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.

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

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