Uses

This medication is a combination of glecaprevir and pibrentasvir and is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Glecaprevir and pibrentasvir work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis) or liver cancer.

It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once every day. In children, the dosage is based on weight.

If you are using the pellet form of this medication, first place about 1 to 2 teaspoons of soft food in a container. Use soft foods that will stick to a spoon (such as peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt). Do not use any foods that are solid, watery, heated, or frozen. Gently shake the packet, then tap to make sure the pellets fall to the bottom before opening. Cut open the packet(s) and pour the dose into the container of soft food. Gently mix and give all of the dose right away. The mixture should be taken within 15 minutes without chewing or crushing. Chewing, crushing, or waiting to give the dose may make this medication taste bitter and not work as well.

For the best effect, take glecaprevir/pibrentasvir at evenly spaced times. To help you remember, take this medication at the same time every day.

The length of treatment is based on your medical condition and other treatments you may have used before taking this medication. Continue to take this product for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.

Side Effects

See also Warning section.

Tiredness, headache, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this product has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to glecaprevir or pibrentasvir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• other liver problems (such as hepatitis B, liver cancer)
• overuse of or addiction to alcohol
• HIV infection
• diabetes

If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially vomiting.

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if the medications in this product pass into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain "statin" cholesterol drugs (such as atorvastatin, lovastatin, simvastatin), among others.

Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include cyclosporine, efavirenz, HIV protease inhibitors (such as atazanavir, darunavir), rifampin, certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), St. John's wort, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this product with others.

Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is 6 hours or less until the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original package at room temperature away from light and moisture. Do not open the packets until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.