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Bortezomib Pregnancy and Breastfeeding Warnings

Bortezomib is also known as: Velcade

Medically reviewed on Dec 5, 2017

Bortezomib Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: C
US FDA pregnancy category: D

This drug has caused embryo-fetal lethality in animal studies at doses lower than the clinical dose. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Bortezomib Breastfeeding Warnings

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: Unknown

See references

References for pregnancy information

  1. "Product Information. Velcade (bortezomib)." Millennium Pharmaceuticals Inc, Cambridge, MA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Velcade (bortezomib)." Millennium Pharmaceuticals Inc, Cambridge, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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