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Vosevi Side Effects

Generic Name: sofosbuvir / velpatasvir / voxilaprevir

Note: This document contains side effect information about sofosbuvir / velpatasvir / voxilaprevir. Some of the dosage forms listed on this page may not apply to the brand name Vosevi.

For the Consumer

Applies to sofosbuvir/velpatasvir/voxilaprevir: oral tablet

Warning

Oral route (Tablet)

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir / velpatasvir / voxilaprevir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Side effects requiring immediate medical attention

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

Check with your doctor immediately if any of the following side effects occur while taking sofosbuvir / velpatasvir / voxilaprevir:

Incidence not known

  • Chest pain or discomfort
  • dark-colored urine
  • headache
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness, dizziness, or fainting
  • light-colored stools
  • skin rash, sometimes with blisters or hive-like swelling
  • slow or irregular heartbeat
  • stomach pain, continuing
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Side effects not requiring immediate medical attention

Some side effects of sofosbuvir / velpatasvir / voxilaprevir 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

Less common

  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • tiredness
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet

General

The most common side effects reported with this drug were headache, fatigue, diarrhea, and nausea. This drug was permanently discontinued due to side effects in up to 0.2% of patients.[Ref]

Nervous system

Very common (10% or more): Headache (up to 27%)[Ref]

Other

Very common (10% or more): Fatigue (up to 24%)

Common (1% to 10%): Asthenia[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%), nausea (up to 14%)

Common (1% to 10%): Elevated lipase, abdominal pain, vomiting[Ref]

Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in 2% of patients.[Ref]

Hepatic

Due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir, increased total bilirubin (up to 1.5 x ULN) occurred with this drug. No jaundice was observed and total bilirubin levels decreased after completion of therapy.

Cases of hepatic decompensation/failure (including fatal outcomes) have been reported during postmarketing experience in patients treated with hepatitis C virus nonstructural protein 3/4A (NS3/4A) protease inhibitor-containing regimens (including this drug). Reported cases occurred in patients with baseline cirrhosis with and without moderate or severe liver dysfunction (Child-Pugh B or C).[Ref]

Very common (10% or more): Increased total bilirubin (up to 13%)

Postmarketing reports: Hepatic decompensation, hepatic failure[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Depressed mood[Ref]

Cardiovascular

Sofosbuvir-containing regimens:

-Frequency not reported: Severe bradycardia, heart block

-Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]

Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with amiodarone and/or other agents that lower heart rate.

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir.[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Stevens-Johnson syndrome

Sofosbuvir-containing regimens:

-Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]

Musculoskeletal

Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 1% of patients.[Ref]

Common (1% to 10%): Back pain, myalgia

Uncommon (0.1% to 1%): Elevated creatine kinase, muscle spasm[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

References

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

2. "Product Information. Vosevi (sofosbuvir / velpatasvir / voxilaprevir)." Gilead Sciences, Foster City, CA.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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