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Ledipasvir / sofosbuvir Pregnancy and Breastfeeding Warnings

Ledipasvir / sofosbuvir is also known as: Harvoni

Ledipasvir / sofosbuvir Pregnancy Warnings

UK: Use should be avoided. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: B Comments: -Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant; if applicable, the manufacturer product information for ribavirin should be consulted. -Effective contraception is required during ribavirin therapy and for 6 months after the last dose; local protocol should be consulted regarding contraception timing.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. Ribavirin is contraindicated in pregnant women and men whose female partners are pregnant; all animal species exposed to ribavirin have shown significant teratogenic and/or embryocidal effects. Females of reproductive potential and their male partners should not receive ribavirin unless they are using effective contraception during therapy and for 6 months after therapy. 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.

See references

Ledipasvir / sofosbuvir Breastfeeding Warnings

UK: Use is not recommended. US: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for the drug; potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered. Excreted into human milk: Unknown Excreted into animal milk: Yes (ledipasvir, GS-331007 [main circulating metabolite of sofosbuvir])

See references

References for pregnancy information

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

References for breastfeeding information

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

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