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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. There are no controlled data in human pregnancy. No human data available to inform a drug-related risk. A background risk of major birth defects and miscarriage in clinically recognized pregnancies has been estimated at 2% to 4% and 15% to 20%, respectively, in the US general population. Pregnancy must be avoided in female patients and female partners of male patients using a ribavirin-containing regimen. 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. To monitor maternal-fetal outcomes of pregnant patients or pregnant partners of male patients exposed to ribavirin, a Ribavirin Pregnancy Registry has been established. Healthcare providers and patients are encouraged to report exposures occurring during or up to 6 months before pregnancy. For additional information: 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.

AU, UK: This drug should not be used during pregnancy. US: The benefits and risks of this drug should be considered when used during pregnancy. For regimens containing ribavirin or peginterferon alfa/ribavirin (AU, UK): -AU TGA pregnancy category: X For daclatasvir: -AU TGA pregnancy category: B3 -US FDA pregnancy category: Not assigned. Comments (AU, UK): -Highly effective contraception is required during use of this drug and for 5 weeks after the last dose; effective contraception (at least 2 reliable forms) is required during ribavirin therapy and for at least 6 months after the last dose; local protocol should be consulted regarding contraception timing. -The manufacturer product information for coadministered drugs (especially ribavirin and peginterferon alfa) should be consulted.

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Daclatasvir Breastfeeding Warnings

AU, UK: Breastfeeding is not recommended during use of this drug. US: 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.

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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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