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Carfilzomib Pregnancy and Breastfeeding Warnings

Carfilzomib is also known as: Kyprolis

Medically reviewed on July 28, 2017

Carfilzomib Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned

Comments:
-This drug can harm a developing fetus based on animal studies and its mechanism of action.
-Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during therapy and for at least 30 days following completion of therapy.
-Advise male patients of reproductive potential to use effective contraception to prevent pregnancy during therapy and for at least 90 days following completion of therapy.
-Apprise the patient of the potential hazard to the fetus if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug.

Animal studies have revealed evidence of embryofetal toxicity at doses that were lower than in patients receiving the recommended dose, but have failed to show teratogenicity. No effects on reproductive tissues were noted during animal toxicity studies. 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.

See references

Carfilzomib Breastfeeding Warnings

UK: Contraindicated
AU, US: 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: Data not available

Comments:
-The effects in the nursing infant are unknown.

No information is available on the use of this drug during breastfeeding. Because it is 97% bound to plasma proteins, the amount in milk is likely to be low.

See references

References for pregnancy information

  1. "Product Information. Kyprolis (carfilzomib)." Onyx Pharmaceuticals Inc, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Kyprolis (carfilzomib)." Onyx Pharmaceuticals Inc, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. 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 -]):

Further information

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

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