Agalsidase Beta Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 25, 2024.

Applies to agalsidase beta: intravenous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, tightness in chest, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a fever, chills or shaking, chest pain, dizziness, flushing, headache, trouble breathing, hives, itching, or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or trouble breathing after receiving this medicine.

Serious side effects of agalsidase beta

Along with its needed effects, agalsidase beta 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:

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 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:

For healthcare professionals

Applies to agalsidase beta: intravenous powder for injection.

General adverse events

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

• Frequency not reported: Anaphylaxis/anaphylactoid reaction, seasonal allergy, skin test positive
• Postmarketing reports: Anaphylactic shock

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.

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

• Very common (10% or more): Anti-drug IgG antibody development (74%)
• Postmarketing reports: Sepsis^[Ref]

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]

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

• Frequency not reported: Catheter site rash, catheter site related reaction, infusion site pain, infusion site thrombosis
• Postmarketing reports: Infusion site reactions^[Ref]

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]

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]

See also:

Further information

Agalsidase beta side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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