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Harvoni

Generic Name: ledipasvir and sofosbuvir (le-DIP-as-vir & soe-FOS-bue-vir)
Brand Name: Harvoni

Harvoni is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients.

Harvoni is a combination of 2 hepatitis C virus (HCV) antiviral agents. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use Harvoni if:

  • you are allergic to any ingredient in Harvoni
  • you are taking another medicine that has sofosbuvir in it
  • you are taking a medicine that has cobicistat, elvitegravir, emtricitabine, and tenofovir in it
  • you are taking carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, rosuvastatin, simeprevir, St. John's wort, or tipranavir/ritonavir

Contact your doctor or health care provider right away if any of these apply to you.

Before using Harvoni:

Some medical conditions may interact with Harvoni. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems other than HCV (eg, cirrhosis)
  • if you have kidney problems or you are on dialysis
  • if you are taking tenofovir with HIV medicines
  • if you are taking amiodarone. The risk of slow heartbeat may be increased, especially if you are taking a beta blocker (eg, metoprolol), have heart problems, or have severe liver disease

Some MEDICINES MAY INTERACT with Harvoni. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Simeprevir because it may increase the risk of Harvoni's side effects
  • Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort, or tipranavir because they may decrease Harvoni's effectiveness
  • Digoxin or rosuvastatin because the risk of their side effects may be increased by Harvoni

This may not be a complete list of all interactions that may occur. Ask your health care provider if Harvoni may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Harvoni:

Use Harvoni as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Harvoni. Talk to your pharmacist if you have questions about this information.
  • Take Harvoni by mouth with or without food.
  • Do not take an antacid that has aluminum or magnesium in it within 4 hours of Harvoni.
  • If you take cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your doctor or pharmacist how to take it with Harvoni.
  • Harvoni works best if it is taken at the same time each day.
  • Continue to take Harvoni even if you feel well. Do not miss any doses.
  • If you miss a dose of Harvoni, take it as soon as you remember the same day and go back to your regular dosing schedule. Do not take more than 1 dose of Harvoni in the same day. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Harvoni.

Important safety information:

  • Tell your doctor or dentist that you take Harvoni before you receive any medical or dental care, emergency care, or surgery.
  • Harvoni does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
  • Do not change your dose or stop taking Harvoni or any of your medicines without checking with your doctor.
  • Cases of slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with Harvoni and certain other HCV medicines. Sometimes, this has been fatal. Slow heartbeat has happened up to 2 weeks after starting HCV treatment. You will need to be monitored closely if you will be taking amiodarone with HCV treatment. Follow what your doctor has told you to do. Call your doctor right away if you have symptoms of slow heartbeat (eg, chest pain, confusion, dizziness or lightheadedness, fainting or near-fainting, memory problems, shortness of breath, tiredness or weakness).
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Harvoni while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Harvoni, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Harvoni:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Harvoni:

Store Harvoni at room temperature below 86 degrees F (30 degrees C). Keep Harvoni in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Harvoni out of the reach of children and away from pets.

General information:

  • If you have any questions about Harvoni, please talk with your doctor, pharmacist, or other health care provider.
  • Harvoni is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Harvoni or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Harvoni. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Harvoni. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Harvoni.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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