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Denosumab Pregnancy and Breastfeeding Warnings

Denosumab is also known as: Prolia, Xgeva

Medically reviewed by Drugs.com. Last updated on Aug 1, 2019.

Denosumab Pregnancy Warnings

In utero exposure in cynomolgus monkeys dosed monthly at 25-fold higher than the recommended human dose (based on weight) have shown increased fetal loss, stillbirths, and postnatal mortality, along with absent lymph nodes, abnormal bone growth, and decreased neonatal growth. Out to 1 month of age, measurable blood levels of this drug were observed in offspring (22% to 621% of maternal levels). 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.

Not recommended

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

Risk Summary: There are insufficient data with use in pregnant women to inform any drug-associated risks for adverse developmental outcomes. However, based on its mechanism of action and data from animal studies, this drug may cause fetal harm during or within 5 months prior to conception.

Comments:
-Pregnancy should be ruled out prior to initiating therapy.
-Pregnant women and those of reproductive potential should be advised that exposure to this drug during pregnancy or within 5 months prior to conception can result in fetal harm.
-Women of childbearing potential should be advised to use effective contraception during therapy and for at least 5 months after the last dose.

See references

Denosumab Breastfeeding Warnings

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

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: Yes

Comments:
-The effects in the nursing infant are unknown.
-Animal studies suggest this drug may interfere with maturation of the mammary gland leading to impaired lactation postpartum.

See references

References for pregnancy information

  1. "Product Information. Prolia (denosumab)." Amgen USA, Thousand Oaks, CA.
  2. "Product Information. Xgeva (denosumab)." Amgen USA, Thousand Oaks, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Xgeva (denosumab)." Amgen USA, Thousand Oaks, CA.
  5. "Product Information. Prolia (denosumab)." Amgen USA, Thousand Oaks, CA.

Further information

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

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