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?
- Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have severe kidney problems or are on dialysis; if you have HIV; 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. If you take SOVALDI in combination with ribavirin or with peginterferon alfa and ribavirin, you should also read those Medication Guides 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
What is SOVALDI?
SOVALDI is a prescription medicine used with other antiviral medicines to treat adults with chronic (lasting a long time) hepatitis C (Hep C) with or without cirrhosis (compensated). In those with Hep C genotype (GT) 1 or 4 infection, SOVALDI is used in combination with peginterferon alfa and ribavirin. In those with GT 2 or 3 infection, SOVALDI is used in combination with ribavirin. It is not known if SOVALDI is safe and effective in adults who have had a liver transplant.
Please see Important Facts about SOVALDI including Important Warning.
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