Radium 223 dichloride Pregnancy and Breastfeeding Warnings

Brand names: Xofigo

Medically reviewed by Drugs.com. Last updated on Mar 7, 2025.

Radium 223 dichloride Pregnancy Warnings

Use of radium Ra 223 dichloride is contraindicated.

FDA pregnancy category: X

Comments: Because of potential effects on spermatogenesis associated with radiation, advise men who are sexually active to use condoms and their female partners of reproductive potential to use a highly effective contraceptive method during and for 6 months after completing treatment with radium Ra 223 dichloride

While there are no human or animal data on use in pregnancy and Radium Ra 223 dichloride is not indicated for use in women, maternal use of a radioactive therapeutic agent could affect development of a fetus. Radium Ra 223 dichloride is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment.

FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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Radium 223 dichloride Breastfeeding Warnings

Radium Ra 223 dichloride 223 is not indicated for use in female patients. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

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Further information

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

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