Patient Medication Information: uses, side effects, how to take - Vosevi
What is Vosevi used for?
Vosevi is used to treat chronic (long-lasting) hepatitis C in adults who have:
- genotype 1, 2, 3, 4, 5, or 6 infection and have been previously treated with a type of medicine called an NS5A inhibitor.
- genotype 1, 2, 3 or 4 infection and have been previously treated with sofosbuvir without another medicine called an NS5A inhibitor.
How does Vosevi work?
Vosevi contains three medicines put together into one tablet (pill).
- Vosevi blocks the hepatitis C virus from making more copies of itself in the body.
- Vosevi cures chronic hepatitis C in most patients. Cure means the virus is no longer in your blood 3 months after finishing the medicine.
What are the ingredients in Vosevi?
Medicinal ingredients: sofosbuvir, velpatasvir, voxilaprevir.
Non-medicinal ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, ferrosoferric oxide, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, microcrystalline cellulose, talc, and titanium dioxide.
Vosevi comes in the following dosage forms:
Tablets: sofosbuvir (400 mg), velpatasvir (100 mg), and voxilaprevir (100 mg).
Do not use Vosevi if:
- You are allergic to sofosbuvir (also called Sovaldi® when it is used alone), velpatasvir (also called Epclusa® when it is used with sofosbuvir), voxilaprevir, or any of the other ingredients in this product. (Read also “What are the ingredients in Vosevi?” above.)
- You are taking any of the following medicines or natural substances:
Serious Warnings and Precautions
Hepatitis B activity (eg, inflamed liver) may increase when taking antiviral drugs like Vosevi, sometimes leading to liver failure and death. (See the “To help avoid side effects…” section, Hepatitis B Reactivation)
- dabigatran etexilate (Pradaxa®), a drug used to treat blood clots.
- rifampin (Rifadin®, Rifater®, Rofact®), a drug used to treat tuberculosis.
- phenobarbital, a drug used to treat anxiety and to control seizures.
- phenytoin (Dilantin®), a drug used to control seizures.
- rosuvastatin (Crestor®), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- St. John’s wort (Hypericum perforatum), an herbal product used for anxiety or depression.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Vosevi. Talk about any health conditions or problems you may have, including if you:
- have HIV.
- have renal impairment (problems with your kidneys). Your doctor will determine if Vosevi is right for you.
- are taking heart medication such as amiodarone (eg, Cordarone®). Your doctor may monitor your heart function while taking Vosevi (see “The following may interact with Vosevi”).
- were born with the rare problem of not being able to tolerate galactose (severe lack of lactase or cannot absorb glucose or galactose). Vosevi has lactose.
Your doctor may monitor your blood test results during Vosevi treatment if you have some conditions, for example, to check:
- how well your blood can clot if you take warfarin (Coumadin®) or other similar medicines called vitamin K antagonists, to thin the blood.
- blood sugar levels if you have diabetes.
- immunosuppressant drug levels if you receive immunosuppressive therapy.
Other warnings you should know about:
Hepatitis B Reactivation:
Taking antiviral drugs such as Vosevi may increase hepatitis B activity. This can lead to liver problems such as liver failure and death. Contact your doctor if:
- you have never been tested for hepatitis B.
- you know you have a current hepatitis B infection.
- you have had a previous hepatitis B infection.
Your healthcare professional may do blood tests:
- before hepatitis C treatment.
- to see the hepatitis B levels in your blood.
- and may order hepatitis B treatment.
Liver Issues:
Talk to your doctor if you had or have liver problems other than hepatitis C infection. Your doctor may order medical tests to determine how your liver is functioning. Tell your doctor immediately if you experience symptoms of liver failure such as:
- abdominal pain or pressure, fluid in your abdomen.
- bleeding or bruising more easily than normal.
- confusion, difficulty concentrating, loss of consciousness, tiredness.
- nausea, vomiting, diarrhea.
- dark or bloody stools, dark or brown (tea coloured urine).
- yellowing of the skin and eyes.
Pregnancy:
- If you are pregnant or plan to become pregnant, talk to your doctor before you take this medicine. The effects of Vosevi during pregnancy are not known. Avoid pregnancy while taking Vosevi. Tell your doctor if you become pregnant while taking Vosevi.
Breast-feeding:
- If you are breastfeeding or plan to breastfeed, talk to your doctor about the best way to feed your baby. Do not breastfeed while taking Vosevi.
Products containing sofosbuvir:
Because Vosevi already contains sofosbuvir, do not take Vosevi with any other medicines that have sofosbuvir (eg, Sovaldi, Harvoni®, Epclusa).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Vosevi:
- amiodarone (Cordarone®), a drug used to treat irregular heartbeats.
