Glecaprevir and pibrentasvir is a combination antiviral medicine used to treat chronic hepatitis C in people with HCV genotype 1, 2, 3, 4, 5, or 6.

Glecaprevir and pibrentasvir is usually given after other treatments have failed.

Glecaprevir and pibrentasvir may also be used for purposes not listed in this medication guide.

You should not use glecaprevir and pibrentasvir if you have severe liver disease, or if you also take atazanavir or rifampin.

If you've ever had hepatitis B, it may become active or get worse after you stop using glecaprevir and pibrentasvir. You may need frequent liver function tests for several months.

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.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using glecaprevir and pibrentasvir.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You should not stop using glecaprevir and pibrentasvir suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.

Use all hepatitis C medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using glecaprevir and pibrentasvir. You may need frequent liver function tests while using glecaprevir and pibrentasvir and for several months after your last dose.

Store this medicine in the original container at room temperature away from moisture and heat.

You should not use this medicine if you are allergic to glecaprevir or pibrentasvir, or if:

• you have liver disease; or

• you also take atazanavir or rifampin.

Tell your doctor if you have ever had:

• hepatitis B;

• liver problems other than hepatitis;

• a liver or kidney transplant;

• HIV (human immunodeficiency virus); or

• an opioid addiction or past use of injected drugs.

Tell your doctor if you are pregnant or breastfeeding.

Glecaprevir and pibrentasvir should not be given to a child younger than 3 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 18 hours late for the dose. Do not use two doses at one time.

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

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Using glecaprevir and pibrentasvir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. 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.

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, glecaprevir and pibrentasvir may cause serious liver injury. Tell your doctor right away if you have symptoms such as:

• right-sided upper stomach pain;

• nausea, vomiting, loss of appetite;

• confusion, tiredness, feeling light-headed;

• easy bruising or bleeding, vomiting blood;

• diarrhea, black or bloody stools;

• dark urine; or

• yellowing of your skin or eyes.

Common side effects of glecaprevir and pibrentasvir may include:

• headache; or

• tiredness.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs can affect glecaprevir and pibrentasvir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.