Vosevi 400 mg/100 mg/100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vosevi 400 mg/100 mg/100 mg film-coated tablets

sofosbuvir/velpatasvir/voxilaprevir

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Vosevi is and what it is used for
2. What you need to know before taking Vosevi
3. How to take Vosevi
4. Possible adverse reactions
5. How to store Vosevi
6. Contents of the pack and other information

1. What Vosevi is and what it is used for

Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet. It is given to adults aged 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.

The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs in order to grow and reproduce, thereby eliminating the infection from the body.

2. What you need to know before taking Vosevi

Do not take Vosevi

• If you are allergic to sofosbuvir, velpatasvir, voxilaprevir, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

?If this applies to you, do not take Vosevi and inform your doctor immediately.

• If you are currently taking any of the following medicines:
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
• St. John’s wort (a herbal medicine used to treat depression);
• carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures);
• rosuvastatin (a medicine used to treat high cholesterol and reduce the risk of certain cardiovascular events);
• dabigatran (a medicine used to prevent blood clots);
• medicines containing ethinylestradiol, including many contraceptives.

Warnings and precautions

Talk to your doctor if:

• you have liver problems other than hepatitis C, for example
• you have or have had infection with the hepatitis B virus, as your doctor may want to monitor you more closely;
• you have had a liver transplant.
• you are receiving treatment for human immunodeficiency virus (HIV) infection, as your doctor may want to monitor you more closely.

Talk to your doctor or pharmacist before starting Vosevi if:

• you are currently taking or have stopped taking the medicine amiodarone for irregular heartbeat within the last few months, as this may cause a potentially life-threatening slow heart rate. Your doctor may consider alternative treatments if you have taken this medicine. If treatment with Vosevi is needed, you may require additional heart monitoring.
• you have diabetes. After starting Vosevi, you may need close monitoring of your blood glucose levels and/or adjustment of your antidiabetic medication. Some diabetic patients have experienced low blood sugar (hypoglycemia) after starting treatment with medicines like Vosevi.

Contact your doctor immediately if you are currently taking or have taken any medicine for heart problems in the past few months and, during treatment, experience:

• slow or irregular heartbeat, or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• dizziness;
• palpitations;
• fainting or near-fainting.

Blood tests

Your doctor will perform blood tests before, during, and after treatment with Vosevi. This is so that:

• Your doctor can decide whether you should take Vosevi and for how long.
• Your doctor can confirm that the treatment has worked and that you no longer have the hepatitis C virus.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. The use of Vosevi has not yet been studied in children and adolescents.

Other medicines and Vosevi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

If you are unsure, consult your doctor or pharmacist.

Some medicines should not be taken with Vosevi. If you take them together, your medicines may not work properly, or their side effects may worsen.

• Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
• St. John’s wort (a herbal medicine used to treat depression);
• Carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures);
• Rosuvastatin (a medicine used to treat high cholesterol or reduce the risk of certain cardiovascular events);
• Dabigatran (a medicine used to prevent blood clots);
• Medicines containing ethinylestradiol, including many contraceptives.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• amiodarone, used to treat irregular heartbeat;
• rifapentine (an antibiotic used to treat infections, including tuberculosis);
• oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• atazanavir, efavirenz, or lopinavir, used to treat HIV infection;
• digoxin, used to treat heart problems;
• modafinil, used to treat sleep disorders;
• atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
• cyclosporine, used to suppress the immune system.

Taking Vosevi with any of these medicines may prevent them from working properly or worsen their possible side effects. Your doctor may need to prescribe a different medicine or adjust the dose of the one you are taking.

• Ask your doctor or pharmacist if you are taking medicines used to treat stomach ulcers, heartburn, or acid reflux, as they may reduce the amount of velpatasvir in your blood. These medicines include:

• antacids (such as aluminium/magnesium hydroxide or calcium carbonate). These medicines should be taken at least 4 hours before or 4 hours after Vosevi;

• proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole). If you need high doses of these medicines, your doctor may prescribe a different medicine or adjust your dose;

• H2-receptor antagonists (such as famotidine, cimetidine, nizatidine, or ranitidine). If you need high doses of these medicines, your doctor may prescribe a different medicine or adjust your dose.

These medicines may reduce the amount of Vosevi in your blood. If you are taking any of these medicines, your doctor will either prescribe a different medicine for stomach ulcers, heartburn, or acid reflux, or advise you on how and when to take them.

