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Daclatasvir Pregnancy and Breastfeeding Warnings

Daclatasvir is also known as: Daklinza

Daclatasvir Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm using oral doses that produced systemic exposures up to 6 (rats) and 22 (rabbits) times the human exposure at the recommended human dose (RHD). Embryofetal toxicity and teratogenicity were observed at maternotoxic oral doses that produced exposures of 25 to 33 (rats) and 72 to 98 (rabbits) times the human exposure at the RHD; maternal toxicity included mortality, adverse clinical signs, body weight loss, and reduced food intake; fetal effects included malformations (e.g., of the brain, skull, eyes, ears, nose, lip, palate, limbs, ribs, head, sternebrae), embryofetal lethality, and reduced body weights. This drug has been shown to cross the placenta in rats. There are no controlled data in human pregnancy. This drug must be used with other HCV antiviral drugs. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. 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 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 ribavirin therapy. 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. 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 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.

Use of a ribavirin-containing regimen is contraindicated in pregnant women and in the male partners of women who are pregnant; daclatasvir should not be used as monotherapy. -According to some authorities: This drug should not be used during pregnancy. For regimens containing peginterferon alfa and ribavirin: -AU TGA pregnancy category: X For daclatasvir: -AU TGA pregnancy category: B3 -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: -According to some authorities: Highly effective contraception is required in women of childbearing potential during use of this drug and for 5 weeks after the last dose. -The manufacturer product information for coadministered hepatitis C virus (HCV) antiviral drugs (especially ribavirin and peginterferon alfa) should be consulted regarding use during pregnancy and use in females and males of reproductive potential. -Effective contraception is required during ribavirin therapy and for 6 months after the last dose; local protocol should be consulted regarding contraception timing.

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Daclatasvir Breastfeeding Warnings

Amounts of this drug in breast milk are most likely very low as it is highly bound to maternal plasma proteins.

LactMed: If the mother requires this drug, it is not a reason to discontinue breastfeeding; some experts recommend against breastfeeding when this drug is used with ribavirin. -According to some authorities: Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -This drug has not been studied in nursing mothers receiving treatment for hepatitis C virus infection. -Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug. -The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered. -The manufacturer product information for ribavirin and/or peginterferon alfa should be consulted (if applicable).

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Daklinza (daclatasvir)." Bristol-Myers Squibb, Princeton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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