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Selinexor Pregnancy and Breastfeeding Warnings

Selinexor is also known as: Xpovio

Medically reviewed by Drugs.com. Last updated on Jul 17, 2019.

Selinexor Pregnancy Warnings

Use should be avoided.

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. In animal reproduction studies, administration of during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.
-Advise males with a female partner of reproductive potential to use effective contraception during therapy and for 1 week after.
-Based on findings in animals, this drug may impair fertility in females and males of reproductive potential.

Animal studies have revealed evidence of incomplete or delayed ossification, skeletal variations, reduced fetal weight, and malformations (e.g., microphthalmia, fetal edema, malpositioned kidney, persistent truncus arteriosus). 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

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

References for pregnancy information

  1. "Product Information. Xpovio (selinexor)." Karyopharm Therapeutics, Newton, MA.

References for breastfeeding information

  1. "Product Information. Xpovio (selinexor)." Karyopharm Therapeutics, Newton, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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