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Mavyret Side Effects

Generic Name: glecaprevir / pibrentasvir

Note: This document contains side effect information about glecaprevir / pibrentasvir. Some of the dosage forms listed on this page may not apply to the brand name Mavyret.

For the Consumer

Applies to glecaprevir / pibrentasvir: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Upset stomach.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to glecaprevir / pibrentasvir: oral tablet

General

The most common side effects reported with this drug in hepatitis C virus (HCV)-infected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) were headache and fatigue. The most common side effects reported in HCV-infected patients with severe renal dysfunction were pruritus and fatigue.[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)
Rare (less than 0.1%): Transient ischemic attack[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 17%)[Ref]

Other

Very common (10% or more): Fatigue (up to 14%)
Common (1% to 10%): Asthenia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 12%)
Common (1% to 10%): Diarrhea[Ref]

Hepatic

Common (1% to 10%): Elevated total bilirubin
Uncommon (0.1% to 1%): Direct hyperbilirubinemia[Ref]

Elevated total bilirubin (at least 2 times the upper limit of normal) was reported in 3.5% of patients; such elevations were seen in 1.2% of patients across phase 2 and 3 trials and were related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism. Bilirubin elevations were asymptomatic, transient, and generally occurred early during therapy; these elevations were mainly indirect and not associated with ALT elevations. No jaundice was observed and total bilirubin levels decreased after completion of therapy.[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Mavyret (glecaprevir-pibrentasvir)." Abbott Pharmaceutical, Abbott Park, IL.

Some side effects of Mavyret may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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