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Generic Name:

ledipasvir-sofosbuvir, Oral tablet

All Brands

  • Harvoni
SECTION 1 of 4

Highlights for ledipasvir-sofosbuvir

Oral tablet
1

Ledipasvir/sofosbuvir is a combination oral drug used to treat chronic hepatitis C virus infection.

2

The standard dose is one tablet taken per day with or without food. Each single tablet is made up of 90 mg ledipasvir and 400 mg sofosbuvir.

3

Common side effects include weakness, headache, diarrhea, nausea, and trouble sleeping.

4

You may still be able to pass the hepatitis C virus to other people when you’re taking this medication. Take safety measures to prevent spreading the virus.

5

Take this medication exactly as prescribed by your doctor.This will reduce the risk of the virus becoming resistant to treatment.

IMPORTANT INFORMATION

Amiodarone warning

If you’re taking amiodarone, a heart drug, you shouldn’t take this drug. This combination can slow down your heart rate to a low level and be fatal. Call your doctor right away if you have these symptoms:

  • fainting or feeling like you may faint
  • lightheadedness
  • a general feeling of weakness
  • tiredness
  • trouble breathing
  • chest pain
  • confusion
  • trouble with your memory

Sofosbuvir warning

This drug shouldn’t be used with other products that also contain sofosbuvir. This could increase your chance of having side effects.

Other medications risk

If you take certain prescription, over-the-counter (OTC) medications, or supplements, such as St. John’s wort, they may reduce the effectiveness of this drug. Talk to your doctor before starting any other medications while you’re on this drug.

What is ledipasvir-sofosbuvir?

This drug is a prescription drug. It ‘s available as an oral tablet.

This is a combination of two drugs in a single form. Each single tablet contains ledipasvir and sofosbuvir. It’s important to know about all the drugs in the combination because they each may have unique traits.

Why it's used

This drug is used to treat chronic hepatitis C virus infection.

How it works

Ledipasvir and sofosbuvir are antiviral medications.

More Details

How it works

Ledipasvir and sofosbuvir are antiviral medications. They work together to inhibit enzymes and prevent the hepatitis C virus from making copies of itself. This stops the virus from spreading and may cure your infection.

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SECTION 2 of 4

ledipasvir-sofosbuvir Side Effects

Oral tablet

Most Common Side Effects

The most common side effects that occur with ledipasvir/sofosbuvir include:

  • a general feeling of weakness

  • headache

  • diarrhea

  • nausea

  • trouble sleeping

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1

  • severe slowing of your heart rate. If you take amiodarone for your heart, ledipasvir/sofosbuvir can slow down your heart rate to a very low level and be fatal. Symptoms may include:
    • fainting or feeling like you may faint
    • lightheadedness
    • a general feeling of weakness
    • tiredness
    • trouble breathing
    • chest pain
    • confusion
    • trouble with your memory
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

Mild side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

ledipasvir-sofosbuvir May Interact with Other Medications

Oral tablet

Ledipasvir/sofosbuvir can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Stomach acid reducing drugs

Examples are:

  • antacids
  • famotidine
  • cimetidine
  • omeprazole

These drugs can make ledipasvir/sofosbuvir less effective.

Your doctor may recommend that you take ledipasvir/sofosbuvir and these drugs at different times of the day.

Heart medications
  • amiodarone. You shouldn’t take this drug with ledipasvir/sofosbuvir. The combination can slow down your heart rate to dangerously low levels. This can be fatal.
  • digoxin. Ledipasvir/sofosbuvir can increase levels of digoxin in your body. This may cause serious side effects. Your doctor will monitor how much digoxin is in your body if you take these drugs together.

Anti-seizure medications

Examples are:

  • phenytoin
  • carbamazepine
  • phenobarbital
  • oxcarbazepine

These drugs can make ledipasvir/sofosbuvir less effective. Don’t combine ledipasvir/sofosbuvir with any of these drugs.

Tuberculosis drugs

Examples are:

  • rifabutin
  • rifampin
  • rifapentine

These drugs can make ledipasvir/sofosbuvir less effective. They shouldn’t be taken together.

Human immunodeficiency virus (HIV) medications

Examples are:

  • tenofovir or combination drugs that contain tenofovir

Ledipasvir/sofosbuvir can affect the levels of some HIV drugs. This may increase the side effects of those medications.

Hepatitis C virus drug
  • simeprevir

You shouldn’t take this drug with ledipasvir/sofosbuvir. It can increase the level of ledipasvir in your body.

Herbal supplement
  • St. John’s wort

Don’t take this supplement while taking ledipasvir/sofosbuvir. It can decrease the effectiveness of ledipasvir/sofosbuvir.

