Generic Name: elbasvir and grazoprevir
Date of Approval: January 28, 2015
Company: Merck & Co. Inc.
Treatment for: Hepatitis C Genotypes 1 and 4
FDA Approves Zepatier
The U.S. FDA has approved Zepatier (elbasvir and grazoprevir), a once-daily NS5A inhibitor and NS3/4A protease inhibitor fixed-dose combination for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.
Before you take this medicine, be sure you understand what it is for and how to take it safely. Read this patient information leaflet before you start treatment and every time you get a refill. There may be new information. If you have questions about this medicine, ask your healthcare provider or pharmacist.
Your healthcare provider may prescribe Zepatier with a medicine called ribavirin. Ribavirin is also known as Rebetol, Copegus, Ribasphere, and Moderiba. If you take Zepatier and ribavirin, be sure you also read the Medication Guide for ribavirin.
What is Zepatier?
Zepatier is a prescription medicine used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults.
It is not known if Zepatier is safe or effective in children under 18 years old, people awaiting a liver transplant, or people who have had a liver transplant.
Who should not take Zepatier?
Do not take Zepatier if you have certain liver problems.
Before taking Zepatier
Before taking Zepatier, tell your healthcare provider if you:
- have liver problems other than hepatitis C
- have ever taken any medicine for hepatitis C
- have HIV
- have had or are waiting for a liver transplant
- have any other medical conditions
- are pregnant or trying to get pregnant. Zepatier has not been studied in pregnant women and it is not known if it will harm your baby while you are pregnant.
- Males and females who take Zepatier and ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
- are breastfeeding or plan to breastfeed. It is not known if Zepatier passes into breast milk and if it can be passed on to your baby.
- Talk to your healthcare provider about the best way to feed your baby during treatment with Zepatier.
Tell your healthcare provider about all of the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Zepatier may affect the way other medicines work, and vice versa. Some medicines cannot be taken with Zepatier. Your healthcare provider can tell you if it is safe to take Zepatier with other medicines.
- Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
- You can ask your healthcare provider or pharmacist for a list of medicines that interact with this medicine.
- Do not start taking a new medicine without telling your healthcare provider.
How do I take Zepatier?
- Take one Zepatier tablet at the same time every day.
- The tablets come individually-packaged in blister packages. Keep the tablets in this package until you are ready to take your dose.
- Take your dose exactly as your healthcare provider tells you to take it.
- The tablets can be taken with or without food.
- Do not stop your treatment without first talking with your healthcare provider.
- If you take more than your prescribed dose, call your healthcare provider right away.
What if I forget to take Zepatier?
- Do not take two doses of Zepatier at the same time to make up for a missed dose.
- If you are not sure what to do, call your healthcare provider or pharmacist. It is important that you do not miss or skip doses during your treatment.
Zepatier side effects
Zepatier may cause serious side effects including:
- Signs of liver problems. Zepatier may cause increases in your liver-related blood tests. This could be a sign of serious liver problems. Your healthcare provider will do blood tests to check your liver before and during treatment with. Tell your healthcare provider right away if you get any of the following symptoms or if they get worse during treatment:
- loss of appetite
- nausea and vomiting
- feeling tired or weak
- yellowing of your skin or eyes
- color changes in your stool
Common side effects of Zepatier when used without ribavirin include:
- feeling tired
- trouble sleeping
Common side effects of Zepatier when used with ribavirin include:
- low red blood cell counts (anemia)
- feeling tired
- shortness of breath
- rash or itching
- feeling irritable
- stomach pain
- joint pain
If you have any side effect that bothers you or that does not go away, tell your healthcare provider.
There may be other side effects that are not listed. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information or medical advice call your doctor.
How should I store Zepatier?
- Keep Zepatier in its original packaging (blister package) until you are ready to take it. Do not take the tablets out of the original blister package to store in another container such as a pill box. This is important because the tablets are sensitive to moisture. The package is designed to protect them.
- Store the tablets at room temperature.
Keep all medicines out of the reach of children and pets.
General information about Zepatier
- Medicines are sometimes prescribed for purposes other than those listed in the patient information. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition. It may harm them.
- If you would like more information, talk with your healthcare provider or pharmacist. You can ask them for information that was written for health professionals.
- For more information, call Merck 1-877-888-4231 or go to www.Zepatier.com.
What are the ingredients in Zepatier?
Active ingredients: elbasvir and grazoprevir.
Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, sodium chloride, sodium lauryl sulfate, and vitamin E polyethylene glycol succinate.
The tablets are film-coated with a coating material containing the following inactive ingredients: carnauba wax, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.