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Posaconazole Pregnancy and Breastfeeding Warnings

Posaconazole is also known as: Noxafil

Medically reviewed on Jan 23, 2018

Posaconazole Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Effective contraception is recommended during therapy and for at least 2 weeks after the last dose; local protocol should be consulted regarding contraception timing.

See references

Posaconazole Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; 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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Noxafil (posaconazole)." Schering-Plough Corporation, Kenilworth, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Noxafil (posaconazole)." Schering-Plough Corporation, Kenilworth, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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