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Selumetinib Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Apr 26, 2022.

Selumetinib is also known as: Koselugo

Selumetinib Pregnancy Warnings

Use should be avoided.

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 to a pregnant woman. In animal reproduction studies, administration to mice during organogenesis caused reduced fetal weight, adverse structural defects, and effects on embryofetal survival at exposures approximately 5 times the equivalent human exposure.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Negative pregnancy status should be verified 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.
-Female partners of reproductive potential should be advised to use effective contraception during therapy and for 1 week after.
-Male patients with female partners of reproductive potential should be advised to use effective contraception during therapy and for 1 week after.

Animal studies have revealed evidence of fetal harm; reduced fetal weight, adverse structural defects, and effects on embryofetal survival have been seen at exposures approximately 5 times the equivalent human exposure. 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

Selumetinib Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-This drug can harm a nursing infant.
-Advise women not to breastfeed during therapy and for 1 week after.

Administration of this drug in animal studies during gestation and early lactation was associated with adverse events in pups, including reduced growth rates and of malformations.

See references

References for pregnancy information

  1. "Product Information. Koselugo (selumetinib)." Astra-Zeneca Pharmaceuticals (2020):

References for breastfeeding information

  1. "Product Information. Koselugo (selumetinib)." Astra-Zeneca Pharmaceuticals (2020):

Further information

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