Note: This document contains side effect information about agalsidase beta. Some of the dosage forms listed on this page may not apply to the brand name Fabrazyme.
Applies to agalsidase beta: intravenous powder for solution
Along with its needed effects, agalsidase beta (the active ingredient contained in Fabrazyme) 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 agalsidase beta:
Some side effects of agalsidase beta 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:
Applies to agalsidase beta: intravenous powder for injection
The most serious adverse reactions were anaphylactic/anaphylactoid and allergic reactions.
The most frequently reported adverse reactions were infusion reactions and consisted of chills, fever, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, peripheral edema, back pain, pallor, bradycardia, hypotension, face edema, rash, and somnolence.
Very common (10% or more): Hypertension (14%)
Common (1% to 10%): Tachycardia, ventricular wall thickening, hot flush, palpitations, blood pressure increased, heart rate increased, blood pressure increased, flushing, pallor, bradycardia
Uncommon (0.1% to 1%): Sinus bradycardia, peripheral coldness
Frequency not reported: Cardiac arrhythmia, cardiac arrest, cardiac output decreased, aortic valve incompetence, supraventricular arrhythmia, right bundle branch block, cardiac valve disease, atrial dilation, ventricular dilation, mitral valve disease, mitral valve incompetence, mitral valve sclerosis, pulmonary valve incompetence, supraventricular extrasystoles, ventricular extrasystoles, ventricular hypokinesia, cardiac imaging procedure abnormal, ejection fraction decreased, ECG PR shortened, ECG ST segment abnormal, ECG T wave abnormal, heart rate irregular, right ventricular systolic pressure increased, orthostatic hypotension, poor peripheral circulation, poor venous access, vasoconstriction, vasospasm
Postmarketing reports: Cardiorespiratory arrest, cardiac failure, myocardial infarction, palpitations
In clinical trials, IgE antibody testing was performed in about 60 patients who experienced moderate to severe infusion reactions or in whom mast cell activation was suspected. Of the approximately 60 patients tested, 7 tested positive for anti-drug IgE antibodies or had a positive skin test.
Frequency not reported: Anaphylaxis/anaphylactoid reaction, seasonal allergy, skin test positive
Postmarketing reports: Anaphylactic shock
Very common (10% or more): Nausea, vomiting
Common (1% to 10%): Toothache, dry mouth, abdominal pain/discomfort, stomach discomfort, hypoesthesia oral, upper abdominal pain, diarrhea
Uncommon (0.1% to 1%): Dyspepsia, dysphagia
Frequency not reported: gastroenteritis, gingivitis, retching
Postmarketing reports: Lip swelling, tongue swelling
Very common (10% or more): Rash (20%), pruritus (10%)
Common (1% to 10%): Urticaria, erythema, angioneurotic edema, maculopapular rash
Uncommon (0.1% to 1%): Livedo reticularis, rash erythematosus, pruritic rash, skin discoloration, skin discomfort
Frequency not reported: Leukocytoclastic vasculitis, pustular rash, excoriation, acne, eczema, hair growth abnormal
Postmarketing reports: Hyperhidrosis, localized angioedema, erythema
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies described below with the incidence of antibodies in other studies or to other agalsidase products may be misleading. The following data reflect the percentage of patients whose test results were considered positive for antibodies to this drug using an ELISA and radioimmunoprecipitation assay for antibodies. During clinical trials, 95 of 121 adult patients and 11 of 16 pediatric patients developed anti-drug IgG antibodies; the majority of whom developed antibodies within the first 3 months. In pediatric patients, IgG seroconversion was associated with a prolonged half-life which was not seen in adults. This prolonged half-life may be due to the ability of antibodies to act as carriers for their antigens. Among the 14 females, 6 adult females developed IgG anti-drug antibodies.
