Elbasvir and grazoprevir are antiviral medicines that prevent hepatitis C (HCV) from multiplying in your body.

Elbasvir and grazoprevir is a combination medicine used to treat chronic hepatitis C in adults. This medicine is sometimes given together with another drug called ribavirin.

Elbasvir and grazoprevir 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.

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

Elbasvir and grazoprevir may also be used for purposes not listed in this medication guide.

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

• moderate or severe liver disease.

When taking elbasvir and grazoprevir 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.

Elbasvir and grazoprevir 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.

Elbasvir and grazoprevir is not approved for use by anyone younger than 18 years old.

Use Elbasvir And Grazoprevir (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

In rare cases, elbasvir and grazoprevir 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 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.

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.