Patient Medication Information: uses, side effects, how to take - Epclusa
What is Epclusa used for?
Epclusa treats chronic (lasting longer than 6 months) hepatitis C infection in adults and children 12 years of age and older and weighing 30 kg and more.
- Epclusa may be used with ribavirin, but not always. Read the ribavirin patient medication information if your doctor says you should also take ribavirin.
How does Epclusa work?
Epclusa contains two medicines, sofosbuvir and velpatasvir, that have been combined together into one tablet (pill). This type of treatment course (regimen) is also known as a single tablet regimen. It provides a complete treatment for hepatitis C. For most patients, Epclusa does not need to be taken with ribavirin.
- Sofosbuvir and velpatasvir block the virus from making more copies of itself in the body.
- Epclusa cures chronic hepatitis C in most patients. Cure means hepatitis C virus is cleared from your blood 3 months after finishing the medicine.
What are the ingredients in Epclusa?
Each tablet has the following medicines: sofosbuvir, velpatasvir.
Each tablet has the following ingredients that are not medicines: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Each tablet is covered with the following ingredients that are not medicines: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.
Epclusa comes in the following dosage forms:
Epclusa comes in pink tablets. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir.
Do not use Epclusa if:
- You are allergic to velpatasvir, sofosbuvir or any of the other ingredients in this product. (Read also “What are the ingredients in Epclusa?” above.)
Serious Warnings and Precautions
- Hepatitis B activity (eg, inflamed liver) may increase when taking antiviral drugs like Epclusa, sometimes leading to liver failure and death. (See the “To help avoid side effects…” section, Hepatitis B Reactivation)
- You are taking Epclusa with ribavirin and you are pregnant or may become pregnant or if your partner(s) is (are) pregnant or may become pregnant. Ribavirin may cause birth defects or the death of your unborn baby.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Epclusa. Talk about any health conditions or problems you may have, including if you:
- have liver problems other than hepatitis C infection.
- have had a recent liver transplant.
- have HIV.
- are pregnant or plan to become pregnant (see “Pregnancy and Birth Control” below).
- are breast-feeding or plan to breastfeed. Do NOT breastfeed while taking Epclusa.
- are taking anything listed in the section “The following may interact with Epclusa”.
- Your doctor may monitor your liver function during Epclusa treatment, under some conditions.
Your doctor may monitor your blood test results during Epclusa 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 Epclusa 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 provider may do blood tests:
- before hepatitis C treatment.
- to see the hepatitis B levels in your blood.
- and may order hepatitis B treatment.
Pregnancy and Birth Control:
If you are pregnant or plan to become pregnant, ask your doctor for advice before taking this medicine. It is NOT known if Epclusa will harm your unborn baby.
Epclusa may be used with ribavirin. Ribavirin may cause birth defects and death of the unborn baby. Extreme care must be taken to avoid becoming pregnant.
- Females must have a negative pregnancy test before starting Epclusa and ribavirin, every month while on the medicine, and for 6 months after stopping them.
- You or your partner should not become pregnant while taking Epclusa with ribavirin and for 6 months after you have stopped taking them.
- You and your partner must use 2 kinds of birth control while taking Epclusa and ribavirin and for 6 months after you have stopped taking them.
- Talk to your doctor about the kind of birth control that you can use.
- If you or your partner becomes pregnant while taking Epclusa and ribavirin or within 6 months after you stop taking them, tell your doctor right away.
Products containing sofosbuvir:
Because Epclusa already contains sofosbuvir, do not take Epclusa with any other medicines containing sofosbuvir (eg, Sovaldi®, Harvoni®, Vosevi®).
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 Epclusa:
- amiodarone (Cordarone®), a drug used to treat irregular heartbeats (see “What are possible side effects from using Epclusa?”).
- 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.
- digoxin (Lanoxin®, Toloxin®), a drug used to treat congestive heart failure and a certain irregular heartbeat (atrial fibrillation).
- efavirenz (Sustiva®, Atripla®), a drug used to treat HIV.
- 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.
- oxcarbazepine (Trileptal®), a drug used to control seizures.
- phenobarbital, a drug used to treat anxiety and to control seizures.
- phenytoin (Dilantin®), a drug used to control seizures.
- rifabutin (Mycobutin®), a drug used to treat tuberculosis.
- rifampin (Rifadin®, Rifater®, Rofact®), a drug used to treat tuberculosis.
- rifapentine, a drug used to treat tuberculosis.
- 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.
- tipranavir (Aptivus®) or tipranavir/ritonavir (Aptivus® and Norvir®), drugs used to treat HIV.
- tenofovir disoproxil fumarate (Atripla, Complera®, Stribild®, Truvada®, Viread®), to treat HIV.
How to take Epclusa:
Take this medicine with or without food.
- This medicine is taken for 12 weeks.
- If you are taking an antacid, you may need to take Epclusa at a different time than the antacid. Talk to your doctor or pharmacist.
- Do NOT stop taking Epclusa without first talking with your doctor.
Usual dose:
Adults and children 12 years of age and older and weighing 30 kg and more:
- Take one tablet once each day.
Overdose:
| If you think you, or a person you are caring for, have taken too much Epclusa, 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 Epclusa each day.
- If you miss a dose of Epclusa 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 Epclusa 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 3 hours after taking Epclusa, take another tablet.
- If you vomit more than 3 hours after taking Epclusa, wait. Do NOT take another tablet until you are scheduled to take the next tablet.
What are possible side effects from using Epclusa?
These are not all the possible side effects you may have when taking Epclusa. If you experience any side effects not listed here, tell your healthcare professional.
If your side effect is not listed here, contact your doctor or pharmacist.
The most common side effects of Epclusa are: feeling tired and headache.
When sofosbuvir (one of the medicines in Epclusa) 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.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your doctor.
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 | |||
| 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 Epclusa below 30°C (86°F).
- Keep Epclusa in its original container.
- Do NOT use Epclusa if the seal over the bottle opening is broken or missing.
- Keep this medication where children cannot reach it or see it.
If you want more information about Epclusa:
- 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 August 8, 2022
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, COMPLERA®, HARVONI®, EPCLUSA®, SOVALDI®, STRIBILD®, TRUVADA®, VIREAD®, and VOSEVI® are trademarks of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
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