Glecaprevir and Pibrentasvir

IMPORTANT WARNING:

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 glecaprevir and pibrentasvir 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 glecaprevir and pibrentasvir. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea, 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 glecaprevir and pibrentasvir.

Talk to your doctor about the risks of taking glecaprevir and pibrentasvir.

WHY is this medicine prescribed?

The combination of glecaprevir and pibrentasvir is used to treat certain types of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults and children 3 years of age and older. It is also used to treat certain types of chronic hepatitis C infection in adults and children 3 years of age and older who have already received another medication to treat their hepatitis C infection. Glecaprevir is in a class of medications called HCV NS3/4A protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Pibrentasvir is in a class of medications called HCV NS5A inhibitors. It works by stopping the virus that causes hepatitis C to spread inside the body.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

The combination of glecaprevir and pibrentasvir comes as a tablet or pellets to take by mouth. It is usually taken with food once daily for 8 to 16 weeks. Your doctor will tell you how many tablets or packets of pellets to take for each dose. Take glecaprevir and pibrentasvir 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 glecaprevir and pibrentasvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Glecaprevir and pibrentasvir pellets should be taken with soft foods without chewing. To prepare a dose of glecaprevir and pibrentasvir pellets with soft food, sprinkle the entire contents of packets of pellets in a bowl or cup on a small amount of soft food such as peanut butter, chocolate hazelnut spread, cream cheese, jam, or Greek yogurt. Do not mix the pellets with liquid or foods that may slide off the spoon to prevent the medicine from dissolving too fast. Give the entire mixture within 15 minutes of sprinkling the pellets on food. If pellets stick to the bowl or cup, add a small amount of soft food and swallow the rest of the mixture. To avoid a bitter aftertaste, the pellets should not be chewed or dissolved in the food.

Continue to take glecaprevir and pibrentasvir even if you feel well. The length of your treatment depends on your condition, if you have previously taken certain HCV medications, how well you respond to the medication, and whether you experience serious side effects. Do not stop taking glecaprevir and pibrentasvir without talking to your doctor.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking glecaprevir and pibrentasvir,

• tell your doctor and pharmacist if you are allergic to glecaprevir, pibrentasvir, any other medications, or any of the ingredients in the glecaprevir and pibrentasvir tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking atazanavir (Reyataz^®, in Evotaz^®) or rifampin (Rifadin^®, Rimactan^®, in Rifamate^®, in Rifater^®). Your doctor will probably tell you not to take glecaprevir and pibrentasvir if you are taking one of these medications.

• some medications should not be taken with glecaprevir and pibrentasvir. Other medications may cause dosing changes or extra monitoring when taken with glecaprevir and pibrentasvir. Make sure you have discussed any medications you are currently taking or plan to take before starting glecaprevir and pibrentasvir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking glecaprevir and pibrentasvir, please get the advice of your doctor or pharmacist.

• the following herbal product may interact with glecaprevir and pibrentasvir: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking glecaprevir and pibrentasvir. Do not start this medication while taking glecaprevir and pibrentasvir without discussing with your healthcare provider.

• tell your doctor if you have any type of liver disease other than hepatitis C. Your doctor may tell you not to take glecaprevir and pibrentasvir.

• tell your doctor if you have or have ever had human immunodeficiency virus (HIV) or diabetes, or if you have ever received a liver or kidney transplant.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking glecaprevir and pibrentasvir, call your doctor.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If it is 18 hours or less after you miss a dose of glecaprevir and pibrentasvir, take the missed dose with food as soon as you remember it. However, if it is more than 18 hours since the time you should have taken your dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• headache
• tiredness
• weakness
• nausea
• diarrhea
• itching

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

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

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).

What should I know about STORAGE and DISPOSAL of this medication?

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).

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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.