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. elbasvir and grazoprevir 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 elbasvir and grazoprevir if you have moderate or severe liver disease.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

If you've ever had hepatitis B, using elbasvir and grazoprevir 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.

The combination of elbasvir and grazoprevir comes as a tablet to take by mouth. It is usually taken with or without food once daily for 12 to 16 weeks. Take elbasvir and grazoprevir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elbasvir and grazoprevir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take elbasvir and grazoprevir even if you feel well. The length of your treatment depends on your condition, how well you respond to the medication, and whether you experience severe side effects. Do not stop taking elbasvir and grazoprevir without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

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

You may take elbasvir and grazoprevir 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 elbasvir and grazoprevir can cause this virus to become active or get worse. You may need frequent liver function tests while using elbasvir and grazoprevir and for several months after you stop.

You should not stop using elbasvir and grazoprevir 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.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove tablets from the packaging until just before use.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Using elbasvir and grazoprevir 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: 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 of elbasvir and grazoprevir 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 elbasvir and grazoprevir, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect 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.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.