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Generic Name: sofosbuvir, velpatasvir, and voxilaprevir
Dosage Form: Tablets
Date of Approval: July 18, 2017
Company: Gilead Sciences, Inc.

Treatment for: Hepatitis C

FDA Approves Vosevi

The U.S. Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6.

Patient Information

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Vosevi can cause serious side effects, including:
Hepatitis B virus reactivation: Before starting treatment, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with Vosevi.
Hepatitis B virus becoming active again (called reactivation) 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 you stop taking Vosevi.

For more information about side effects, see the section Vosevi side effects.

What is Vosevi?

Vosevi is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis who have:

  • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
  • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

It is not known if this medicine is safe and effective in children.

Do not take Vosevi if you also take any medicines that contain rifampin (Rifater, Rifamate, Rimactane, Rifadin).

Before taking Vosevi

Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:

  • have ever had hepatitis B infection
  • have liver problems other than hepatitis C infection
  • have severe kidney problems or you are on dialysis
  • are pregnant or plan to become pregnant. It is not known if Vosevi will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Vosevi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all of the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Vosevi and other medicines may affect each other, and can cause you to have too much or not enough Vosevi or other medicines in your body. This may affect the way your medicines work, or may cause side effects.

Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with Vosevi.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Vosevi with other medicines.

How should I take Vosevi?

  • Take Vosevi exactly as your healthcare provider tells you. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop treatment without first talking with your healthcare provider.
  • Take one tablet by mouth each day on a regular schedule.
  • Take the tablet with food.
  • If you need to take an antacid medicine that contains aluminum or magnesium, take it either four hours before or four hours after you take your dose of Vosevi.
  • It is important that you do not miss or skip doses during treatment.
  • If you take too much, or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Vosevi side effects

Vosevi may cause serious side effects, including:

  • Hepatitis B virus (HBV) reactivation. See Important information.
  • Slow heart rate (bradycardia). Vosevi treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone, Nexterone, Pacerone), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with medicines similar to Vosevi that contain 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
    • memory problems

The most common side effects include headache, tiredness, diarrhea, and nausea.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Vosevi?

  • Store Vosevi below 86°F (30°C).
  • Keep the tablets in the original container.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Vosevi

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Vosevi that is written for health professionals.

What are the ingredients in Vosevi?

Active ingredients: sofosbuvir, velpatasvir, and voxilaprevir

Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The tablet film-coat contains: ferrosoferric oxide, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

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