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Denosumab Pregnancy and Breastfeeding Warnings

Denosumab is also known as: Prolia, Xgeva

Denosumab Pregnancy Warnings

Counsel patients on pregnancy planning and prevention. Advise females of reproductive potential to use highly effective contraception during therapy, and for at least 5 months after the last dose of denosumab (Xgeva). Advise patients to contact their healthcare provider if they become pregnant, or a pregnancy is suspected, during treatment or within 5 months after the last dose of denosumab (Xgeva). Women who become pregnant during denosumab (Prolia) treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

Denosumab has been assigned to pregnancy category D under the trade name Xgeva (R) and pregnancy category X under the trade name Prolia (R) by the FDA. Animal studies indicate denosumab may cause fetal harm including increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth, and decreased neonatal growth. There are no controlled data in human pregnancy. Denosumab is contraindicated in women who are pregnant. 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 hazard to a fetus. There are no controlled data in human pregnancy. Denosumab is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. Denosumab is approved only for use in postmenopausal women.

Denosumab Breastfeeding Warnings

There are no data on the excretion of denosumab into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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