What is the most important information I should know about sofosbuvir?
If you have ever had hepatitis B, sofosbuvir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.
Sofosbuvir is used in combination with other medications, usually ribavirin with or without peginterferon alfa.
Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.
Ribavirin can cause birth defects or death in an unborn baby. Do not use sofosbuvir with ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant. Use at least 2 effective forms of non-hormonal birth control while using these medicines together and for at least 6 months after treatment ends.
What is sofosbuvir?
Sofosbuvir is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body.
Sofosbuvir is used in combination with other medications to treat hepatitis C in adults and children who are at least 12 years old or who weigh at least 77 pounds (35 kilograms).
Sofosbuvir is sometimes used in people who also have HIV, or people who have liver cancer and are going to have a liver transplant. Sofosbuvir is not a treatment for HIV or AIDS.
Sofosbuvir must be given in combination with other antiviral medications and should not be used alone. Sofosbuvir is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron).
Sofosbuvir may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking sofosbuvir?
You should not use sofosbuvir if you are allergic to it.
To make sure sofosbuvir is safe for you, tell your doctor if you have ever had:
- hepatitis B;
- liver problems other than hepatitis, or if you have had a liver transplant;
- kidney disease (or if you are on dialysis);
- HIV (human immunodeficiency virus); or
- if you have recently used a heart rhythm medicine called amiodarone (Cordarone, Pacerone).
Sofosbuvir is used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before using these medications together, and every month during your treatment.
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If you are a woman, do not use sofosbuvir with ribavirin if you are pregnant.
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If you are a man, do not use this drug combination if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
- Use at least 2 effective forms of non-hormonal birth control (condom, diaphragm with spermicide) while either sexual partner is using these medications together. Keep using 2 forms of birth control for at least 6 months after treatment ends. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using sofosbuvir with ribavirin.
It is not known whether sofosbuvir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take sofosbuvir?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sofosbuvir.
Sofosbuvir must be given in combination with other antiviral medications and it should not be used alone. Your disease may become resistant if you do not take all the medicines your doctor has prescribed.
Sofosbuvir is usually taken once per day for 12 to 24 weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take sofosbuvir with or without food. Take the medicine at the same time each day.
You will need frequent blood tests to check your liver function.
Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.
You should not stop using sofosbuvir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.
If you have ever had hepatitis B, sofosbuvir can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.
Store this medicine in the original container at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Do not take more than 400 milligrams of sofosbuvir in one day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking sofosbuvir?
Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
What are the possible side effects of sofosbuvir?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
If you take sofosbuvir and you also take a heart rhythm medicine called amiodarone: This combination of medicines can cause dangerous side effects on your heart. Get medical help right away if you take these medicines and you have:
- very slow heartbeats, chest pain, shortness of breath;
- confusion, weakness, extreme tiredness; or
- a light-headed feeling, like you might pass out.
Call your doctor at once if you have:
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low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
- headache, feeling tired;
- anemia;
- nausea; or
- sleep problems (insomnia);
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect sofosbuvir?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with sofosbuvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about sofosbuvir.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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