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Indications: The following indications for sofosbuvir relate to patients with chronic hepatitis C virus infection.
Sofosbuvir is indicated for treatment of patients with chronic HCV
Genotype 1 or 4: sofosbuvir plus peginterferon-alfa plus ribavirin for 12 weeksGenotype 2: sofosbuvir plus ribavirin for 12 weeksGenotype 3: sofosbuvir plus ribavirin for 24 weeksFor the treatment of patients with HCV-HIV-1 coinfection: the recommendations are the same as listed above.
For patents with genotype 1 HCV who are not eligible to receive interferon: sofosbuvir plus ribavirin for 24 weeks can be considered.
For patients with HCV and hepatocellular carcinoma awaiting liver transplantation: sofosbuvir plus ribavirin for a duration of up to 48 weeks or until liver transplantation, whichever occurs first.
DOSAGE AND ADMINISTRATION
The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of CHC in adults
What is Sovaldi?
Sovaldi (sofosbuvir) is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body.
Sovaldi is used in combination with other medications to treat hepatitis C in adults. Sofosbuvir is sometimes used in people who also have HIV, or people who have liver cancer and are going to have a liver transplant. This medicine is not a treatment for HIV or AIDS.
Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sovaldi is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron).
Sovaldi is also used together with Daklinza (daclatasvir) to treat hepatitis C genotype 3 infection in adults.
Important informationSovaldi 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.
The ABC's of Hepatitis: Get to Know This Viral DiseaseRibavirin 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.
Before taking this medicineYou should not use Sovaldi you are allergic to sofosbuvir.
To make sure Sovaldi is safe for you, tell your doctor if you have:
-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);
-if you have recently used a heart rhythm medicine called amiodarone (Cordarone, Pacerone).
Sovaldi 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.
-If you are a woman, do not use Sovaldi with ribavirin if you are pregnant.
-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 Sovaldi 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.
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 Sovaldi?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.
Get emergency medical help if you have any of these signs of an allergic reaction to Sovaldi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough.
Common Sovaldi side effects may include:
headache, tired feeling;
sleep problems (insomnia);