Mavyret 100 mg-40 mg tablet

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Medication name

Generic name:
Glecaprevir/pibrentasvir - oral

Pronunciation
(glek-A-pre-vir/pi-BRENT-as-vir)

Brand name(s)
Mavyret

Warning

Although this product helps many people with hepatitis C, it may rarely cause serious liver problems. Also, people who have another liver problem called hepatitis B may get worse. Before starting this product, tell your doctor if you have ever had hepatitis B or any other liver problems. See also Precautions section. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.

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 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.

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 your doctor has prescribed this product because he or she 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).

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. 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.

Storage

Store in the original package at room temperature away from light and moisture. 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.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised September 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.