- atazanavir (Reyataz®), a drug used to treat HIV.
- atorvastatin (Lipitor®), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- carbamazepine (Tegretol®), a drug used to treat seizures, nerve pain, and bipolar disorder.
- cyclosporine (Neoral®, Sandimmune® I.V.), a drug used to suppress the immune system.
- digoxin (Lanoxin®, Toloxin®), a drug used to treat congestive heart failure and a certain abnormal heart rhythm (atrial fibrillation).
- efavirenz (Sustiva®, Atripla®), a drug used to treat HIV.
- fluvastatin (Lescol®, Lescol® XL), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- lopinavir, a drug used to treat HIV.
- lovastatin (Advicor®*, Mevacor®*), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- medicines for indigestion, heartburn, or ulcers. Examples are nizatidine (Axid®), famotidine (Pepcid AC®, Peptic Guard®, Ulcidine®), cimetidine (Tagamet®), ranitidine (Zantac®), esomeprazole (Nexium®), lansoprazole (Prevacid®), omeprazole (Losec®), rabeprazole (Aciphex®) and pantoprazole (Pantoloc®) or antacids (like Tums®, Rolaids® or Alka-Seltzer®) that have an ingredient to protect the stomach.
- ethinyl estradiol, a drug in some oral contraceptives used to prevent pregnancy (eg, Alesse®, Apri®, Aviane®, Marvelon®, Seasonale®, Tri-Cyclen®, Yasmin®, Yaz®).
- oxcarbazepine (Trileptal®), a drug used to control seizures.
- pravastatin (Pravachol®), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- rifabutin (Mycobutin®), a drug used to treat tuberculosis.
- rifapentine, a drug used to treat tuberculosis.
- simvastatin (Zocor®), a drug used to treat high cholesterol and to help prevent heart attacks and strokes.
- tenofovir disoproxil fumarate (Atripla, Complera®, Stribild®, Truvada®, Viread®), to treat HIV.
How to take Vosevi:
Take this medicine with food.
- If you are taking an antacid, you may need to take Vosevi at a different time than the antacid. Talk to your doctor or pharmacist.
- Do NOT stop taking Vosevi without first talking with your doctor.
Usual dose:
- Take one tablet once daily for 12 weeks.
Overdose:
| If you think you, or a person you are caring for, have taken too much Vosevi, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
It is important to take Vosevi each day.
- If you miss a dose of Vosevi and you notice within 18 hours, take a tablet as soon as you can. Then take the next dose at your usual time.
- If you miss a dose of Vosevi and you notice after 18 hours, wait and take the next dose at your usual time. Do NOT take a double dose (two doses close together).
What to do if you vomit (throw up):
- If you vomit less than 4 hours after taking Vosevi, take another tablet.
- If you vomit more than 4 hours after taking Vosevi, wait. Do NOT take another tablet until you are scheduled to take the next tablet.
What are possible side effects from using Vosevi?
These are not all the possible side effects you may have when taking Vosevi. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of Vosevi are headache, feeling tired, diarrhea, feeling sick in the stomach, problem with getting to sleep, and less energy or strength.
When sofosbuvir (one of the medicines in Vosevi) is used with other hepatitis C medicines (eg, daclatasvir* [Daklinza®], simeprevir* [Galexos®], or ledipasvir) and amiodarone (a heart drug), side effects may be:
- slow heartbeat leading to a need for a pacemaker or death.
*Drug not marketed in Canada.
Contact your doctor immediately if you have symptoms of a slow heartbeat such as:
- fainting or near-fainting.
- dizziness or lightheadedness.
- not feeling well.
- feeling weak or very tired.
- shortness of breath.
- chest pains.
- confusion or memory problems.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| FREQUENCY UNKNOWN | |||
| Hepatic decompensation and hepatic failure (liver failure): abdominal pain or pressure, fluid in your abdomen, bleeding or bruising more easily than normal, confusion, difficulty concentrating, loss of consciousness, tiredness, nausea, vomiting, diarrhea, dark or bloody stools, dark or brown (tea coloured urine), yellowing of the skin and eyes | ✓ | ||
| Stevens-Johnson Syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store Vosevi below 30°C (86°F).
- Keep Vosevi in its original container.
- Do NOT use Vosevi if the seal over the bottle opening is broken or missing.
- Keep out of reach and sight of children.
If you want more information about Vosevi:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.gilead.ca), or by calling 1-800-207-4267.
Last Revised May 19, 2021
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, COMPLERA®, EPCLUSA®, HARVONI®, SOVALDI®, STRIBILD®, VOSEVI®, TRUVADA®, and VIREAD® are trademarks of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
© 2021 Gilead Sciences, Inc. All rights reserved.
e192340-GS-005