400 mg/100 mg/100 mg film-coated tablets, 200 mg/50 mg/50 mg film-coated tablets
sofosbuvir/velpatasvir/voxilaprevir
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 treat chronic (long-term) viral infection of the liver called hepatitis C in patients aged 12 years and older and weighing at least 30 kg.
The active substances in the medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce, which means that the infection is removed from the body.
What you need to know before using Vosevi
Do not use 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 tell 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 ( Hypericum perforatum ) (a herbal medicine used to treat mild depression)
- carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures)
- rosuvastatin (a medicine used to treat high blood cholesterol or reduce the risk of certain cardiovascular diseases)
- dabigatran etexilate (a medicine used to prevent blood clots)
- ethinylestradiol-containing medicines, including many contraceptives
Warnings and precautions
Talk to your doctor if you:
- have other liver problems besides hepatitis C, for example
- currently have or have previously had a hepatitis B virus infection, as your doctor may need to monitor you more closely
- has undergone a liver transplant
- are undergoing treatment for HIV (human immunodeficiency virus) infection, as your doctor may need to monitor you more closely.
Talk to your doctor or pharmacist before taking Vosevi if:
- you are currently taking, or have taken in recent months, the medicine amiodarone to treat irregular heartbeats, as it may cause your heart rate to drop to a life-threatening level. The doctor may consider alternative treatments if you have been taking this medicine. If you need treatment with Vosevi, extra heart monitoring may be necessary.
- you have diabetes. Your blood sugar levels may need to be monitored more closely and/or your diabetes medicines may need to be adjusted after you start taking Vosevi. In some diabetic patients, blood sugar levels have fallen (hypoglycemia) after treatment with medicines such as Vosevi has been started.
Tell the doctor immediately if you are currently taking, or have taken in the past months, any medicines for heart problems you experience during treatment:
- slow or irregular heartbeats, or heart rhythm problems
- shortness of breath or worsening of existing shortness of breath
- chest pains
- dizziness
- palpitation
- that you almost faint, or pass out
Blood samples
The doctor will check your blood before, during, and after treatment with Vosevi. This is to:
- The doctor should be able to decide if you should take Vosevi and for how long.
- The doctor must be able to confirm that the treatment has worked and that you no longer carry the hepatitis C virus.
Children and young people
Do not give this medicine to children under 12 years of age and weighing less than 30 kg. The use of Vosevi in these patients has not yet been studied.
Other medicines and Vosevi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor or pharmacist if you are unsure.
Some medicines must not be taken together with Vosevi. If you take Vosevi with any of these, the medicines may not work as well or any side effects may get worse:
- rifampicin and rifabutin ( antibiotics used to treat infections, including tuberculosis )
- St. John’s wort ( Hypericum perforatum ) (a herbal medicine used to treat mild depression)
- carbamazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures)
- rosuvastatin (a medicine used to treat high blood cholesterol or reduce the risk of certain cardiovascular diseases)
- dabigatran etexilate (a medicine used to prevent blood clots)
- ethinylestradiol-containing medicines, including many contraceptives
Tell your doctor or pharmacist if you are taking any of the medicines below:
- amiodarone used to treat irregular heartbeats
- rifapentine (an antibiotic used to treat infections, including tuberculosis )
- oxcarbazepine (a medicine used to treat epilepsy and prevent epileptic seizures)
- tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection
- atanazevir, efavirenz or lopinavir, used to treat HIV infection
- digoxin, which is used to treat heart disease
- modafinil, which is used to treat sleep disorders
- atorvastatin, pravastatin, or other statins, used to treat high cholesterol
- ciclosporin, which is used to suppress the immune system
If you take Vosevi together with any of these, the medicines may not work as well or any side effects may get worse. The doctor may need to give you another medicine or change the dose of medicine you are taking.
- Consult a 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 the blood. These are:
- antacids (eg aluminum/magnesium hydroxide or calcium carbonate ). These should be taken at least 4 hours before or 4 hours after Vosevi
- proton pump inhibitors (eg omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole). If you need high doses of these medicines, your doctor may give you another medicine or change the dose of medicine you are taking
- H 2 -receptor antagonists (eg famotidine, cimetidine, nizatidine, or ranitidine). If you need high doses of these medicines, your doctor may give you another medicine or change the dose of medicine you are taking.
These medicines can reduce the amount of Vosevi in the blood. If you are taking any of these medicines, the doctor will either give you another medicine for stomach ulcers, heartburn, or acid reflux or recommend how and when to take the medicine.
- Ask your doctor or pharmacist if you are taking warfarin or other similar medicines called vitamin K antagonists and used to thin the blood. Your doctor may need to test your blood more often to check your blood’s clotting ability.
