Generic Name: sofosbuvir (soe-FOS-bue-vir)
Brand Name: Sovaldi
Sovaldi 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.
Sovaldi is an 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 Sovaldi if:
- you are allergic to any ingredient in Sovaldi
- 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.
Before using Sovaldi:
Some medical conditions may interact with Sovaldi. 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
- 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 Sovaldi. 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 Sovaldi's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sovaldi 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 Sovaldi:
Use Sovaldi 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 Sovaldi. Talk to your pharmacist if you have questions about this information.
- Sovaldi 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 Sovaldi by mouth with or without food.
- Sovaldi works best if it is taken at the same time each day.
- Continue to take Sovaldi even if you feel well. Do not miss any doses.
- If you miss a dose of Sovaldi, 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 Sovaldi 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 Sovaldi.
Important safety information:
- Tell your doctor or dentist that you take Sovaldi before you receive any medical or dental care, emergency care, or surgery.
- Sovaldi 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.
- Sovaldi 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 Sovaldi 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 Sovaldi, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Cases of slow heartbeat and the need to get a pacemaker have happened when amiodarone was given with Sovaldi 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).
- Women who may become pregnant and men who use Sovaldi must use 2 effective nonhormonal forms of birth control while they take Sovaldi 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 Sovaldi or within 6 months after you stop taking it, contact your doctor immediately.
- Women of childbearing potential who either take Sovaldi with ribavirin or are sexual partners of men who take Sovaldi with ribavirin must have a pregnancy test before treatment is started, monthly during treatment, and monthly for 6 months after treatment is stopped.
- Lab tests may be performed while you use Sovaldi and for several months after you stop Sovaldi. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: Sovaldi 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 Sovaldi. If you become pregnant while taking Sovaldi or within 6 months after you stop taking it, contact your doctor immediately. You will need to discuss the benefits and risks of using Sovaldi while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Sovaldi.
Possible side effects of Sovaldi:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; nausea; tiredness; trouble sleeping.
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 Sovaldi:
Store Sovaldi at room temperature below 86 degrees F (30 degrees C). Keep Sovaldi in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sovaldi out of the reach of children and away from pets.
- If you have any questions about Sovaldi, please talk with your doctor, pharmacist, or other health care provider.
- Sovaldi 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 Sovaldi 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 Sovaldi. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sovaldi. 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 Sovaldi.
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.