HEALTH CANADA ADVISORY
December 1, 2016
Health Canada has issued new restrictions concerning the use of Daklinza® (daclatasvir). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Galactose intolerance: Daclatasvir is prepared with lactose. If you have lactose or galactose intolerance you should not take this medication.
Liver function: This medication is intended to be taken by people with stable liver disease, including cirrhosis. The safety and effectiveness of using daclatasvir when liver function is worsening has not been determined. If you have symptoms of worsening liver function, contact your doctor as soon as possible.
Other viral infections: The safety and effectiveness of using this medication to treat hepatitis C infection when you have hepatitis B infection or human immunodeficiency virus (HIV) have not been determined. The use of daclatasvir when you have infection caused by either of these two viruses is not recommended.
Pregnancy: If you are not taking ribavirin, talk to your doctor about birth control. Effective birth control should be used while you are taking daclatasvir and for at least 5 weeks after stopping this medication.
This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if daclatasvir passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.