Zepatier contains a combination of elbasvir and grazoprevir. Elbasvir and grazoprevir are antiviral medicines that prevent hepatitis C (HCV) from multiplying in your body.

Zepatier is used to treat chronic hepatitis C (HCV) in adults and children 12 years of age and older or weighing at least 66 pounds (30 kilograms). This medicine is sometimes given together with another drug called ribavirin.

Zepatier treats specific genotypes (1 or 4) of HCV infection, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.

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

You should not use Zepatier if you have moderate or severe liver disease.

Serious drug interactions can occur when certain medicines are used together with elbasvir and grazoprevir. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

If you've ever had hepatitis B, using Zepatier can cause this virus to become active or get worse. Tell 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.

Before taking this medicine

You should not use Zepatier if you are allergic to elbasvir or grazoprevir, or if you have:

• moderate or severe liver disease.

When Zepatier with ribavirin: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with elbasvir and grazoprevir.

Your doctor may change your treatment plan if you also use:

• cyclosporine;

• rifampin;

• St. John's wort;

• HIV or AIDS medication - atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or

• seizure medicine - carbamazepine, phenytoin.

Tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• HIV (human immunodeficiency virus);

• a liver transplant, or if you are waiting to have a liver transplant; or

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

Zepatier is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Zepatier is not approved for use by anyone younger than 18 years old.

Take Zepatier exactly as prescribed by your doctor. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Zepatier.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Zepatier with or without food.

Take the medicine at the same time each day.

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

If you've ever had hepatitis B, using Zepatier can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

You should not stop using Zepatier suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.

Use all hepatitis C medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.

Usual Adult Dose for Chronic Hepatitis C:

1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced without baseline nonstructural protein 5A (NS5A) polymorphisms: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced with baseline NS5A polymorphisms: Elbasvir-grazoprevir plus ribavirin for 16 weeks
-Genotype 1b, therapy-naive or peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a or 1b, peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Elbasvir-grazoprevir plus ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir plus ribavirin for 16 weeks

Comments:
-This drug should be used with ribavirin in certain patient populations.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-Baseline NS5A polymorphisms: NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.
-Peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin plus HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, telaprevir)
-Optimal regimen and duration of therapy not established for peginterferon alfa/ribavirin/HCV protease inhibitor-experienced genotype 1a-infected patients with at least 1 baseline NS5A resistance-associated polymorphism at positions 28, 30, 31, and 93.
-The manufacturer product information for ribavirin tablets should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV genotype 1 or 4 infection

Usual Pediatric Dose for Chronic Hepatitis C:

12 years and older OR weighing at least 30 kg: 1 tablet orally once a day

Recommended Regimen and Duration of Therapy:
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced without baseline NS5A polymorphisms: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a, therapy-naive or peginterferon alfa/ribavirin-experienced with baseline NS5A polymorphisms: Elbasvir-grazoprevir plus ribavirin for 16 weeks
-Genotype 1b, therapy-naive or peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir for 12 weeks
-Genotype 1a or 1b, peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Elbasvir-grazoprevir plus ribavirin for 12 weeks
-Genotype 4, therapy-naive: Elbasvir-grazoprevir for 12 weeks
-Genotype 4, peginterferon alfa/ribavirin-experienced: Elbasvir-grazoprevir plus ribavirin for 16 weeks

Comments:
-This drug should be used with ribavirin in certain patient populations.
-Hepatic laboratory testing recommended prior to and during therapy.
-Peginterferon alfa/ribavirin-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin
-Baseline NS5A polymorphisms: NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93.
-Peginterferon alfa/ribavirin/HCV protease inhibitor-experienced: Patients who have failed therapy with peginterferon alfa plus ribavirin plus HCV NS3/4A protease inhibitor (e.g., boceprevir, simeprevir, telaprevir)
-Optimal regimen and duration of therapy not established for peginterferon alfa/ribavirin/HCV protease inhibitor-experienced genotype 1a-infected patients with at least 1 baseline NS5A resistance-associated polymorphism at positions 28, 30, 31, and 93.
-The manufacturer product information for ribavirin tablets should be consulted regarding dosing and dose adjustments (if applicable).

Use: For the treatment of chronic HCV genotype 1 or 4 infection

You should not use Zepatier if you are allergic to elbasvir or grazoprevir, or if you have:

• moderate or severe liver disease.

When Zepatier with ribavirin: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with elbasvir and grazoprevir.

Your doctor may change your treatment plan if you also use:

• cyclosporine;

• rifampin;

• St. John's wort;

• HIV or AIDS medication - atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or

• seizure medicine - carbamazepine, phenytoin.

Tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis C;

• HIV (human immunodeficiency virus);

• a liver transplant, or if you are waiting to have a liver transplant; or

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

Zepatier is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Zepatier is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent your disease from spreading. 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.

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

In rare cases, Zepatier may cause serious liver injury. Tell your doctor right away if you have symptoms such as:

• right-sided upper stomach pain or swelling;

• nausea, vomiting, loss of appetite;

• confusion, tiredness, feeling light-headed;

• easy bruising or bleeding, vomiting blood;

• diarrhea, black or bloody stools;

• dark urine, clay-colored stools; or

• yellowing of your skin or eyes.

If you also take ribavirin, tell your doctor if you have symptoms of low red blood cells (anemia):

• pale skin, cold hands and feet;

• unusual tiredness, feeling light-headed; or

• shortness of breath.

Common Zepatier side effects may include:

• headache;

• tiredness;

• anemia; or

• nausea.

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.

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

Many drugs can interact with elbasvir and grazoprevir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.