Victrelis Side Effects
Generic name: boceprevir
Medically reviewed by Drugs.com. Last updated on Jan 4, 2024.
Note: This document contains side effect information about boceprevir. Some dosage forms listed on this page may not apply to the brand name Victrelis.
Applies to boceprevir: oral capsule.
Warning
Boceprevir must be used in combination with peginterferon alfa and ribavirin.
Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.
Certain other drugs may interact with boceprevir or should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.
Get emergency medical help if you have any of these signs of an allergic reaction while taking boceprevir (the active ingredient contained in Victrelis) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using boceprevir and call your doctor at once if you have:
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tired feeling, weakness, confusion;
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easy bruising or bleeding (nosebleed, bleeding gums);
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pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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fever, chills, body aches, flu symptoms, sores in your mouth and throat.
Common side effects may include:
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headache;
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altered sense of taste; or
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nausea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to boceprevir: oral capsule.
General
This drug must be administered in combination with peginterferon alfa and ribavirin. The manufacturer product 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 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.[Ref]
Hematologic
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.
Agranulocytosis, pancytopenia, and thrombocytopenia have also been reported during postmarketing experience.[Ref]
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, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis
Uncommon (0.1% to 1%): Hemorrhagic diathesis, lymphadenopathy, lymphopenia
Rare (0.01% to 0.1%): Hemolysis[Ref]
Hypersensitivity
Frequency not reported: Serious acute hypersensitivity reactions (e.g., urticaria, angioedema)[Ref]
Other
Very common (10% or more): Fatigue (up to 58%), chills (up to 34%), pyrexia (up to 32%), influenza-like illness (up to 23%), asthenia (up to 21%), decreased weight (11%)
Common (1% to 10%): Pain, peripheral edema, chest discomfort, chest pain, malaise, feeling of body temperature change, mucosal dryness
Uncommon (0.1% to 1%): Feeling abnormal, impaired healing, noncardiac chest pain, staphylococcal infection, candidiasis, ear infection, ear discomfort, flushing, pallor, peripheral coldness
Rare (0.01% to 0.1%): Otitis media, sepsis
Sepsis has also been reported during postmarketing experience.
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%)
Common (1% to 10%): Abdominal pain, upper abdominal pain, constipation, gastroesophageal reflux disease, hemorrhoids, abdominal discomfort, abdominal distention, anorectal discomfort, aphthous stomatitis, cheilitis, dyspepsia, flatulence, glossodynia, mouth ulceration, oral pain, stomatitis, tooth disorder, oral fungal infection
Uncommon (0.1% to 1%): Lower abdominal pain, gastritis, pancreatitis, anal pruritus, colitis, dysphagia, discolored feces, frequent bowl movements, gingival bleeding, gingival pain, gingivitis, glossitis, dry lip, odynophagia, proctalgia, rectal hemorrhage, salivary hypersecretion, sensitivity of teeth, tongue discoloration, tongue ulceration, gastroenteritis
Rare (0.01% to 0.1%): Pancreatic insufficiency[Ref]
Mouth ulceration and stomatitis have also been reported during postmarketing experience.[Ref]
Nervous system
Very common (10% or more): Headache (up to 45%), dizziness (up to 19%)
Common (1% to 10%): Hypoesthesia, paresthesia, syncope, amnesia, attention disturbance, memory impairment, migraine, parosmia, tremor, vertigo, tinnitus
Uncommon (0.1% to 1%): Peripheral neuropathy, cognitive disorder, hyperesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope, deafness, impaired hearing
Rare (0.01% to 0.1%): Cerebral ischemia, encephalopathy[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 34%), irritability (up to 22%), depression (up to 21%), anxiety (12%)
