Patient Medication Information: uses, side effects, how to take - Harvoni
What is Harvoni used for?
Harvoni treats chronic (lasting longer than 6 months) hepatitis C infection in adults and children 12 years of age and older.
- Harvoni 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 Harvoni work?
Harvoni contains two medicines, ledipasvir and sofosbuvir, 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, Harvoni does not need to be taken with either interferon or ribavirin.
- Ledipasvir and sofosbuvir block the virus from making more copies of itself in the body.
- Harvoni 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 Harvoni?
Each tablet has the following medicines: ledipasvir, sofosbuvir.
Each tablet has the following ingredients that are not medicines: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, 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 FD&C Yellow #6/sunset yellow FCF aluminum lake.
Serious Warnings and Precautions
- Hepatitis B activity (eg, inflamed liver) may increase when taking antiviral drugs like Harvoni, sometimes leading to liver failure and death. (See the “To help avoid side effects…” section, Hepatitis B Reactivation)
Harvoni comes in the following dosage forms:
Harvoni comes in orange tablets. Each tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir.
Do not use Harvoni if:
- you are allergic to ledipasvir, sofosbuvir or any of the other ingredients in this product. (Read also “What are the ingredients in Harvoni?” above.)
- your doctor says you should use ribavirin with Harvoni and you are pregnant or may become pregnant (or if your partner is 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 Harvoni. Talk about any health conditions or problems you may have, including if you:
- have liver problems other than hepatitis C infection.
- have had a liver transplant.
- have HIV.
- are pregnant or plan to become pregnant (see “Pregnancy and Birth Control” below).
- are breastfeeding or plan to breastfeed. Do NOT breastfeed while taking Harvoni.
- are taking anything listed in the section “The following may interact with Harvoni”.
- if you were born with one of the rare problems of galactose intolerance (severe lactase deficiency or glucose/galactose malabsorption). Harvoni contains lactose.
Your doctor may monitor your blood test results during Harvoni 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 Harvoni 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.
Ask your doctor or pharmacist for advice before taking this medicine.
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 Harvoni will harm your unborn baby.
Harvoni 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 Harvoni and ribavirin, every month while on these medicines, and for 6 months after stopping them.
- You or your partner should not become pregnant while taking Harvoni 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 Harvoni and ribavirin and for 6 months after you have stopped taking them.
- Talk to your doctor about the kind of birth control you can use.
- If you or your partner becomes pregnant while taking Harvoni with ribavirin or within 6 months after you stop taking them, tell your doctor right away.
Products containing sofosbuvir:
Because Harvoni already contains sofosbuvir, do not take Harvoni with any other medicines containing sofosbuvir (eg, SOVALDI®, EPCLUSA®, 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 Harvoni:
- antacids (like Tums®, Rolaids® or Alka-Seltzer®) or medicines that have an ingredient to protect the stomach, used for heartburn and indigestion.
- amiodarone (Cordarone®), a drug used to treat certain irregular heartbeats (see “What are possible side effects from using Harvoni?”).
- carbamazepine (Tegretol®), a drug used to treat seizures, nerve pain and bipolar disorder.
- digoxin (Lanoxin®, Toloxin®), a drug used to treat congestive heart failure.
- tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®), 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®).
- phenobarbital, a drug used to treat anxiety and to control seizures.
- phenytoin (Dilantin®), a drug used to control seizures.
- 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.
- simeprevir* (Galexos®), a drug used to treat hepatitis C.
- 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.
*Drug not marketed in Canada.
How to take Harvoni:
Take this medicine with or without food.
- Your doctor will determine how long you need to take this medicine. It can be for 8, 12 or 24 weeks.
- If you are taking an antacid, you may need to take Harvoni at a different time than the antacid. Talk to your doctor.
- Do NOT stop taking Harvoni without first talking with your doctor.
Usual dose: Adults and children 12 years of age and older
- Take one tablet once each day.
Overdose:
| If you think you, or a person you are caring for, have taken too much Harvoni, 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 Harvoni each day.
- If you miss a dose of Harvoni 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 Harvoni 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 5 hours after taking Harvoni, take another tablet.
- If you vomit more than 5 hours after taking Harvoni, wait. Do NOT take another tablet until you are scheduled to take the next tablet.
What are possible side effects from using Harvoni?
These are not all the possible side effects you may have when taking Harvoni. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of Harvoni are: feeling tired and headache.
When Harvoni is used with amiodarone (a heart drug), side effects may be:
- slow heartbeat leading to a need for a pacemaker or death. (see the “Serious side effects and what to do about them” table below for symptoms)
| 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 | ||
| RARE | |||
Slow heartbeat (bradycardia) when taken with amiodarone (Cordarone®) with symptoms such as:
| ✓ ✓ ✓ ✓ ✓ ✓ ✓ | ||
| Serious Allergic Reactions: skin rashes with or without blisters, swelling of the face, lips, tongue or throat, trouble breathing | ✓ | ||
| 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 Harvoni below 30°C (86°F).
- Keep Harvoni in its original container.
- Do NOT use Harvoni 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 Harvoni:
- 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 June 21, 2021
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
ATRIPLA®, COMPLERA®, HARVONI®, SOVALDI®, STRIBILD®, TRUVADA®, EPCLUSA®, 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.
© 2021 Gilead Sciences, Inc. All rights reserved.
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