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Sofosbuvir / velpatasvir / voxilaprevir Side Effects

For the Consumer

Applies to sofosbuvir / velpatasvir / voxilaprevir: 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.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

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:

  • Feeling tired or weak.
  • Headache.
  • Loose stools (diarrhea).
  • Upset stomach.
  • Not able to sleep.

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 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 0.2% of patients.[Ref]

Nervous system

Very common (10% or more): Headache (up to 23%)[Ref]

Other

Very common (10% or more): Fatigue (up to 19%)
Common (1% to 10%): Asthenia[Ref]

Gastrointestinal

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

Very common (10% or more): Diarrhea (up to 14%), nausea (up to 13%)
Common (1% to 10%): Elevated lipase[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.[Ref]

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

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depressed mood[Ref]

Cardiovascular

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

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

Dermatologic

Common (1% to 10%): Rash
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]

Musculoskeletal

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

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

References

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

Some side effects of sofosbuvir / velpatasvir / voxilaprevir 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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