Elbasvir and Grazoprevir

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, taking the combination of elbasvir and grazoprevir may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or ever had a hepatitis B virus infection. Your doctor will order a blood test to see if you have or have ever had hepatitis B infection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If necessary, your doctor may give you medication to treat this infection before and during your treatment with the combination of elbasvir and grazoprevir. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness; yellowing of skin or eyes; loss of appetite; nausea or vomiting; pale stools; pain in upper right side of the stomach area; or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before, during, and after your treatment to check your body's response to the combination of elbasvir and grazoprevir.

Talk to your doctor about the risk(s) of taking the combination of elbasvir and grazoprevir.

The combination of elbasvir and grazoprevir is used alone or in combination with ribavirin (Copegus, Rebetol, Ribasphere, Virazole) to treat a certain type of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults and children 12 years of age or older. Elbasvir is in a class of antiviral medications called HCV NS5A inhibitors. It works by stopping the virus that causes hepatitis C from spreading inside the body. Grazoprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. It is not known if elbasvir and grazoprevir prevent the spread of hepatitis C to other people.

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking elbasvir and grazoprevir,

• tell your doctor and pharmacist if you are allergic to elbasvir, grazoprevir, any other medications, or any of the ingredients in elbasvir and grazoprevir tablets. Ask your pharmacist for a list of the ingredients.
• Some medications should not be taken with elbasvir and grazoprevir or the dose of the medication or extra monitoring may need to occur while taking elbasvir and grazoprevir. Make sure you have discussed any medications you are currently taking or plan to take before starting elbasavir and grazoprevir with your doctor and pharmacist. Before starting, stopping or changing any medications while taking elbasavir and grazoprevir, please get the advice of your doctor or pharmacist.
• The following nonprescription or herbal products may interact with elbasvir and grazoprevir: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking elbasvir and grazoprevir. Do not start while taking elbasvir and grazoprevir without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had any type of liver disease other than hepatitis C. Your doctor may tell you not to take elbasvir and grazoprevir.
• tell your doctor if you have had or are waiting for a liver transplant or if you have human immunodeficiency virus (HIV).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking elbasvir and grazoprevir, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Elbasvir and grazoprevir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those in the IMPORTANT WARNING section, call your doctor immediately:

• sleepiness
• confusion
• swelling of stomach area
• vomiting blood or material that looks like coffee grounds
• dark, black, or bloody stools

Elbasvir and grazoprevir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Zepatier^®