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Pregnancy: There are no or limited amount of data from the use of denosumab in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Prolia is not recommended for use in pregnant women and women of child-bearing potential not using contraception. Women should be advised not to become pregnant during and for at least 5 months after treatment with Prolia. Any effects of Prolia are likely to be greater during the second and third trimesters of pregnancy since monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.
Breast-feeding: It is unknown whether denosumab is excreted in human milk.
In genetically engineered mice in which RANKL has been turned off by gene removal (a "knockout mouse"), studies suggest absence of RANKL (the target of denosumab see Pharmacology: Pharmacodynamics under Actions) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation post-partum (see Pharmacology: Toxicology: Preclinical safety data under Actions). A decision on whether to abstain from breast-feeding or to abstain from therapy with Prolia should be made, taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Prolia therapy to the woman.
Fertility: No data are available on the effect of denosumab on human fertility. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
