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Common Use
The active ingredient present in Sovaldi is Sofosbuvir – 400 mg. Sofosbuvir is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. Sofosbuvir is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3, and 4, in combination with pegylated interferon and ribavirin, or with ribavirin alone. It is also used in combination with the viral NS5a inhibitor ledipasvir in an interferon-free combination for the treatment of genotype 1 hepatitis C infection. Sofosbuvir is also used in HCV patients with an HIV coinfection. The treatment is based on a number of clinical trials, for example the ELECTRON trial which showed that a dual interferon-free regimen of sofosbuvir plus ribavirin produced a 24-week post-treatment sustained virological response (SVR24) rate of 100% for previously untreated patients with HCV genotypes 2 or 3. It is not known if sofosbuvir is safe and effective in children under 18 years of age.
Dosage and direction
Usual Adult Dose for Chronic Hepatitis C is 400 mg orally once a day Recommended Regimens and Duration of Therapy: -Genotype 1 or 4 chronic hepatitis C (CHC): Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks -Genotype 2 CHC: Sofosbuvir and ribavirin for 12 weeks -Genotype 3 CHC: Sofosbuvir and ribavirin for 24 weeks -Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin for up to 48 weeks or until liver transplantation (whichever occurs first) This drug should be used in combination with ribavirin or with pegylated interferon and ribavirin. Efficacy was established in patients with HCV genotype 1, 2, 3, or 4 infection, including patients with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and HCV/HIV-1 coinfected patients. Sofosbuvir and ribavirin therapy for 24 weeks can be considered for patients with genotype 1 CHC who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient. Sofosbuvir and ribavirin therapy is recommended for patients with hepatocellular carcinoma awaiting liver transplantation to prevent posttransplant HCV reinfection.
Precautions
It is strongly recommended to consult your doctor or pharmacist before you start taking Sovaldi and especially emphasize if you are allergic to this drug or if you take other medicines to treat Hepatitis C. To make sure sofosbuvir 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); -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. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using sofosbuvir with ribavirin. If you are a man, do not use this drug combination if your sexual partner is pregnant. 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. 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. Contraindications Drinking alcohol while taking Sovaldi can cause dangerous or unwanted side effects. Grapefruit and grapefruit juice may interact with sofosbuvir and lead to unwanted side effects. Avoid the use of grapefruit products while taking Sovaldi.
Possible side effect
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 side effects may include: headache, tired feeling; mild itching; nausea; sleep problems. This is not a complete list of side effects and others may occur. Call your doctor for or pharmacist medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interaction
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of these medicines: Amiodarone; Carbamazepine; Eliglustat; Fosphenytoin; Oxcarbazepine; Phenobarbital; Phenytoin; Primidone; Rifabutin; Rifampin; Rifapentine; St John’s Wort; Tipranavir; Ulipristal Missed 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. Overdose If you think you have used too much of Sovaldi – seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Storage
Store this medicine at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F) away from moisture and heat. Keep all drugs out of the reach children and pets.