Daclavir Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of daclatasvir in pregnant women.
Studies of daclatasvir in animals have shown embryotoxic and teratogenic effects. The potential risk for humans is unknown.
Daclavir should not be used during pregnancy or in women of childbearing potential not using contraception (see Precautions). Use of highly effective contraception should be continued for 5 weeks after completion of Daclavir therapy (see Interactions).
Since Daclavir is used in combination with other agents, the contraindications and warnings for those medicinal products are applicable.
For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Breast-feeding: It is not known whether daclatasvir is excreted in human milk. Available pharmacokinetic and toxicological data in animals have shown excretion of daclatasvir and metabolites in milk. A risk to the newborn/infant cannot be excluded. Mothers should be instructed not to breastfeed if patients are taking Daclavir.
Fertility: No human data on the effect of daclatasvir on fertility are available.
In rats, no effect on mating or fertility was seen.