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Elotuzumab Pregnancy and Breastfeeding Warnings

Elotuzumab is also known as: Empliciti

Elotuzumab Pregnancy Warnings

Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-The effects in the developing fetus are unknown.
-This drug is administered in combination with lenalidomide and dexamethasone. Lenalidomide can cause embryofetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide and dexamethasone prescribing information for additional information.
-Male patients should use effective contraception during and for 6 months following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.

See references

Elotuzumab Breastfeeding Warnings

Not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

No information is available on the 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; however, it is administered with dexamethasone and lenalidomide, 2 drugs which also have no information on use in nursing mothers.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Empliciti (elotuzumab)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." 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. Empliciti (elotuzumab)." Bristol-Myers Squibb, Princeton, NJ.

Further information

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

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