- The function of your liver may change with the treatment of hepatitis C and therefore may affect other medicines (eg medicines used to suppress your immune system, etc.). Your doctor may need to monitor these other medicines that you are taking closely and adjustments may need to be made after treatment with Vosevi is started.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are breastfeeding, or are planning to have a baby, consult your doctor before using this medicine.
Pregnancy
Vosevi is not recommended during pregnancy. The effects of Vosevi during pregnancy are unknown.
Breast-feeding
Do not breastfeed during treatment with Vosevi. Some of the active substances in Vosevi can pass into breast milk.
Driving ability and use of machinery
Vosevi should not affect your ability to drive or use any tools or machines.
Vosevi contains lactose
Tell your doctor if you are lactose intolerant or intolerant to other sugars. Vosevi contains lactose monohydrate. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
Vosevi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Vosevi
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Recommended dose
The recommended dose of Vosevi is one 400 mg/100 mg/100 mg tablet
or two 200 mg/50 mg/50 mg tablets taken once daily for 8 or 12 weeks.
Take Vosevi as directed by your doctor.
Swallow the tablet(s) whole with food. Do not chew, crush or split the tablet as it tastes very bitter.
Kidney problems
Tell the doctor if you have kidney problems or if you are on kidney dialysis, as Vosevi has not been fully tested in patients with severe kidney problems.
Liver problems
Vosevi should not be used if you have moderate or severe liver problems.
If you take an antacid, take it at least 4 hours before or at least 4 hours after Vosevi.
If you vomit after taking Vosevi, it may affect the amount of Vosevi in your blood. This may cause Vosevi to not work as well.
- If you vomit less than 4 hours after taking Vosevi, take another dose.
- If you vomit more than 4 hours after taking Vosevi, you do not need to take another dose until you are due to take the next dose according to the treatment schedule.
If you use too much Vosevi
If you accidentally take more than the recommended dose of Vosevi, the risk of side effects from this medicine may increase (see section 4 Possible side effects ).
Contact a doctor, hospital, or Poisons Information Center immediately for advice. Take the jar of tablets with you so that you can easily describe what you have taken.
If you forget to use Vosevi
You mustn’t miss a dose of this medicine.
If you miss a dose, calculate how long it has been since you last took Vosevi:
- If you notice less than 18 hours after the time you usually take Vosevi, you must take the missed dose as soon as possible. Then take the next dose at the usual time.
- If it has been 18 hours or more after the time you usually take Vosevi, wait and take the next dose at the usual time. Do not take a double dose (two doses close to each other) to compensate for a forgotten dose.
Do not stop taking Vosevi
Do not stop taking this medicine unless your doctor tells you to. You must complete the entire course of treatment to give the medicine the best conditions for treating an infection with the hepatitis C virus.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Vosevi and see a doctor immediately if you experience any of the following symptoms:
- Swelling of the face, lips, tongue, or throat ( angioedema ) ( an uncommon side effect – may affect up to 1 in 100 people )
- Widespread, severe rash with scaly skin that may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome) ( has been reported – occurring in an unknown number of users )
Other side effects that may occur
Very common side effects are
(may affect more than 1 in 10 users)
- headache
- diarrhea
- nausea
Common side effects are
(may affect up to 1 in 10 users)
- stomach pain
- decreased appetite
- vomiting
- muscle pain ( myalgia )
- abnormal results on laboratory tests of liver function (total bilirubin )
- rash
Less common side effects are
(may affect up to 1 in 100 users)
- muscle spasms
How to store Vosevi
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the can and carton after “EXP”. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original packaging. Moisture sensitive. Close the jar well.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are sofosbuvir, velpatasvir and voxilaprevir. Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir or 200 mg sofosbuvir, 50 mg velpatasvir and 50 mg voxilaprevir.
- Other ingredients are tablet core: Colloidal anhydrous silica, copovidone, croscarmellose sodium (E468)(see section 2 of this leaflet), lactose monohydrate (see section 2 of this leaflet), magnesium stearate, microcrystalline cellulose (E460).
Film coating: Black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), macrogol (E1521), polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171).
Appearance and package sizes of the medicine
Vosevi 400 mg/100 mg/100 mg film-coated tablets are beige, capsule-shaped tablets, debossed with “GSI” on one side and “3” on the other. The tablet is 20 mm long and 10 mm wide.
Vosevi 200 mg/50 mg/50 mg film-coated tablets are beige, oval tablets, debossed with “GSI” on one side and “SVV” on the other. The tablet is 15 mm long and 8 mm wide.
The tablets are packaged in plastic jars with child-resistant lids. Each jar contains a silica gel desiccant that must be kept in the jar to protect the tablets. The silica gel desiccant is in a separate bag or container and should not be swallowed.
The following pack sizes are available for both 400 mg/100 mg/100 mg and 200 mg/50 mg/50 mg film-coated tablets:
- outer cartons containing 1 jar of 28 film-coated tablets.
Marketing Authorisation Holder
Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland
Manufacturer
Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland