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Elbasvir / grazoprevir Pregnancy and Breastfeeding Warnings

Elbasvir / grazoprevir is also known as: Zepatier

Elbasvir / grazoprevir Pregnancy Warnings

Safety has not been established during pregnancy. US FDA pregnancy category: Not assigned. Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk. 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.

Animal studies have failed to reveal evidence of teratogenicity. Both components have been shown to cross the placenta in rats and rabbits. 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

Elbasvir / grazoprevir Breastfeeding Warnings

Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -If applicable, the manufacturer product information for ribavirin should be consulted.

See references

References for pregnancy information

  1. "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Company Inc, Whitehouse Station, NJ.

References for breastfeeding information

  1. "Product Information. Zepatier (elbasvir-grazoprevir)." Merck & Company Inc, Whitehouse Station, NJ.

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