fetal toxicity; when administered orally to pregnant rats during organogenesis at doses of 0.3, 0.6, 3, or 5 mg/kg/day, this drug caused post-implantation loss and decreased fetal body weights at doses of 3 mg/kg/day or higher (5 times or more the human clinical dose of 2 mg/m2 twice daily). Multiple malformations, including shortening of limbs and absence or shortening of digits were observed. Additionally, a study in rabbits reported maternal toxicity (decreased body weight and moribund condition), and spontaneous abortion at doses starting at 1 mg/kg/day (3 times or more the human clinical dose). Post-implantation loss was observed at lower doses (0.3 mg/kg/day or higher (approximately equivalent to the human clinical dose). A clinical study with this drug in humans reported one pregnancy 31 days after the last dose resulting in a first trimester spontaneous abortion. 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

Mirdametinib 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 no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

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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