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Ledipasvir and Sofosbuvir: Uses, Side Effects and Dosage

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Prescription (Rx) Boxed warning
Strength:
90 mg, 400 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Ledipasvir and Sofosbuvir

What is the most important information I should know about ledipasvir and sofosbuvir?

Ledipasvir and sofosbuvir can cause serious side effects, including,

Hepatitis B virus reactivation: Before starting treatment with ledipasvir and sofosbuvir, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with ledipasvir and sofosbuvir. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking ledipasvir and sofosbuvir.

For more information about side effects, see the section "What are the possible side effects of ledipasvir and sofosbuvir?"

What is ledipasvir and sofosbuvir?

Ledipasvir and sofosbuvir is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV):

  • genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
  • genotype 1 infection with advanced cirrhosis (decompensated) in combination with ribavirin
  • genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis who have had a liver transplant, in combination with ribavirin

It is not known if ledipasvir and sofosbuvir is safe and effective in children with HCV under 3 years of age.

Before taking ledipasvir and sofosbuvir, tell your healthcare provider about all of your medical conditions, including if you:

  • have ever had hepatitis B virus infection
  • have liver problems other than hepatitis C infection
  • have had a liver transplant
  • have kidney problems or you are on dialysis
  • have HIV infection

  • are pregnant or plan to become pregnant. It is not known if ledipasvir and sofosbuvir tablets will harm your unborn baby.

    • Males and females who take ledipasvir and sofosbuvir in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.

  • are breastfeeding or plan to breastfeed. It is not known if ledipasvir and sofosbuvir pass into your breast milk.

    • Talk to your healthcare provider about the best way to feed your baby during treatment with ledipasvir and sofosbuvir.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ledipasvir and sofosbuvir and other medicines may affect each other. This can cause you to have too much or not enough ledipasvir and sofosbuvir or other medicines in your body. This may affect the way ledipasvir and sofosbuvir or your other medicines work, or may cause side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with ledipasvir and sofosbuvir.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ledipasvir and sofosbuvir with other medicines.

How should I take ledipasvir and sofosbuvir?

  • Take ledipasvir and sofosbuvir exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop taking ledipasvir and sofosbuvir without first talking with your healthcare provider.

  • Take ledipasvir and sofosbuvir by mouth, with or without food.

  • It is important that you do not miss or skip doses of ledipasvir and sofosbuvir during treatment.
  • For adults the usual dose of ledipasvir and sofosbuvir is one 90 mg/400 mg tablet each day.

  • For children 3 years of age and older your healthcare provider will prescribe the right dose of ledipasvir and sofosbuvir based on your child's body weight.

    • Tell your healthcare provider if your child has problems with swallowing tablets.
    • If your healthcare provider prescribes ledipasvir and sofosbuvir (HARVONI) oral pellets for your child, see "How should I give ledipasvir and sofosbuvir (HARVONI) oral pellets to my child."
  • Do not miss a dose of ledipasvir and sofosbuvir. Missing a dose lowers the amount of medicine in your blood. Refill your ledipasvir and sofosbuvir prescription before you run out of medicine.

If you take too much ledipasvir and sofosbuvir, call your healthcare provider or go to the nearest hospital emergency room right away.

How should I give ledipasvir and sofosbuvir (HARVONI) oral pellets to my child?

See the detailed Instructions for Use for information about how to give or take a dose of ledipasvir and sofosbuvir (HARVONI) oral pellets.

  • Administer ledipasvir and sofosbuvir (HARVONI) oral pellets exactly as instructed by your healthcare provider.
  • Do not open the packet until ready to use.
  • Hold the ledipasvir and sofosbuvir (HARVONI) oral pellets packet with the cut line on top.
  • Shake the ledipasvir and sofosbuvir (HARVONI) oral pellets packet gently to settle the pellets.
  • Tear or cut the ledipasvir and sofosbuvir (HARVONI) oral pellets packet along the cut line.
  • Ledipasvir and sofosbuvir (HARVONI) oral pellets can be taken right in the mouth without chewing, or with food.
  • If ledipasvir and sofosbuvir (HARVONI) oral pellets are taken with food, sprinkle the pellets on one or more spoonfuls of non-acidic soft food at or below room temperature. Examples of non-acidic foods include pudding, chocolate syrup, mashed potato, and ice cream. Take ledipasvir and sofosbuvir (HARVONI) oral pellets within 30 minutes of gently mixing with food and swallow the entire contents without chewing to avoid a bitter taste.
  • Do not store any leftover ledipasvir and sofosbuvir (HARVONI) mixture (oral pellets mixed with food) for use at a later time. Throw away any unused portion.

What are the possible side effects of ledipasvir and sofosbuvir?

Ledipasvir and sofosbuvir can cause serious side effects, including:

  • Hepatitis B virus reactivation. See "What is the most important information I should know about ledipasvir and sofosbuvir?"
  • Slow heart rate (bradycardia). Ledipasvir and sofosbuvir treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with ledipasvir and sofosbuvir tablets. Get medical help right away if you take amiodarone with ledipasvir and sofosbuvir tablets and get any of the following symptoms:
  • fainting or near-fainting
  • dizziness or lightheadedness
  • not feeling well
  • weakness
  • extreme tiredness
  • shortness of breath
  • chest pains
  • confusion
  • memory problems

The most common side effects of ledipasvir and sofosbuvir include:

  • tiredness
  • headache
  • weakness

These are not all the possible side effects of ledipasvir and sofosbuvir. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ledipasvir and sofosbuvir tablets?

  • Store ledipasvir and sofosbuvir tablets at room temperature below 86°F (30°C).

Keep ledipasvir and sofosbuvir tablets and all medicines out of the reach of children.

General information about the safe and effective use of ledipasvir and sofosbuvir

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ledipasvir and sofosbuvir for a condition for which it was not prescribed. Do not give ledipasvir and sofosbuvir to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about ledipasvir and sofosbuvir that is written for health professionals.

What are the ingredients in ledipasvir and sofosbuvir tablets (90 mg/400 mg)?

Active ingredients: ledipasvir and sofosbuvir

Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

The tablet film-coat contains: FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured for:

Asegua Therapeutics LLC, an affiliate of Gilead Sciences, Inc., Foster City, CA 94404

For more information, call 1-800-445-3235 or go to www.asegua.com.

Asegua is a trademark of Asegua Therapeutics LLC. All other trademarks referenced herein are the property of their respective owners.

205834-AG-012

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 205834 · View the label on DailyMed

Revision date stated in the text: March 2020

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ledipasvir and Sofosbuvir

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Hepatitis C Virus NS5A Inhibitor, Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Active ingredients Ledipasvir 90 mg, Sofosbuvir 400 mg
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) GILEAD SCIENCES INC
FDA approval NDA AUTHORIZED GENERIC 205834NDA authorized generic Approved October 10, 2014
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
90 mg, 400 mg – 14 in 1 blister pack / 2 in 1 carton NDC 72626-2601-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.