Elbasvir and grazoprevir

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

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

Elbasvir and grazoprevir treats specific types of hepatitis C, and only in certain individuals. 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 reasons not mentioned in this medication guide.

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

Follow all instructions 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 every day.

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

If you have ever had hepatitis B, using elbasvir and grazoprevir can cause this virus to become active or worsen. You may need regular 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 elbasvir and grazoprevir if you have moderate or severe liver disease.

Tell your doctor about all your current medicines and any that you start or stop. 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 worsen. Tell your doctor if you feel unwell and have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

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.

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.

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

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

Using elbasvir and grazoprevir will not stop your disease from spreading. 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.

When you begin or stop taking elbasvir and grazoprevir, your doctor may need to change the doses of any other medicines you regularly take.

Many medications can influence how elbasvir and grazoprevir work, and some medications should not be taken together. Inform your doctor about all the medicines you are currently taking and any new medicines you start or stop. This includes prescription and over-the-counter medications, vitamins, and herbal products. Not all possible interactions are mentioned here.