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Glecaprevir / pibrentasvir Side Effects

For the Consumer

Applies to glecaprevir / pibrentasvir: oral tablet

Along with its needed effects, glecaprevir / pibrentasvir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of glecaprevir / pibrentasvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

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 glecaprevir / pibrentasvir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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