Daclatasvir

The Basics

What is Daclatasvir?

Used with sofosbuvir and with or without ribavirin to treat chronic hepatitis C infection.

Brand names for Daclatasvir

Daklinza

How Daclatasvir is classified

Antiviral Agents, NS5A Inhibitors

Daclatasvir During Pregnancy

Daclatasvir pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Daclatasvir while pregnant

No adequate human data are available to determine whether or not DAKLINZA poses a risk to pregnancy outcomes. In animal reproduction studies in rats and rabbits, no evidence of fetal harm was observed with oral administration of daclatasvir during organogenesis at doses that produced exposures up to 6 and 22 times, respectively, the recommended human dose (RHD) of 60 mg of DAKLINZA. However, embryofetal toxicity was observed in rats and rabbits at maternally toxic doses that produced exposures of 33 and 98 times the human exposure, respectively, at the RHD of 60 mg of DAKLINZA . In rat pre-and postnatal developmental studies, no developmental toxicity was observed at maternal systemic exposure (AUC) to daclatasvir approximately 3.6 times higher than the RHD of DAKLINZA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. If DAKLINZA and sofosbuvir are administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on use in pregnancy. Data Animal Data Daclatasvir was administered orally to pregnant rats at doses of 0, 50, 200, or 1000 mg/kg/day on gestation days 6 to 15. Maternal toxicity (mortality, adverse clinical signs, body-weight losses, and reduced food consumption) was noted at doses of 200 and 1000 mg/kg/day. In the offspring, malformations of the fetal brain, skull, eyes, ears, nose, lip, palate, or limbs were observed at doses of 200 and 1000 mg/kg.

Taking Daclatasvir While Breastfeeding

What are recommendations for lactation if you're taking Daclatasvir?

Daclatasvir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If daclatasvir used alone or in combination with sofosbuvir is required by the mother, it is not a reason to discontinue breastfeeding.[1] Some sources recommend against breastfeeding when daclatasvir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[2][3] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[4][5] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[2][3]

Maternal / infant drug levels

Daclatasvir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If daclatasvir used alone or in combination with sofosbuvir is required by the mother, it is not a reason to discontinue breastfeeding.[1] Some sources recommend against breastfeeding when daclatasvir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[2][3] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[4][5] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C. Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[2][3]

Possible effects of Daclatasvir on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Daclatasvir

(Hepatitis C) Interferon Alfa, Interferon Alfacon-1, Peginterferon Alfa.