Selinexor Pregnancy and Breastfeeding Warnings

Brand names: Xpovio

Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.

Selinexor Pregnancy Warnings

Use should be avoided.

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

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

Comments:
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 1 week after the last dose.
-Advise males with a female partner of reproductive potential to use effective contraception during therapy and for 1 week after the last dose.
-Based on findings in animals, this drug may impair fertility in females and males of reproductive potential.

In animal reproduction studies, administration during organogenesis resulted in growth malformations (e.g., incomplete or delayed ossification, skeletal variations, reduced fetal weight, microphthalmia, fetal edema, malpositioned kidney, persistent truncus arteriosus) at exposures that were below the human recommended dose. There are no controlled data in human pregnancy.

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

Selinexor Breastfeeding Warnings

Use should be avoided.

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

Comments:
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for 1 week after.

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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