Sovaldi

Generic Name: sofosbuvir (soe FOS bue vir)
Brand Names: Sovaldi

What is Sovaldi?

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

Sovaldi is used in combination with other medications to treat hepatitis C in adults. Sovaldi 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).

Important information

Sovaldi 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

Before taking this medicine

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);

FDA Pregnancy Category X. 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

  • 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 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.

How should I take Sovaldi?

Do not take Sovaldi 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.

Sovaldi 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 Sovaldi, you may need frequent blood tests.

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

Sovaldi 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): Sovaldi, peginterferon alfa, and ribavirin
-Genotype 2 CHC: Sovaldi and ribavirin
-Genotype 3 CHC: Sovaldi and ribavirin
-Hepatocellular carcinoma awaiting liver transplantation: Sovaldi 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.
-Sovaldi 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.
-Sovaldi 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 Sovaldi?

Avoid taking an herbal supplement containing St. John's wort while you are 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.

Sovaldi side effects

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;

  • fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough.

Common Sovaldi 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.

See also: Side effects (in more detail)

What other drugs will affect Sovaldi?

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

  • rifabutin;

  • tipranavir;

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

  • tuberculosis medication - 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.

Where can I get more information?

  • Your pharmacist can provide more information about Sovaldi.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-01-16, 8:49:39 AM.

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