What is 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 VOSEVI is safe and effective in children.
What is the most important information I should know about VOSEVI?
- VOSEVI can cause serious side effects, including, Hepatitis B virus reactivation: Before starting treatment with VOSEVI, 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.
VOSEVI can cause serious side effects. These serious side effects include:
- Hepatitis B virus (HBV) reactivation - 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.
- 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 of VOSEVI include:
- Headache
- Tiredness
- Diarrhea
- Nausea.
- These are not all the possible side effects of VOSEVI. Call your doctor for medical advice about side effects.
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 taking VOSEVI without first talking with your healthcare provider.
- Take 1 VOSEVI tablet by mouth each day on a regular schedule.
- Take VOSEVI with food.
- If you need to take an antacid medicine that contains aluminum or magnesium, take it either 4 hours before or 4 hours after you take your dose of VOSEVI.
- It is important that you do not miss or skip doses of VOSEVI during treatment.
- If you take too much VOSEVI, call your healthcare provider or go to the nearest hospital emergency.
Important Safety Information
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VOSEVI for a condition for which it was not prescribed. Do not give VOSEVI to other people, even if they have the same symptoms that you have. It may harm them.
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.
What should I tell my healthcare provider before taking VOSEVI?
Before taking VOSEVI, 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 if you take VOSEVI.
- 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. This can cause you to have too much or not enough VOSEVI or other medicines in your body. This may affect the way VOSEVI or your other medicines work, or may cause side effects
- You can ask your healthcare provider or pharmacist for a list of medicines that interact with VOSEVI.
General information about VOSEVI
Do not use VOSEVI for a condition for which it was not prescribed. Do not give VOSEVI to other people, even if they have the same symptoms that you have. It may harm them
What are the ingredients in VOSEVI?
Active ingredient: Sofosbuvir, Velpatasvir, and Voxilaprevir
Inactive ingredient: Colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.