SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C genotype 1, 2, 3, or 4 infection in adults. It is not known if SOVALDI is safe and effective in children under 18 years of age.
Important Safety Information
What is the most important information I should know about SOVALDI?
SOVALDI can cause serious side effects, including:
- Hepatitis B virus reactivation: Before starting SOVALDI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with SOVALDI. This may cause serious liver problems including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking SOVALDI.
What should I tell my healthcare provider before taking SOVALDI?
- If you have: ever had hepatitis B infection, liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if SOVALDI will harm your unborn baby or pass into your breast milk. Patients who take SOVALDI in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy-related information.
- Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOVALDI and certain other medicines may affect each other, or may cause side effects.
What are the possible side effects of SOVALDI?
Serious side effects may also include:
- Slow heart rate (bradycardia): SOVALDI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with SOVALDI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.
The most common side effects of SOVALDI used in combination with ribavirin include tiredness and headache and when used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.
Please see Important Facts about SOVALDI including Important Warning.