Victrelis Side Effects

Generic Name: boceprevir

Note: This page contains side effects data for the generic drug boceprevir. It is possible that some of the dosage forms included below may not apply to the brand name Victrelis.

It is possible that some side effects of Victrelis may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to boceprevir: oral capsule

As well as its needed effects, boceprevir (the active ingredient contained in Victrelis) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking boceprevir, check with your doctor immediately:

More common
  • Black, tarry stools
  • chills
  • cough
  • difficult or labored breathing
  • fever
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • sore throat
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some boceprevir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Change in taste
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • dizziness
  • dry mouth
  • dry skin
  • hair loss or thinning of the hair
  • irritability
  • lack or loss of strength
  • loss of taste
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • rash
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • vomiting

For Healthcare Professionals

Applies to boceprevir: oral capsule

General

Boceprevir must be administered in combination with peginterferon alfa and ribavirin. The prescribing information for peginterferon alfa and ribavirin should be consulted for associated side effects.

Serious side effects (including anemia and neutropenia) have been reported in 11% of patients receiving boceprevir (the active ingredient contained in Victrelis) combination therapy compared to 8% of patients receiving peginterferon alfa plus ribavirin alone. The side effects reported most frequently (greater than 35%, regardless of causality) were fatigue, anemia, nausea, headache, and dysgeusia. Therapy was discontinued due to side effects in 13% of patients using boceprevir combination therapy and 12% of patients using peginterferon alfa plus ribavirin alone. The side effects leading to discontinuation most often were anemia and fatigue.

Most of the following side effects were reported in patients receiving boceprevir combination therapy with an incidence at least 5% greater than those receiving peginterferon alfa plus ribavirin alone.

Hematologic

Very common (10% or more): Anemia (up to 50%), decreased hemoglobin (up to 49%), decreased neutrophils (up to 31%), neutropenia (up to 25%)
Common (1% to 10%): Decreased platelets
Postmarketing reports: Agranulocytosis, pancytopenia, thrombocytopenia

Decreased hemoglobin (less than 10 g/dL: 49%; less than 8.5 g/dL: up to 10%), decreased neutrophils (less than 0.75 x 10[9]/L: up to 31%; less than 0.5 x 10[9]/L: up to 8%), and decreased platelets (less than 50 x 10[9]/L: up to 4%; less than 25 x 10[9]/L: less than 1%) have been reported.

Hypersensitivity

Frequency not reported: Serious acute hypersensitivity reactions (e.g., urticaria, angioedema)

Other

Very common (10% or more): Fatigue (up to 58%), chills (up to 34%), asthenia (up to 21%)
Frequency not reported: Pyrexia
Postmarketing reports: Sepsis

Gastrointestinal

Very common (10% or more): Nausea (up to 46%), dysgeusia (up to 44%), diarrhea (up to 25%), vomiting (up to 20%), dry mouth (up to 15%)
Postmarketing reports: Mouth ulceration, stomatitis

Psychiatric

Very common (10% or more): Insomnia (up to 34%), irritability (up to 22%)

Dermatologic

Very common (10% or more): Alopecia (up to 27%), dry skin (up to 22%), rash (up to 17%)
Postmarketing reports: Angioedema, urticaria, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma

Metabolic

Very common (10% or more): Decreased appetite/anorexia (up to 26%)

Musculoskeletal

Very common (10% or more): Arthralgia (up to 23%)

Nervous system

Very common (10% or more): Dizziness (up to 19%)
Frequency not reported: Headache

Respiratory

Very common (10% or more): Exertional dyspnea (up to 11%)
Postmarketing reports: Pneumonia

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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