Sofosbuvir

Brand(s)

Manufacturer

• Mylan Pharmaceuticals

Disease(s)

• Hepatitis C / HIV

Sofosbuvir tablet

What is this medicine?

SOFOSBUVIR is an antiviral medication that prevents hepatitis C virus (HCV) from multiplying in your body.

Sofosbuvir 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.

Sofosbuvir must be given in combination with other antiviral medications and should not be used alone. Sofosbuvir is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron).

Sofosbuvir is also used together with Daklinza (daclatasvir) to treat hepatitis C genotype 3 infection in adults.

Important information

Sofosbuvir 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.

Ribavirin 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 medicine

You should not use Sofosbuvir you are allergic to sofosbuvir.

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.

• If you are a woman, do not use Sofosbuvir 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 Sofosbuvir 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.

How should I take Sofosbuvir?

Do not take Sofosbuvir as your only medication to treat hepatitis C. It must be used in combination with other antiviral medication. Your disease may become resistant if you do not take it in combination with other medicines your doctor has prescribed.

Sofosbuvir is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food. Take the medicine at the same time each day.

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. Every person with hepatitis C should remain under the care of a doctor.

While using Sofosbuvir, you may need frequent blood tests.

Store this medicine in the original container at room temperature away from moisture and heat.

Sofosbuvir dosing information

Usual Adult Dose for Chronic Hepatitis C:

400 mg orally once a day

Recommended Regimens:
-Genotype 1 or 4 chronic hepatitis C (CHC): Sofosbuvir, peginterferon alfa, and ribavirin
-Genotype 2 CHC: Sofosbuvir and ribavirin
-Genotype 3 CHC: Sofosbuvir and ribavirin
-Hepatocellular carcinoma awaiting liver transplantation: Sofosbuvir and ribavirin

Duration of Therapy:
-Genotype 1 or 4 CHC: 12 weeks
-Genotype 2 CHC: 12 weeks
-Genotype 3 CHC: 24 weeks
-Hepatocellular carcinoma awaiting liver transplantation: Up to 48 weeks or until time of liver transplantation (whichever occurs first)

Comments:
-Sofosbuvir 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 benefits/risks assessment for the individual patient.
-Sofosbuvir and ribavirin therapy is recommended for patients with hepatocellular carcinoma awaiting liver transplantation to prevent posttransplant HCV reinfection.

Approved indication: As a part of a combination antiviral treatment regimen, for the treatment of chronic hepatitis C infection

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 Sofosbuvir?

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.

Sofosbuvir side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Sofosbuvir: 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 Sofosbuvir side effects may include:

• headache, tired feeling;

• mild itching;

• nausea;

• 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?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sofosbuvir, especially:

• amiodarone;

• St. John's wort;

• tipranavir;

• seizure medication - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

• tuberculosis medication - rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with sofosbuvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

How to store this medicine?

At a temperature of 15 to 30°C.

The most accurate recommendations for dosage and duration of treatment can be obtained from the attending physician, who prescribes the medicine based on the individual characteristics of the patient.