IMPORTANT SAFETY INFORMATION
- Daklinza can cause serious side effects, including Hepatitis B virus reactivation. Your healthcare provider will do blood tests to check for hepatitis B virus infection before starting Daklinza. If you have ever had hepatitis B virus infection, the virus could become active again (called reactivation) during or after treatment with Daklinza. This may cause serious liver problems, including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after stopping Daklinza.
- Have ever had hepatitis B virus infection; have liver problems other than hepatitis C infection; have had a liver transplant; have heart problems; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Daklinza will harm your unborn baby or pass into your breast milk. When taking Daklinza in combination with sofosbuvir and ribavirin, tell your healthcare provider right away if you or your female sexual partner become pregnant. Males and females on this regimen should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Daklinza may affect the way other medicines work, and other medicines may affect how Daklinza works. Do not start taking a new medicine without telling your healthcare provider.
- Daklinza in combination with sofosbuvir and amiodarone may cause serious side effects, including slow heart rate (bradycardia). Get medical help right away if you take amiodarone with sofosbuvir and Daklinza and get any of the following: fainting or near-fainting, weakness, chest pain, dizziness or lightheadedness, tiredness, confusion, not feeling well, shortness of breath, memory problems.
Headache, low red blood cell count, tiredness, nausea.
These are not all the possible side effects of Daklinza; call your doctor concerning side effects.
Please see Full Prescribing Information, including "What is the most important information I should know about Daklinza?" in the Patient Information section.