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Sofosbuvir Pregnancy and Breastfeeding Warnings

Sofosbuvir is also known as: Sovaldi

Sofosbuvir Pregnancy Warnings

Animal studies with this drug have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Monotherapy is not recommended. Pregnancy must be avoided in female patients and female partners of male patients during combination therapy. Females of reproductive potential and their male partners should not receive ribavirin unless they are using at least 2 reliable forms of effective contraception during therapy and for at least 6 months after therapy. A negative pregnancy test should be obtained immediately before the start of therapy and monthly pregnancy testing is recommended during and for 6 months after therapy. AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant. Sofosbuvir should be used during pregnancy only if the benefit outweighs the risk to the fetus; as a precaution, some experts prefer to avoid use during pregnancy. For regimens containing ribavirin or peginterferon alfa: -AU TGA pregnancy category: X For sofosbuvir: -AU TGA pregnancy category: B1 -US FDA pregnancy category: B

See references

Sofosbuvir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; a decision should be made to discontinue breastfeeding or discontinue the ribavirin-containing regimen, taking into account the importance of the therapy to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes (the main circulating metabolite [GS-331007]) Comments: -The effects in the nursing infant are unknown. -The manufacturer product information for ribavirin and peginterferon alfa should be consulted.

See references

References for pregnancy information

  1. "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences, Foster City, CA.
  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. Sovaldi (sofosbuvir)." Gilead Sciences, Foster City, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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