Velpanat® (Velpatasvir + Sofosbuvir)

What is sofosbuvir and velpatasvir?

Sofosbuvir and velpatasvir are antiviral medications that prevent hepatitis C virus (HCV) from multiplying in your body.

Sofosbuvir and velpatasvir is a combination medicine used to treat chronic hepatitis C in adults with HCV genotype 1, 2, 3, 4, 5, or 6.

This medicine is given in combination with another antiviral medicine called ribavirin in people who also have advanced cirrhosis.

Sofosbuvir and velpatasvir may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sofosbuvir and velpatasvir?

Sofosbuvir and velpatasvir 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.

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.

If you have ever had hepatitis B, sofosbuvir and velpatasvir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.

What should I discuss with my healthcare provider before taking sofosbuvir and velpatasvir?

You should not use this medicine if you are allergic to sofosbuvir or velpatasvir.

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

• a history of hepatitis B;

• kidney disease (or if you are on dialysis);

• liver problems other than hepatitis;

• HIV (human immunodeficiency virus); or

• if you have recently used a heart rhythm medicine called amiodarone (Cordarone, Pacerone).

It is not known whether sofosbuvir and velpatasvir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine is sometimes 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 and velpatasvir 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 effective birth control to prevent pregnancy while either sexual partner is using these medications together. Keep using this 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 and velpatasvir with ribavirin.

It is not known whether sofosbuvir and velpatasvir 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 and velpatasvir?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

Sofosbuvir and velpatasvir is usually taken once per day for 12 weeks. 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.

You will need frequent blood tests to check your liver function.

Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

You should not stop using sofosbuvir and velpatasvir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

If you have ever had hepatitis B, sofosbuvir and velpatasvir can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.

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

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.
 

What should I avoid while taking sofosbuvir and velpatasvir?

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 sofosbuvir and velpatasvir (with food).

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 and velpatasvir side effects

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

Call your doctor at once if you have:

• slow heartbeats;

• weak or shallow breathing; or

• low red blood cells--pale skin, weakness, rapid heart rate, trouble concentrating.

If you also take amiodarone: Seek medical help right away if you feel weak, tired, or light-headed, or if you have chest pain, shortness of breath, confusion, or memory problems.

Common side effects may include:

• headache;

• tired feeling;

• nausea, diarrhea; or

• sleep problems (insomnia).

What other drugs will affect sofosbuvir and velpatasvir?

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.

Other drugs may interact with sofosbuvir and velpatasvir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.