"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is updating labeling information for the hepatitis C antivirals ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and sofosbuvir (Sovaldi, Gilead Sciences) after th"...
Read this Patient Information before you start taking SOVALDI and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
SOVALDI is used in combination with other antiviral medicines. When taking SOVALDI with ribavirin or in combination with peginterferon alfa and ribavirin you should also read those Medication Guides.
The information in this Patient Information Leaflet talks about SOVALDI when it is used with ribavirin and in combination with peginterferon alfa and ribavirin.
What is the most important information I should know about SOVALDI?
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.
What is SOVALDI?
- SOVALDI is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults.
- SOVALDI should not be taken alone.
It is not known if SOVALDI is safe and effective in children under 18 years of age.
Who should not take SOVALDI?
See “What is the most important information I should know about SOVALDI?”
What should I tell my healthcare provider before taking SOVALDI?
Before taking SOVALDI, tell your healthcare provider if you:
- have liver problems other than hepatitis C infection
- have had a liver transplant
- have severe kidney problems or you are on dialysis
- have HIV
- have any other medical condition
- 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.
Especially tell your healthcare provider if you take any of the following medicines:
- amiodarone (Cordarone®, Nexterone®, Pacerone®)
- carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • oxcarbazepine (Trileptal®, Oxtellar XRTM)
- 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®)
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take SOVALDI?
- Take 1 tablet of SOVALDI 1 time each day only, with or without food.
- 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.
- 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.
- If you take too much SOVALDI, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of SOVALDI?
See “What is the most important information I should know about SOVALDI?”
The most common side effects of SOVALDI when used in combination with ribavirin include:
The most common side effects of SOVALDI when used in combination with peginterferon alfa and ribavirin include:
- 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.
How should I store SOVALDI?
- 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.
General information about the safe and effective use of SOVALDI
It is not known if treatment with SOVALDI will prevent you from infecting another person with the hepatitis C virus during treatment. Talk with your healthcare provider about ways to prevent spreading the hepatitis C virus.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOVALDI for a condition for which it was not prescribed. Do not give SOVALDI to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information about SOVALDI, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SOVALDI that is written for health professionals.
For more information, call 1-800-445-3235 or go to www.SOVALDI.com.
What are the ingredients in SOVALDI?
Active ingredient: sofosbuvir
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose.
The tablet film-coat contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 4/6/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Sovaldi Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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