Denosumab Pregnancy and Breastfeeding Warnings
Denosumab Pregnancy Warnings
Animal studies have shown increased fetal loss during gestation, stillbirths, and postnatal mortality. There are no controlled data in human pregnancy. Additionally, the effects on the fetus are likely to be greater during the second and third trimesters of pregnancy. If the patient becomes pregnant during therapy, use should be discontinued and the patient should consult her physician. Women who become pregnant during treatment are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call: -(US): 1-800-77-AMGEN (1-800-772-6436) to enroll -(UK): Contact details are provided in the patient the Package Leaflet 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US 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.
-Use is not recommended and should be used during pregnancy only if the benefit outweighs the risk. -(US): Prolia(R): Use is contraindicated AU TGA pregnancy category: D US FDA pregnancy categories: -Prolia(R): X -Xgeva(R): D Comments: -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 the fetus. -Use of highly effective methods of contraception should be used during therapy and for at least 5 months after the last drug dose.
Denosumab Breastfeeding Warnings
Women who are breastfeeding during treatment are encouraged to enroll in Amgen's Lactation Surveillance Program. Patients or their physicians should call: -(US): 1-800-77-AMGEN (1-800-772-6436) to enroll -(AU): Enrolment may be arranged by telephoning Amgen's Medical Information line on 1800 803 638 (free call within Australia) -(UK): Contact details are provided in the patient the Package Leaflet -Preclinical studies in Receptor activator of nuclear factor kappa-B ligand (RANK/RANKL)-knockout mice suggest absence of RANKL (the target of denosumab) during pregnancy may interfere with maturation of the mammary gland leading to impaired lactation postpartum.
A decision should be made whether 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: Yes Comments: The effects in the nursing infant are unknown.
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