Sovaldi

Sovaldi is a prescription medication used with other antiviral medicines to treat chronic hepatitis C virus (HCV) infection.

Sovaldi belongs to a group of drugs called nucleotide analog polymerase inhibitors. It works by preventing the hepatitis C virus from copying genetic material to make new virus.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects include tiredness, headache, and nausea.

Sovaldi is a prescription medication used with other antiviral medicines to treat:

• adult patients with genotype 1, 2, 3, or 4 chronic hepatitis C virus (HCV) infection (without cirrhosis or with compensated cirrhosis)
• children 12 years of age and older or weighing at least 35 kg with genotype 2 or 3 chronic hepatitis C virus (HCV) infection (without cirrhosis or with compensated cirrhosis in combination with ribavirin)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Gilead Sciences, Inc.

Serious side effects may occur. See "Precautions" section.

The most common side effects of Sovaldi when used in combination with ribavirin include:

• tiredness
• headache

The most common side effects of Sovaldi when used in combination with peginterferon alfa and ribavirin include:

• tiredness
• headache
• nausea
• difficulty sleeping
• low red blood cell count

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sovaldi. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how Sovaldi works.

Especially tell your healthcare provider if you take any of the following medicines:

• amiodarone (Cordarone)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• oxcarbazepine (Trileptal, Oxtellar XR)
• phenytoin (Dilantin, Phenytek)
• phenobarbital (Luminal)
• rifabutin (Mycobutin)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• rifapentine (Priftin)
• St. John's wort (Hypericum perforatum) or a product that contains St. John's Wort
• tipranavir (Aptivus)
• atorvastatin (Monitor for statin-related adverse reactions such as myopathy (issues with the muscles that can lead to muscle weakness) and rhabdomyolysis (a rare but serious side effect in which the muscle tissue breaks down)
• warfarin (International normalized ratio (INR) values may rise and fall irregularly in those taking warfarin. As a result, frequent monitoring of INR values is recommended in patients taking warfarin)

This is not a complete list of Sovaldi drug interactions. Ask your doctor or pharmacist for more information.

Sovaldi, in combination with ribavirin or peginterferon alfa and ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Sovaldi with ribavirin or in combination with peginterferon alfa and ribavirin, and for 6 months after treatment is over.

• Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with Sovaldi and ribavirin or in combination with peginterferon alfa and ribavirin. Talk to your healthcare provider about forms of birth control that may be used during this time.
• Females must have a negative pregnancy test before starting treatment with Sovaldi and ribavirin or in combination with peginterferon alfa and ribavirin, every month while being treated, and for 6 months after your treatment ends.
• If you or your female sexual partner becomes pregnant while taking or within 6 months after you stop taking Sovaldi and ribavirin, or Sovaldi in combination with peginterferon alfa and ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available at 1-800-258-4263.

You should not take Sovaldi alone. Sovaldi should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sovaldi there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sovaldi, tell your healthcare provider if you:

• have liver problems other than hepatitis C infection
• if you have a history of hepatitis B infection
• have had a liver transplant
• have severe kidney problems or you are on dialysis
• have HIV
• have any other medical condition
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. It is not known if Sovaldi passes into your breast milk. You and your healthcare provider should decide if you will take Sovaldi or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how Sovaldi works.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sovaldi falls into category X when it is taken along with ribavirin or peginterferon alfa/ribavirin. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Sovaldi with ribavirin or in combination with peginterferon alfa and ribavirin, and for 6 months after treatment is over.

• Females and males must use 2 effective forms of birth control during treatment and for the 6 months after treatment with Sovaldi and ribavirin or in combination with peginterferon alfa and ribavirin. Talk to your healthcare provider about forms of birth control that may be used during this time.
• Females must have a negative pregnancy test before starting treatment with Sovaldi and ribavirin or in combination with peginterferon alfa and ribavirin, every month while being treated, and for 6 months after your treatment ends.
• If you or your female sexual partner becomes pregnant while taking or within 6 months after you stop taking Sovaldi and ribavirin, or Sovaldi in combination with peginterferon alfa and ribavirin, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available at 1-800-258-4263.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Sovaldi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Sovaldi.

• Take Sovaldi exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
• Do not stop taking Sovaldi without first talking with your healthcare provider. If you think there is a reason to stop taking Sovaldi, talk to your healthcare provider before doing so.
• This medication comes in tablet form.
• Take Sovaldi 1 time each day with or without food.
• If you miss a dose of Sovaldi, take the missed dose as soon as you remember the same day. Do not take more than 1 tablet (400 mg) of Sovaldi in a day. Take your next dose of Sovaldi at your regular time the next day.

The recommended dose of Sovaldi is one 400 mg tablet, taken orally, once daily with or without food.

Sovaldi is always taken with other antiviral medicines.

If you take too much Sovaldi, call your healthcare provider or go to the nearest hospital emergency room right away.

• Store Sovaldi at room temperature below 86°F (30°C).
• Keep Sovaldi in its original container.
• Do not use Sovaldi if the seal over the bottle opening is broken or missing.

Keep Sovaldi and all medicines out of the reach of children.

There is a risk of hepatitis B virus (HBV) becoming an active infection in those who have a current or previous infection with HBV and is treated with a certain antiviral medication (a direct-acting antiviral) to treat hepatitis C virus. Your healthcare provider will screen and monitor for HBV in those taking a direct-acting antiviral. Tell your healthcare provider if you have a history of hepatitis B infection or other liver problems before you are treated for hepatitis C.