Sofosbuvir

Generic Name: sofosbuvir (soe-FOS-bue-vir)
Brand Name: Sovaldi

Sofosbuvir is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used with ribavirin or in combination with peginterferon alfa and ribavirin.

Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog polymerase inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use sofosbuvir if:

  • you are allergic to any ingredient in sofosbuvir
  • you are pregnant or may become pregnant
  • your sexual partner is pregnant
  • you are taking carbamazepine, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, rifamycins (eg, rifampin), St. John's wort, or tipranavir

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

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Before using sofosbuvir:

Some medical conditions may interact with sofosbuvir. 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 able to become pregnant
  • 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), HIV infection, or anemia
  • if you have kidney problems or you are on dialysis
  • if you have had a liver transplant

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

  • Carbamazepine, hydantoins (eg, phenytoin), oxcarbazepine, phenobarbital, rifamycins (eg, rifampin), St. John's wort, or tipranavir because they may decrease sofosbuvir's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if sofosbuvir 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 sofosbuvir:

Use sofosbuvir 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 sofosbuvir. Talk to your pharmacist if you have questions about this information.
  • Sofosbuvir must be taken with either ribavirin or peginterferon alfa and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.
  • Take sofosbuvir by mouth with or without food.
  • Sofosbuvir works best if it is taken at the same time each day.
  • Continue to take sofosbuvir even if you feel well. Do not miss any doses.
  • If you miss a dose of sofosbuvir, 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 sofosbuvir 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 sofosbuvir.

Important safety information:

  • Sofosbuvir may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Sofosbuvir 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 sofosbuvir or any of your medicines without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking sofosbuvir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Women who may become pregnant and men who use sofosbuvir must use 2 effective nonhormonal forms of birth control while they take sofosbuvir with ribavirin and for at least 6 months after treatment is stopped. Talk with your doctor if you have questions about effective birth control. If you or your sexual partner become pregnant while taking sofosbuvir or within 6 months after you stop taking it, contact your doctor immediately.
  • Women of childbearing potential who either take sofosbuvir with ribavirin or are sexual partners of men who take sofosbuvir with ribavirin must have a pregnancy test before treatment is started, monthly during treatment, and monthly for 6 months after treatment is stopped.
  • Tell your doctor or dentist that you take sofosbuvir before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts and HCV levels, may be performed while you use sofosbuvir and for several months after you stop sofosbuvir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sofosbuvir should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Sofosbuvir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using sofosbuvir. If you become pregnant while taking sofosbuvir or within 6 months after you stop taking it, contact your doctor immediately. You will need to discuss the benefits and risks of using sofosbuvir while you are pregnant. It is not known if sofosbuvir is found in breast milk. Do not breast-feed while taking sofosbuvir.

Possible side effects of sofosbuvir:

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; nausea; tiredness; trouble sleeping.

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); fainting; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); pale skin; shortness of breath; suicidal thoughts or actions; unusual tiredness or weakness.

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 sofosbuvir:

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

General information:

  • If you have any questions about sofosbuvir, please talk with your doctor, pharmacist, or other health care provider.
  • Sofosbuvir 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 sofosbuvir 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 sofosbuvir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sofosbuvir. 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 sofosbuvir.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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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