How does this medication work? What will it do for me?

This combination product contains 2 medications: ledipasvir and sofosbuvir. Ledipasvir and sofosbuvir both belong to a class of medications known as antivirals. Ledipasvir–sofosbuvir in combination are used to treat chronic (long-term) hepatitis C virus (HCV) infection in adults. It is also used to treat a specific genetic variation of chronic HCV infection in adolescents 12 years of age and older. Ledipasvir and sofosbuvir work in different ways to prevent the hepatitis C virus from reproducing. This quickly reduces the levels of HCV in the body.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each orange, diamond-shaped, film-coated tablet debossed with "GSI" on one side and "7985" on the other contains 90 mg of ledipasvir and 400 mg of sofosbuvir. Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and FD&C Yellow No. 6/Sunset Yellow FCF Aluminum Lake.

How should I use this medication?

The recommended dose of ledipasvir–sofosbuvir for adults and children, 12 years of age or older is one tablet, taken by mouth, once a day. It may be taken with or without food. You will need to take this medication for 12 or 24 weeks, depending on your personal health history and condition.

If you vomit less than 5 hours after taking the medication, take another dose. If it is more than 5 hours after taking the dose, continue with your regular dosing schedule.

Finish all this medication, even if you have started to feel better.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose and it is more than 18 hours before your next dose, take it as soon as possible and continue with your regular schedule. If it is less than 18 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original package at room temperature. Keep out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to ledipasvir–sofosbuvir or any ingredients of the medication
  • have any reason that you should not take ribavirin
  • are pregnant or may become pregnant
  • have a pregnant partner or a partner who may become pregnant

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • headache
  • nausea
  • tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • symptoms of very slow heart rate (e.g., dizziness, fainting, feeling unwell, shortness of breath, confusion, memory problems, chest pains, feeling weak or very tired)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Heart function: Taking sofosbuvir while taking certain medications to control heart rhythm may result in a serious decrease in the heart rate. This can cause severe heart problems, including heart attack. If you have a history of heart disease or are taking medications to control blood pressure or heart rhythm, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience the infection returning, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Other medications for hepatitis C: There are several combination medications available to treat chronic hepatitis C infection. Several of these combinations include sofosbuvir or ledipasvir. They may also include ingredients that work the same way as the ingredients in this medication, increasing the risk of severe drug interactions and side effects. With your doctor or pharmacist, review the ingredients of any medication that may be prescribed and compare it to the medications you are currently taking.

Lactose: This medication contains lactose. If you have a hereditary problem of galactose intolerance (severe lactase deficiency or glucose-galactose malabsorption), you should not take this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Ledipasvir–sofosbuvir may be used in combination with ribavirin.  Ribavirin may cause birth defects or the death of the fetus if it is used during pregnancy.

Two forms of effective birth control must be used during treatment with ledipasvir–sofosbuvir and ribavirin and for 6 months after stopping therapy. During this time, women will have monthly pregnancy tests to ensure they are not pregnant. Tell your doctor immediately if you or your partner becomes pregnant while using this medication.

Breast-feeding: It is not known if ledipasvir–sofosbuvir passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children younger than 12 years of age.

What other drugs could interact with this medication?

There may be an interaction between ledipasvir–sofosbuvir and any of the following:

  • aliskiren
  • amiodarone
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • apalutamide
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bilastine
  • bromocriptine
  • colchicine
  • dabigatran
  • diabetes medications (e.g., acarbose, canagliflozin, dulaglutide, gliclazide, insulin, metformin, sitagliptin)
  • digoxin
  • edoxaban
  • elagolix
  • everolimus
  • flecainide
  • H2 antagonists (e.g., famotidine, ranitidine)
  • hepatitis C antiviral medications (e.g., glecaprevir, voxilaprevir)
  • hydrocortisone
  • lumacaftor and ivacaftor
  • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, topotecan, vincristine)
  • modafinil 
  • nadolol
  • naloxegol
  • phenobarbital
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • ranolazine
  • rifabutin
  • rifampin
  • risperidone
  • St. John's wort
  • seizure medications (e.g., carbamazepine, oxcarbazepine, phenytoin, primidone)
  • silodosin
  • sirolimus
  • "statin" anti-cholesterol medications (e.g., atorvastatin, rosuvastatin)
  • tacrolimus
  • tenofovir
  • tipranavir
  • tyrosine kinase inhibitors (e.g., afatinib, lapatinib)
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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