Sofosbuvir

By

Generic Name: Sofosbuvir Brand Name(s): Generics only. No brands available.

Uses

What is Sofosbuvir used for?

Sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.

Sofosbuvir in combination with other antiviral medications reduces the amount of hepatitis C virus in the body and helps the body’s immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice “safer sex” (including the use of latex condoms) to lower the risk of passing the virus to others.

Sofosbuvir must be used in combination treatment to have the best effect. Do not use sofosbuvir alone to treat hepatitis C.

How should I take Sofosbuvir?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Continue to take sofosbuvir and your other antiviral medication(s) for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping any of the drugs too early may result in a return of the infection.

How do I store Sofosbuvir?

Sofosbuvir is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Sofosbuvir in the bathroom or the freezer. There may be different brands of Sofosbuvir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Sofosbuvir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Sofosbuvir?

Before taking sofosbuvir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, other liver problems (such as hepatitis B).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, sofosbuvir should be used only when clearly needed. Sofosbuvir, in combination with ribavirin or peginterferon, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for six months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Breast-feeding while using sofosbuvir, in combination with ribavirin or peginterferon, is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Sofosbuvir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sofosbuvir. Sofosbuvir is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Sofosbuvir?

Tiredness, headache, nausea, diarrhea, itchy skin, difficulty sleeping, or irritability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low red blood cell count (such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Sofosbuvir?

A product that may interact with this drug is: amiodarone.

Other medications can affect the removal of sofosbuvir from your body, which may affect how sofosbuvir works. Examples include rifamycins (such as rifampin, rifabutin), St. John’s wort, tipranavir/ritonavir, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), among others.

Do not take this medication with other products that contain sofosbuvir.

Sofosbuvir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Sofosbuvir?

Sofosbuvir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sofosbuvir?

Sofosbuvir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Sofosbuvir.

What is the dose of Sofosbuvir for an adult?

Usual Adult Dose for Chronic Hepatitis C

400 mg orally once a day

Recommended Regimen and Duration of Therapy:

-Genotype 1 or 4: Sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks

-Genotype 2: Sofosbuvir and ribavirin for 12 weeks

-Genotype 3: 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)

Comments:

-Genotype 1, 4: This regimen is recommended for therapy-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).

-Genotype 2, 3: Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).

-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).

-The dose recommendations for genotype 1, 2, 3, or 4 should be followed for HCV/HIV-1-coinfected patients.

-The manufacturer product information should be consulted for ribavirin dose recommendations; with genotype 1 or 4, the manufacturer product information for peginterferon alfa should also be consulted for dose recommendations.

-Sofosbuvir and ribavirin for 24 weeks can be considered for patients with genotype 1 infection who cannot use an interferon-based regimen; treatment decision should be guided by benefit/risk assessment for the individual patient.

-The regimen for patients with hepatocellular carcinoma awaiting liver transplantation is recommended to prevent posttransplant HCV reinfection.

Use: As a part of a combination antiviral treatment regimen, for the treatment of chronic HCV infection

-In combination with pegylated interferon and ribavirin: For genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis

-In combination with ribavirin: For genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild or moderate renal dysfunction: No adjustment recommended.

Severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73 m2): Data not available

Comments:

-Safety and efficacy of this drug not established in patients with severe renal dysfunction.

-The manufacturer product information for ribavirin and peginterferon alfa should be consulted for patients with CrCl less than 50 mL/min.

Liver Dose Adjustments

Mild, moderate, or severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Comments:

-Safety and efficacy of this drug not established in patients with decompensated cirrhosis.

-The manufacturer product information for peginterferon alfa should be consulted for contraindication in hepatic decompensation.

Dose Adjustments

Dose reduction of this drug is not recommended.

If a serious side effect potentially related to peginterferon alfa and/or ribavirin develops, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued, if appropriate, until the side effect abates or decreases in severity. The manufacturer product information for peginterferon alfa and ribavirin should be consulted for information regarding dose reduction and/or discontinuation.

If the other drugs used in combination with this drug are permanently discontinued, this drug should also be discontinued.

What is the dose of Sofosbuvir for a child?

Usual Pediatric Dose for Chronic Hepatitis C

12 years and older or weighing at least 35 kg: 400 mg orally once a day

Recommended Regimen and Duration of Therapy:

-Genotype 2: Sofosbuvir and ribavirin for 12 weeks

-Genotype 3: Sofosbuvir and ribavirin for 24 weeks

Comments:

-Both regimens are recommended for therapy-naive and therapy-experienced patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).

-Therapy-experienced patients have failed an interferon-based regimen (with or without ribavirin).

-The manufacturer product information should be consulted for ribavirin dose recommendations.

-The same dose recommendations should be followed for HCV/HIV-1-coinfected patients.

Use: In combination with ribavirin, for the treatment of chronic HCV genotype 2 or 3 infection in patients without cirrhosis or with compensated cirrhosis

Precautions

HCV genotype 1 or 4: Safety and efficacy have not been established in patients younger than 18 years.

HCV genotype 2 or 3: Safety and efficacy have not been established in patients younger than 12 years and weighing less than 35 kg.

How is Sofosbuvir available?

Sofosbuvir is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sofosbuvir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: April 26, 2018

You might also like