Victrelis Side Effects
Generic Name: boceprevir
Note: This document contains side effect information about boceprevir. Some of the dosage forms listed on this page may not apply to the brand name Victrelis.
Some side effects of Victrelis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to boceprevir: oral capsule
Along with its needed effects, boceprevir (the active ingredient contained in Victrelis) 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 boceprevir:More common
- Black, tarry stools
- difficult or labored breathing
- lower back or side pain
- painful or difficult urination
- pale skin
- shortness of breath
- 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 side effects of boceprevir 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
- Change in taste
- decreased appetite
- difficulty with moving
- dry mouth
- dry skin
- hair loss or thinning of the hair
- lack or loss of strength
- loss of taste
- muscle pain or stiffness
- pain in the joints
- trouble sleeping
- unable to sleep
For Healthcare Professionals
Applies to boceprevir: oral capsule
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.
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/L: up to 31%; less than 0.5 x 10/L: up to 8%), and decreased platelets (less than 50 x 10/L: up to 4%; less than 25 x 10/L: less than 1%) have been reported.
Frequency not reported: Serious acute hypersensitivity reactions (e.g., urticaria, angioedema)
Very common (10% or more): Fatigue (up to 58%), chills (up to 34%), asthenia (up to 21%)
Frequency not reported: Pyrexia
Postmarketing reports: Sepsis
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
Very common (10% or more): Insomnia (up to 34%), irritability (up to 22%)
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
Very common (10% or more): Decreased appetite/anorexia (up to 26%)
Very common (10% or more): Arthralgia (up to 23%)
Very common (10% or more): Dizziness (up to 19%)
Frequency not reported: Headache
Very common (10% or more): Exertional dyspnea (up to 11%)
Postmarketing reports: Pneumonia
More about Victrelis (boceprevir)
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