Epclusa

Generic name: Sofosbuvir And Velpatasvir
Drug class: Antiviral combinations

Usage of Epclusa

Epclusa contains a combination of sofosbuvir and velpatasvir. Sofosbuvir and velpatasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Epclusa is used to treat chronic hepatitis C in adults and children 3 years of age and older (dosage is based on weight). It is sometimes given in combination with another antiviral medicine called ribavirin in people who also have advanced cirrhosis.

Epclusa treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

Epclusa is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.

Epclusa side effects

Get emergency medical help if you have signs of an allergic reaction to Epclusa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening symptoms such as:

right-sided upper stomach pain;

vomiting, loss of appetite, not feeling well; or

jaundice (yellowing of the skin or eyes).

If you also take a heart rhythm medicine called amiodarone: Taking amiodarone with Epclusa can cause dangerous side effects on your heart. Get medical help right away if you take this medicine and you have:

very slow heartbeats, chest pain, shortness of breath;

confusion, memory problems; or

weakness, extreme tiredness, light-headed feeling (like you might pass out).

Common Epclusa side effects may include:

headache, tiredness;

nausea, vomiting, diarrhea;

sleep problems (insomnia); or

low red blood cells (anemia) in people with cirrhosis - pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

Before taking Epclusa

Epclusa is sometimes used in combination with other antiviral medication. Read the medication guide or patient instructions provided with each medication in your combination therapy.

When taking Epclusa with other medicine: Tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

To make sure Epclusa is safe for you, tell your doctor if you have:

hepatitis B;

liver problems other than hepatitis C;

kidney disease (or if you are on dialysis);

diabetes;

HIV (human immunodeficiency virus); or

if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.

Epclusa is sometimes used in combination with ribavirin. Both men and women using ribavirin should use birth control to prevent pregnancy. Ribavirin can harm an unborn baby if the mother or father is using ribavirin. Keep using birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs.

Ask a doctor if it is safe to breastfeed while using these medicines.

Relate drugs

How to use Epclusa

Usual Adult Dose for Chronic Hepatitis C:

Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day Recommended Regimen and Duration of Therapy: -Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks -Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks Comments: -Dose recommendations also apply to HCV/HIV-1-coinfected patients. -In clinical trials, therapy-experienced patients received a peginterferon alfa/ribavirin-based regimen with or without an HCV nonstructural protein 3/4A (NS3/4A) protease inhibitor (Boceprevir, simeprevir, or telaprevir). -If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments. Uses: For the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection -In patients without cirrhosis or with compensated cirrhosis -In combination with ribavirin: In patients with decompensated cirrhosis

Usual Pediatric Dose for Chronic Hepatitis C:

6 years or older: -Weight 17 to less than 30 kg: Sofosbuvir 200 mg-velpatasvir 50 mg orally once a day -Weight at least 30 kg: Sofosbuvir 400 mg-velpatasvir 100 mg orally once a day Recommended Regimen and Duration of Therapy: -Therapy-naive and therapy-experienced, without cirrhosis and with compensated cirrhosis (Child-Pugh A): Sofosbuvir-velpatasvir for 12 weeks -Therapy-naive and therapy-experienced, with decompensated cirrhosis (Child-Pugh B or C): Sofosbuvir-velpatasvir plus ribavirin for 12 weeks Comments: -Dose recommendations also apply to HCV/HIV-1-coinfected patients. -In clinical trials, therapy-experienced adults received a peginterferon alfa/ribavirin-based regimen with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). -If applicable, the manufacturer product information should be consulted for ribavirin dose recommendations; the manufacturer product information for ribavirin should be consulted for further information regarding dosing and dose adjustments. Uses: For the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection -In patients without cirrhosis or with compensated cirrhosis -In combination with ribavirin: In patients with decompensated cirrhosis

Warnings

If you've had hepatitis B, Epclusa can cause this condition to come back or get worse. Call your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

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.

Epclusa is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Do not use ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Use effective birth control to prevent pregnancy while using these medicines together and for at least 6 months after treatment ends.

What other drugs will affect Epclusa

When you start or stop taking Epclusa, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you also take omeprazole (Prilosec) or an antacid, do not take it for at least 4 hours after you have taken your dose of Epclusa (with food).

Many drugs can interact with sofosbuvir and velpatasvir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Disclaimer

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