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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

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

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 (less than 0.1%): Hemolysis[Ref]

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]

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 (less than 0.1%): Otitis media, sepsis[Ref]

Sepsis has also been reported during postmarketing experience.[Ref]

Gastrointestinal

Mouth ulceration and stomatitis have also been reported during postmarketing experience.[Ref]

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 (less than 0.1%): Pancreatic insufficiency[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 (less than 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 (less than 0.1%): Bipolar disorder, completed suicide, suicide attempt, auditory hallucination, visual hallucination, psychiatric decompensation[Ref]

Dermatologic

Urticaria has also been reported during postmarketing experience.[Ref]

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]

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 (less than 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 (less than 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 (less than 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 (less than 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 (less than 0.1%): Papilledema

Hepatic

Uncommon (0.1% to 1%): Hyperbilirubinemia
Rare (less than 0.1%): Cholecystitis

Immunologic

Rare (less than 0.1%): Sarcoidosis

Oncologic

Rare (less than 0.1%): Thyroid neoplasm (nodules)

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Telaprevir (Incivek) and boceprevir (Victrelis) for chronic hepatitis C." Med Lett Drugs Ther 53 (2011): 57-9

4. "Product Information. Victrelis (boceprevir)." Schering-Plough Corporation, Kenilworth, NJ.

5. Chang MH, Gordon LA, Fung HB "Boceprevir: a protease inhibitor for the treatment of hepatitis C." Clin Ther 34 (2012): 2021-38

6. Rowe IA, Mutimer DJ "Protease inhibitors for treatment of genotype 1 hepatitis C virus infection." BMJ 343 (2011): d6972

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