VOSEVI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated) who have previously been treated with a Hep C regimen containing an NS5A inhibitor.
Important Safety Information
What is the most important information I should know about VOSEVI?
VOSEVI can cause serious side effects, including:
- Hepatitis B virus reactivation: Before starting VOSEVI 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 or after treatment with VOSEVI. This may cause serious liver problems including liver failure and death. If you are at risk, your healthcare provider will monitor you during treatment and after you stop taking VOSEVI.
Who should not take VOSEVI?
- Do not take VOSEVI if you take medicines that contain rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®).
What should I tell my healthcare provider before taking VOSEVI?
- Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection or liver problems other than hepatitis C infection; if you have severe kidney problems or are on dialysis; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if VOSEVI will harm your unborn baby or pass into your breast milk.
- Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VOSEVI and certain other medicines may affect each other, or may cause side effects.
What are the possible side effects of VOSEVI?
Serious side effects may also include:
- In people who had or have advanced liver problems before starting treatment with VOSEVI: rare risk of worsening liver problems, liver failure and death.
Your healthcare provider will check you for signs and symptoms of worsening liver problems during treatment with VOSEVI. Tell your healthcare provider right away if you have any of the following: nausea; tiredness; yellowing of your skin or white part of your eyes; bleeding or bruising more easily than normal; confusion; dark, black or bloody stool; loss of appetite; diarrhea; dark or brown (tea-colored) urine; swelling of your stomach area (abdomen) or pain on the upper right side of your stomach area; sleepiness; vomiting of blood; or lightheadedness.
- Slow heart rate (bradycardia): VOSEVI, when taken in combination with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases, slow heart rate has led to death or the need for a heart pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with VOSEVI 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 VOSEVI include headache, tiredness, diarrhea, and nausea.
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.
Please see Important Facts about VOSEVI including Important Warning.