Common (1% to 10%): Affect lability, agitation, libido disorder, altered mood, sleep disorder
Uncommon (0.1% to 1%): Aggression, homicidal ideation, panic attack, paranoia, substance abuse, suicidal ideation, abnormal behavior, anger, apathy, confusional state, mental status changes, restlessness
Rare (0.01% to 0.1%): Bipolar disorder, completed suicide, suicide attempt, auditory hallucination, visual hallucination, psychiatric decompensation[Ref]
Dermatologic
Very common (10% or more): Alopecia (up to 27%), dry skin (up to 22%), rash (up to 17%)
Common (1% to 10%): Dermatitis, eczema, erythema, hyperhidrosis, night sweats, psoriasis, erythematous rash, macular rash, maculopapular rash, papular rash, pruritic rash, skin lesion, cellulitis, herpes simplex
Uncommon (0.1% to 1%): Photosensitivity reaction, skin ulcer, urticaria, fungal skin infection, onychomycosis, skin infection
Postmarketing reports: Angioedema, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, exfoliative rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic skin eruption, toxicoderma[Ref]
Urticaria has also been reported during postmarketing experience.[Ref]
Metabolic
Very common (10% or more): Decreased appetite/anorexia (up to 26%)
Common (1% to 10%): Dehydration, hyperglycemia, hypertriglyceridemia, hyperuricemia
Uncommon (0.1% to 1%): Hypokalemia, appetite disorder, diabetes mellitus, gout, hypercalcemia
Rare (0.01% to 0.1%): Non-acute porphyria
Frequency not reported: Increased uric acid, increased triglycerides, increased cholesterol[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (up to 24%), arthralgia (up to 23%)
Common (1% to 10%): Back pain, pain in extremity, muscle spasms, muscular weakness, neck pain
Uncommon (0.1% to 1%): Musculoskeletal chest pain, arthritis, bone pain, joint swelling, musculoskeletal pain[Ref]
Respiratory
Pneumonia has also been reported during postmarketing experience.[Ref]
Very common (10% or more): Exertional dyspnea (up to 11%), cough, dyspnea
Common (1% to 10%): Bronchitis, influenza, sinusitis, epistaxis, nasal congestion, oropharyngeal pain, respiratory tract congestion, sinus congestion, wheezing
Uncommon (0.1% to 1%): Pneumonia, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, pleuritic pain, pulmonary embolism, dry throat, dysphonia, increased upper airway secretion, oropharyngeal blistering
Rare (0.01% to 0.1%): Epiglottitis, pleural fibrosis, orthopnea, respiratory failure[Ref]
Cardiovascular
Common (1% to 10%): Palpitations, hypotension, hypertension
Uncommon (0.1% to 1%): Cardiac murmur, increased heart rate, tachycardia, arrhythmia, cardiovascular disorder, deep vein thrombosis
Rare (0.01% to 0.1%): Acute myocardial infarction, atrial fibrillation, coronary artery disease, pericarditis, pericardial effusion, venous thrombosis
Endocrine
Common (1% to 10%): Goiter, hypothyroidism
Uncommon (0.1% to 1%): Hyperthyroidism
Genitourinary
Common (1% to 10%): Pollakiuria, erectile dysfunction
Uncommon (0.1% to 1%): Urinary tract infection, dysuria, nocturia, amenorrhea, menorrhagia, metrorrhagia
Rare (0.01% to 0.1%): Aspermia
Ocular
Common (1% to 10%): Dry eye, retinal exudates, blurred vision, visual impairment
Uncommon (0.1% to 1%): Retinal ischemia, retinopathy, abnormal sensation in eye, conjunctival hemorrhage, conjunctivitis, eye pain, eye pruritus, eye swelling, eyelid edema, increased lacrimation, ocular hyperemia, photophobia
Rare (0.01% to 0.1%): Papilledema
Hepatic
Uncommon (0.1% to 1%): Hyperbilirubinemia
Rare (0.01% to 0.1%): Cholecystitis
Immunologic
Rare (0.01% to 0.1%): Sarcoidosis
Oncologic
Rare (0.01% to 0.1%): Thyroid neoplasm (nodules)
Renal
Frequency not reported: Renal impairment, GFR decreased
Frequently asked questions
More about Victrelis (boceprevir)
- Check interactions
- Compare alternatives
- Reviews (3)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: protease inhibitors
- Breastfeeding
Patient resources
Professional resources
Related treatment guides
References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. EMEA. European Medicines Agency. EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid 2007.
3. Cerner Multum, Inc. Australian Product Information.
4. Product Information. Victrelis (boceprevir). Schering-Plough Corporation. 2011.
5. Rowe IA, Mutimer DJ. Protease inhibitors for treatment of genotype 1 hepatitis C virus infection. BMJ. 2011;343:d6972.
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.