Note: This document contains side effect information about agalsidase beta. Some dosage forms listed on this page may not apply to the brand name Fabrazyme.

Applies to agalsidase beta: intravenous powder for solution.

Serious side effects of Fabrazyme

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 or nurse immediately if any of the following side effects occur while taking agalsidase beta:

More common

• Blurred vision
• chest pain, discomfort, or tightness
• confusion
• cough producing mucus
• difficulty breathing
• difficulty in moving
• dizziness
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• feeling unusually cold shivering
• headache
• hives or welts, itching, skin rash
• irregular heartbeat
• joint pain
• muscle ache, cramps, pains, or stiffness
• nervousness
• pounding in the ears
• redness of the skin
• stomach pain
• sweating
• swelling of the ankles, feet, and lower legs
• swollen joints
• unusual tiredness or weakness

Incidence unknown

• Blue lips, fingernails, or skin
• chills
• cloudy or bloody urine
• cough
• decreased cardiac output
• decreased frequency or amount of urine
• difficulty in speaking
• difficulty swallowing
• dilated neck veins
• double vision
• feeling of constant movement of self or surroundings
• fever
• high blood pressure
• inability to move the arms, legs, or facial muscles
• increased thirst
• irregular, fast, or slow, or shallow breathing
• lack or loss of strength
• loss of appetite
• lower back or side pain
• nausea
• no breathing
• no pulse or blood pressure
• noisy breathing
• pain in the joints
• pain or discomfort in the arms, jaw, back, or neck
• problems with muscle control or coordination
• seizures
• sensation of spinning
• severe or sudden headache
• shakiness and unsteady walk
• slow or slurred speech
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• temporary blindness
• throat tightness
• trembling
• trouble breathing
• unconsciousness
• vomiting
• weakness in the arm and/or leg on one side of the body, sudden and severe
• weight gain

Other side effects of Fabrazyme

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:

More Common

• Acid or sour stomach
• belching
• body aches or pain
• body produces substance that can bind to drug making it less effective or cause side effects
• burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
• congestion
• discouragement
• dryness or soreness of the throat
• fear
• feeling sad or empty
• fever, not related to infusion
• heartburn
• hoarseness
• indigestion
• irritability
• loss of interest or pleasure
• pain or tenderness around eyes and cheekbones
• paleness of skin
• runny nose
• sensation of change in temperature
• skeletal pain
• sneezing
• stuffy nose
• trouble concentrating
• trouble sleeping
• voice changes

For Healthcare Professionals

Applies to agalsidase beta: intravenous powder for injection.

General

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.^[Ref]

Cardiovascular

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^[Ref]

Hypersensitivity

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

Gastrointestinal

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^[Ref]

Dermatologic

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^[Ref]

Immunologic

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.^[Ref]

Very common (10% or more): Anti-drug IgG antibody development (74%)

Postmarketing reports: Sepsis^[Ref]

Nervous system

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^[Ref]

Musculoskeletal

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^[Ref]

Other

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^[Ref]

Respiratory

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^[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression

Frequency not reported: Agitation, confessional state, visual hallucination, flat affect, restlessness^[Ref]

Metabolic

Frequency not reported: Hypocalcemia^[Ref]

Ocular

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^[Ref]

Renal

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^[Ref]

Local

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.^[Ref]

Frequency not reported: Catheter site rash, catheter site related reaction, infusion site pain, infusion site thrombosis

Postmarketing reports: Infusion site reactions^[Ref]

Hepatic

Frequency not reported: Alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased^[Ref]

Hematologic

Frequency not reported: Anemia, eosinophilia, leukopenia, hematocrit decreased, hemoglobin decreased

Postmarketing reports: Lymphadenopathy^[Ref]

Genitourinary

Frequency not reported: Prostate examination abnormal, albuminuria, proteinuria, dysuria, hematuria, benign prostatic hyperplasia, dysmenorrhea, nipple pain, erectile dysfunction^[Ref]