Elbasvir / grazoprevir

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 genotype 1 or 4 in adults. This medicine is sometimes given together with another drug called ribavirin (Copegus, Rebetol, Moderiba, Ribasphere).

Elbasvir and grazoprevir is used only if your HCV has a specific genetic marker, for which your doctor will test.

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

You should not use this medicine 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.

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

• moderate or severe liver disease.

Some medicines can cause unwanted or dangerous effects when used with elbasvir and grazoprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;
• rifampin;
• St. John's wort;
• HIV or AIDS medication--atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or
• seizure medicine--carbamazepine, phenytoin.

To make sure elbasvir and grazoprevir is safe for you, tell your doctor if you have:

• liver problems other than hepatitis, or if you have had a liver transplant;
• HIV (human immunodeficiency virus); or
• if you are waiting to have a liver transplant.

It is not known whether this medicine will harm an unborn baby. Elbasvir and grazoprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. 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 elbasvir and grazoprevir 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 at least 2 effective forms of non-hormonal birth control (condom, diaphragm with spermicide) while either sexual partner is using these medications together. Keep using 2 forms of 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 elbasvir and grazoprevir with ribavirin.

It is not known whether elbasvir and grazoprevir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

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. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take elbasvir and grazoprevir with or without food.

Take the medicine at the same time each day.

Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HCV should remain under the care of a doctor.

While using elbasvir and grazoprevir, you may need frequent blood tests to check your liver function.

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

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

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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Anticonvulsants
  • phenytoin (Dilantin)
  • carbamazepine (Tegretol)
• Antimycobacterials
  • rifampin (Rifadin)
• Herbal Products
  • St. John's wort (Hypericum perforatum)
• HIV Medications
  • efavirenz (Sustiva, Stocrin)
  • atazanavir (Reyataz)
  • darunavir (Prezista)
  • lopinavir/ritonavir (Kaletra)
  • saquinavir (Invirase, Fortovase)
  • tipranavir (Aptivus)
• Immunosuppressants
  • cyclosporine (Neoral, Sandimmune)
• Statins used to lower cholesterol such as atorvastatin and rosuvastatin

This is not a complete list of elbasvir and grazoprevir drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with elbasvir and grazoprevir including the following:

• ALT Elevations (a rise in liver enzymes in the blood which indicates liver damage). Tell your healthcare provider right away if you have some or all of the following symptoms of ALT Elevations
  • fatigue
  • weakness
  • lack of appetite
  • nausea and vomiting
  • jaundice (yellow skin or whites of the eyes)
  • discolored feces
• Risks Associated with Ribavirin Combination Treatment
  • see Drug Precautions for ribavirin

Contact your healthcare provider immediately if you develop weakness, fatigue, nausea, vomiting, yellow eyes or skin, loss of appetite, or light-colored stools. These may be signs and symptoms of a serious liver problem. 

Do not take elbasvir and grazoprevir if you:

• are allergic to elbasvir and grazoprevir or to any of its ingredients
• have moderate or severe hepatic impairment (Child-Pugh B or C)
• are taking certain medications such as OATP1B1/3 inhibitors, strong CYP3A inducers, or efavirenz (tell your doctor about all the medicines you take)

Before taking elbasvir and grazoprevir, tell your doctor about all of your medical conditions. Especially tell your doctor if you have liver problems other than hepatitis C.

• are allergic to elbasvir and grazoprevir or to any of its ingredients
• have ever taken any medicine for hepatitis C
• if you have a history of hepatitis B infection
• have HIV
• have had or are waiting for a liver transplant
• have any other medical conditions
• are pregnant or trying to get pregnant. elbasvir and grazoprevir have not been studied in pregnant women. We do not know if elbasvir and grazoprevir will harm your baby while you are pregnant.
• are breastfeeding or plan to breastfeed. We do not know if elbasvir and grazoprevir gets in your breast milk and gets passed to your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with elbasvir and grazoprevir.

Males and females who take elbasvir and grazoprevir and ribavirin should also read the ribavirin drug precautions for important pregnancy, contraception, and infertility information.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in pregnant women with elbasvir and grazoprevir. It is not known if elbasvir and grazoprevir will harm your baby while you are pregnant.

Males and females who take this medication and ribavirin should also read the ribavirin medication guide for important pregnancy, contraception, and infertility information.

If you take too much elbasvir and grazoprevir, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

In the U.S.

• Zepatier

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiviral

Pharmacologic Class: Hepatitis C Virus NS5A Inhibitor

It is very important that your doctor check your progress at regular visits to make sure elbasvir/grazoprevir is working properly. Blood tests may be needed to check for unwanted effects.

Using elbasvir/grazoprevir together with ribavirin while you are pregnant can harm your unborn baby. Birth defects may occur if the father is using elbasvir/grazoprevir when his sexual partner becomes pregnant. If a pregnancy occurs while you are using elbasvir/grazoprevir, tell your doctor right away.

Do not use the following medicines while you are using Zepatier™: cyclosporine (Gengraf®, Neoral®, Sandimmune®), rifampin (Rifadin®, Rimactane®), St John's wort, medicine to treat HIV infection (such as atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir, Invirase®, Kaletra®, Reyataz®, Sustiva®), or medicine to treat seizures (such as carbamazepine, phenytoin, Dilantin®, Tegretol®).

Check with your doctor right away if you are weak or fatigued, have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.