Virso Use In Pregnancy & Lactation

Pregnancy and concomitant use with ribavirin: When VIRSO is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin. Refer to the Summary of Product Characteristics for ribavirin for additional information.
Women of childbearing potential / contraception in males and females: When Sofosbuvir is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin. Refer to the Summary of Product Characteristics for ribavirin for additional information.
Pregnancy: There are no or limited amount of data from the use of sofosbuvir in pregnant women.
As a precautionary measure, it is preferable to avoid the use of Sofosbuvir during pregnancy. However, if ribavirin is co-administered with sofosbuvir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics for ribavirin).
Breast-feeding: It is unknown whether sofosbuvir and its metabolites are excreted in human milk. A risk to new-borns/infants cannot be excluded. Therefore, Sofosbuvir should not be used during breast-feeding.
Fertility: No human data on the effect of Sofosbuvir on fertility are available.