Very common (10% or more): Anti-drug IgG antibody development (74%)
Postmarketing reports: Sepsis
Very common (10% or more): Headache (39%), paresthesia (31%), dizziness (21%)
Common (1% to 10%): Burning sensation, somnolence, hypoesthesia, lethargy, syncope
Uncommon (0.1% to 1%): Hyperesthesia, tremor
Frequency not reported: Stroke, ataxia, cerebrovascular accident, ischemic stroke, migraine, psychomotor hyperactivity, sinus headache, vasovagal syncope, restless leg syndrome, balance disorder, dyskinesia
Postmarketing reports: Cerebrovascular accident, hypesthesia, oral hypoesthesia
Very common (10% or more): Pain in extremity (19%), back pain (16%), myalgia (14%)
Common (1% to 10%): Muscle spasms, arthralgia, muscle tightness, musculoskeletal stiffness, musculoskeletal pain
Frequency not reported: Chest wall pain, flank pain, groin pain, joint stiffness, musculoskeletal chest pain, pain in jaw, shoulder pain
Postmarketing reports: Arthralgia
Very common (10% or more): Chills (43%), pyrexia (39%), procedural pain (25%), fatigue (24%), peripheral edema (21%), pain (16%), feeling cold (11%), adverse event (10%), post procedural complication (10%)
Common (1% to 10%): Tinnitus, hypoacusis, chest discomfort, fungal infection, viral infection, localized infection, fall, contusion, thermal burn, feeling hot, asthenia, chest pain, face edema, malaise, hyperthermia, body temperature increased, vertigo
Uncommon (0.1% to 1%): Auricular swelling, ear pain/discomfort, influenza-like illness
Frequency not reported: Oxygen saturation decreased, hypoacousia, axillary pain, discomfort, feeling jittery, gait disturbance, sluggishness, thirst, gingival infection, infection, tooth infection, fall, post procedural nausea, vascular access complication, blood alkaline phosphatase increased
Postmarketing reports: Asthenia
Very common (10% or more): Upper respiratory tract infection (44%), cough (33%), nasal congestion (19%), lower respiratory tract infection (18%)
Common (1% to 10%): Sinusitis, pharyngitis, dyspnea, exacerbated dyspnea, respiratory tract congestion, wheezing, throat tightness, nasopharyngitis
Uncommon (0.1% to 1%): Rhinitis, bronchospasm, pharyngolaryngeal pain, rhinorrhea, tachypnea, upper respiratory tract congestion
Frequency not reported: Hypoxia, pulmonary edema, respiratory distress, allergic rhinitis, rhonchi, throat irritation
Postmarketing reports: Respiratory failure, pneumonia, pharyngeal edema, rhinorrhea, hypoxia
Common (1% to 10%): Anxiety, depression
Frequency not reported: Agitation, confessional state, visual hallucination, flat affect, restlessness
Frequency not reported: Hypocalcemia
Common (1% to 10%): Lacrimation increased
Uncommon (0.1% to 1%): Eye pruritus, ocular hyperemia
Frequency not reported: Diplopia, eye edema, night blindness, blurred vision, visual acuity reduced, visual disturbance, intraocular pressure increased
Postmarketing reports: Eye swelling, increased lacrimation
Common (1% to 10%): Blood creatinine increased
Frequency not reported: Nephrotic syndrome, creatinine clearance decreased, cystatin C increased, renal failure, renal impairment
Postmarketing reports: Renal failure
Frequency not reported: Catheter site rash, catheter site related reaction, infusion site pain, infusion site thrombosis
Postmarketing reports: Infusion site reactions
Postmarketing infusion-associated reactions include anaphylaxis, localized angioedema (including auricular swelling, eye swelling, dysphagia, lip swelling, edema, pharyngeal edema, face swelling, and swollen tongue), and bronchospasm.
Frequency not reported: Alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased
Frequency not reported: Anemia, eosinophilia, leukopenia, hematocrit decreased, hemoglobin decreased
Postmarketing reports: Lymphadenopathy
Frequency not reported: Prostate examination abnormal, albuminuria, proteinuria, dysuria, hematuria, benign prostatic hyperplasia, dysmenorrhea, nipple pain, erectile dysfunction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Fabrazyme (www.drugs.com/fabrazyme.html).
March 28, 2020
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