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Selumetinib Pregnancy and Breastfeeding Warnings

Brand names: Koselugo

Medically reviewed by Last updated on Apr 26, 2024.

Selumetinib Pregnancy Warnings

Use of this drug is not recommended during pregnancy.

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

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm to a pregnant person.

-Pregnant patients and women of childbearing potential, including female partners of male patients, should be apprised of the potential risk to the fetus.
-There are no data available on use of this drug in pregnant women to inform a drug-associated risk.
-It is recommended that a pregnancy test be performed on female patients of reproductive potential prior to initiating treatment.
-Both male and female patients of childbearing age should be advised to use effective contraception during therapy and for at least 1 week after completion of treatment.
-According to some authorities, this drug is not recommended in women of childbearing potential not using contraception. A reduction in the efficacy of oral contraceptives cannot be excluded; thus, women using hormonal contraceptives should consider an additional barrier method.

Studies in animals have shown reproductive toxicity including embryofetal death, structural defects, and reduced fetal weights. 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

Selumetinib Breastfeeding Warnings

Use should be avoided during breastfeeding.

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

-Lactating persons are advised not to breastfeed during treatment with this drug and for 1 week after the last dose.
-There is no data on this drug on the presence in human milk, its effects on the breastfed infant, or on milk production.
-A potential risk of adverse reactions in the breast-fed infant cannot be excluded.
-In animal studies, administration of this drug during gestation and early lactation was associated with adverse events in pups, including reduced growth rates and malformations.

See references

References for pregnancy information

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

References for breastfeeding information

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

Further information

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