• Ask your doctor or pharmacist if you are taking warfarin or similar medicines known as vitamin K antagonists, which are used to thin the blood. Your doctor may increase the number of blood tests to monitor your blood clotting.
• Your liver function may change during hepatitis C treatment, which could affect other medicines (e.g., medicines used to suppress your immune system, etc.). Your doctor may need to monitor these other medicines closely and make adjustments after starting Vosevi.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, are breastfeeding, or planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Vosevi is not recommended during pregnancy. The effects of Vosevi during pregnancy are unknown.

Breastfeeding

Do not breastfeed during treatment with Vosevi. Some of the active substances in Vosevi may pass into breast milk.

Driving and use of machines

Vosevi is not expected to affect your ability to drive or use any tools or machinery.

Vosevi contains lactose

• If you are lactose intolerant or intolerant to other sugars, you must inform your doctor. Vosevi contains lactose monohydrate. If you are lactose intolerant or have been told you are intolerant to other sugars, speak with your doctor before taking this medicine.

3. How to take Vosevi

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

The recommended dose is one tablet once a day for 8 or 12 weeks.

Swallow the tablet whole with food. Do not chew, crush, or split the tablet, as it has a very bitter taste.

Kidney problems

If you have kidney problems or are receiving dialysis, inform your doctor, as Vosevi has not been fully evaluated in patients with severe kidney problems.

Liver problems

You must not use Vosevi if you have moderate or severe liver problems.

If you are taking an antacid

Take the antacid at least 4 hours before or at least 4 hours after taking Vosevi.

If you vomit after taking Vosevi

This may affect the amount of Vosevi in your blood. This could make Vosevi less effective.

• If you vomit within 4 hours after taking Vosevi, take another tablet.
• If you vomit more than 4 hours after taking Vosevi, you do not need to take another tablet until your next scheduled dose.

If you take more Vosevi than you should

If you accidentally take more than the recommended dose of Vosevi, the risk of adverse effects from this medicine may increase (see section 4 Possible side effects).

You should contact your doctor or the nearest emergency department immediately for advice. Take the bottle of tablets with you to easily describe what you have taken.

If you forget to take Vosevi

It is important that you do not miss any doses of this medicine.

If you miss a dose, calculate how long it has been since you took your last Vosevi tablet:

• If you remember within 18 hours of your usual Vosevi dose time, take the tablet as soon as possible. Then take your next dose at the usual time.

• If 18 hours or more have passed since your usual Vosevi dose time, wait and take your next dose at the usual time. Do not take a double dose (two doses together).

Do not stop treatment with Vosevi

Do not stop treatment with this medicine unless your doctor tells you to. It is very important that you complete the full course of treatment so that the medicine is in the best possible conditions to treat hepatitis C virus infection.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects

(may affect more than 1 in 10 people)

• headache
• diarrhea
• discomfort (nausea)

Common adverse effects

(may affect up to 1 in 10 people)

• stomach pain
• decreased appetite
• vomiting
• muscle pain (myalgia)
• abnormal liver function test (total bilirubin)
• rash

Uncommon adverse effects

(may affect up to 1 in 100 people)

• muscle cramps
• swelling of the face, lips, tongue, or throat (angioedema)

Other effects that may occur during treatment with sofosbuvir:

The frequency of the following adverse effects is unknown (frequency cannot be estimated from the available data).

• severe generalized rash with skin peeling, which may be accompanied by fever, flu-like symptoms, and blisters in the mouth, eyes and/or genitals (Stevens-Johnson syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vosevi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the outer carton after “EXP”. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original container to protect it from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Vosevi

• The active substances are sofosbuvir, velpatasvir and voxilaprevir. Each film-coated tablet contains 400 mg of sofosbuvir, 100 mg of velpatasvir and 100 mg of voxilaprevir.

• The other components are

Tablet core:

Anhydrous colloidal silica, copovidone, sodium croscarmellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose.

Film coating:

Black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171).

Appearance of the product and contents of the container

The film-coated tablets are beige-colored, capsule-shaped tablets, with "GSI" engraved on one side and "3" on the other. The tablet measures 20 mm in length and 10 mm in width.

The tablets are supplied in plastic bottles with child-resistant caps. All bottles contain a desiccant with silica gel (desiccant) which must remain inside the bottle to protect the tablets. The silica gel desiccant is contained in a separate sachet or container which must not be swallowed.

The following pack sizes are available:

• Boxes containing 1 bottle of 28 film-coated tablets.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.