Cholesterol drug
  • rosuvastatin

Ledipasvir/sofosbuvir can increase the level of rosuvastatin in your body. This can lead to severe side effects.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Drug warnings
People with heart  problems
People with heart conditions who take amiodarone

If you’re taking the drug amiodarone for your heart, don’t take this drug. This combination can slow down your heart rate to a low level and be fatal. Call your doctor right away if you have these symptoms:

  • fainting or feeling like you may faint
  • lightheadedness
  • a general feeling of weakness
  • tiredness
  • trouble breathing
  • chest pain
  • confusion
  • trouble with your memory
Pregnant women
Pregnant women

This drug is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant animals have not shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show the drug poses a risk to the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

breastfeeding
Women who are breast-feeding

It isn’t known if this drug passes through breast milk or whether it may cause side effects in a breastfeeding child.

You and your doctor may need to decide if you’ll take this drug or breastfeed.

Children
For children

The safety and effectiveness of this drug haven’t been established in people under the age of 18 years.

Keep this drug and all medicines out of the reach of children.

When to call the doctor
When to call the doctor
  • If your symptoms don’t get better or if they get worse, talk to your doctor.
  • Talk to your doctor before starting any new drug, including prescription drugs, OTC products, vitamins, supplements, or other natural products while you’re taking this drug.
Allergies
Allergies

This drug can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

SECTION 4 of 4

How to Take ledipasvir-sofosbuvir (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Chronic hepatitis C virus infection
Form: Oral tablet
Strength: 90 mg ledipasvir and 400 mg sofosbuvir
Adult Dosage (ages 18 years and older)
  • The recommended dose is one tablet taken once per day with or without food.
  • Length of therapy:
    • If you’ve never had any treatment for hepatitis C virus infection (with or without cirrhosis), treatment is recommended for 12 weeks.
    • If you’ve been treated for hepatitis C virus infection before and you don’t have liver cirrhosis, treatment is recommended for 12 weeks.
    • If you’ve been treated for hepatitis C virus infection before and you have liver cirrhosis, treatment is recommended for 24 weeks.
Child Dosage (ages 0–17 years)

A safe and effective dose hasn’t been established in people younger than 18 years old.

Special Considerations

Kidney problems: If your kidney problems are mild or moderate, there’s no need to adjust your dose of ledipasvir/sofosbuvir. It isn’t known if ledipasvir/sofosbuvir is safe or beneficial in treating hepatitis C virus infection if you have severe kidney problems.

Liver problems: If your liver problems are mild, moderate, or severe, there is no need to adjust your dose of ledipasvir/sofosbuvir. It isn’t known if ledipasvir/sofosbuvir is safe or beneficial in treating hepatitis C virus infection if you have late stage liver disease (decompensated cirrhosis).

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug comes with serious risks if you don't take it as prescribed.

If you don't take it at all

If you don’t take this medication, the infection will continue to progress and cause more damage to your liver. This infection may be fatal if it’s not treated properly.

If you stop taking it suddenly or don't take it on schedule

The drug won’t work to treat your hepatitis infection. The infection will continue to progress and may be fatal.

If you take too much

If you think you’ve taken too much of this drug, call your doctor or go to the nearest emergency room right away.

What to do if you miss a dose

If you miss a dose, take it as soon as you can on the same day. Don’t take more than one dose per day. Take your next dose at your regular time the next day.

How to tell if the drug is working

Your doctor will tell you if the medication is working for you. They will do blood tests to check the amount of virus in your body. These blood tests may be done before, during, and after treatment.

This drug is a short-term drug treatment.

Important considerations for taking this drug
with food
You can take this drug with or without food
timing
Take this drug at the right times for best effects
 Don't crush
Don’t cut or crush this medication
storage
Store this drug at room temperature. Keep it below 86°F (30°C)
See Details
Refillable
Prescription is refillable
Travel
Travel
See Details
Clinical Monitoring
Clinical monitoring
See Details
Not Usually Stocked
Not every pharmacy stocks this drug, so call ahead
Prior authorization
Insurance
See Details

Store this drug at room temperature. Keep it below 86°F (30°C)

Store the drug in its original container, and keep it away from direct light.

Note: Keep your medications away from areas where they could get wet, such as bathrooms. Store them away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to clearly identify the medication. Keep the original prescription label box with you when traveling.
  • Don’t leave this medication in the car, especially when the temperature is hot or freezing.

Clinical monitoring

Your doctor may check the following during your treatment with this drug:

  • heart. If you’re taking the drug amiodarone for your heart while on this drug, your doctor may monitor you for signs of slowing of heart rate for at least the first two weeks of starting this drug.
  • blood test. Your doctor will do blood tests to check how well your liver is working and to check the amount of the virus in your body. The blood tests may be done before, during, and after treatment.
  • liver and kidney function

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for this drug.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on June 6, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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