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Carfilzomib Pregnancy and Breastfeeding Warnings

Carfilzomib is also known as: Kyprolis

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. 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 US: Benefit should outweigh risk. 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

References for breastfeeding information

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

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