sofosbuvir

What is the most important information I should know about sofosbuvir?

If you've ever had hepatitis B, it may become active or get worse while using or after you stop using sofosbuvir. You may need frequent liver function tests for several months.

What is sofosbuvir?

Sofosbuvir is an antiviral medicine that is used to treat chronic hepatitis C in adults and children who are at least 3 years old.

Sofosbuvir treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

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 may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sofosbuvir?

Tell your doctor if you have ever had:

• hepatitis B (you may be tested for this before you take sofosbuvir);
• a liver transplant;
• liver problems other than hepatitis C;
• kidney disease (or if you are on dialysis);
• HIV or AIDS;
• a heart rhythm problem for which you take a medicine called amiodarone; or
• if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

How should I take sofosbuvir?

Sofosbuvir must be given in combination with other antiviral medications and it should not be used alone.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Do not chew sofosbuvir oral pellets. To take with food, you may mix the pellets with a non-acidic soft food (pudding, chocolate syrup, mashed potato, ice cream) that is at room temperature or below. Swallow the mixture without chewing, no more than 30 minutes after mixing. Do not save the mixture for later use.

Sofosbuvir doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You will need frequent blood tests to check your liver function.

If you've ever had hepatitis B, this virus may become active or get worse while you are using sofosbuvir or in the months after you stop. You may need liver function tests for several months after your last dose.

Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking sofosbuvir?

Avoid taking an herbal supplement containing St. John's wort.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent hepatitis C transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of sofosbuvir?

• right-sided upper stomach pain, vomiting, loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

• very slow heartbeats, chest pain, shortness of breath;
• confusion, memory problems; or
• weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common side effects may include:

• headache, feeling tired;
• anemia;
• nausea, loss of appetite; 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.

Many drugs can affect sofosbuvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. 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.