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Denosumab Pregnancy and Breastfeeding Warnings

Denosumab is also known as: Prolia, Xgeva

Medically reviewed on Aug 1, 2017

Denosumab Pregnancy Warnings

Animal studies at doses 25-fold higher than the recommended human dose have shown increased fetal loss during gestation, stillbirths, and postnatal mortality, and absent lymph nodes. 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.

Use is contraindicated; according to some authorities, use is not recommended.

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

Risk Summary: Most experts consider this drug contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data in pregnant women to inform any drug-associated risks for adverse developmental outcomes.

Comments:
-This drug can harm a developing fetus.
-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 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. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Xgeva (denosumab)." Amgen USA, Thousand Oaks, CA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. 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 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  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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