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Agalsidase beta Side Effects

For the Consumer

Applies to agalsidase beta: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by agalsidase beta. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking agalsidase beta:

More common:
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • cough producing mucus
  • difficulty breathing
  • difficulty in moving
  • dizziness;
  • fatigue
  • faintness or lightheadedness when getting up from a lying or sitting position suddenly
  • feeling unusually cold shivering
  • headache
  • hives or welts
  • irregular heartbeat
  • itching
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nervousness
  • pain
  • pounding in the ears
  • redness of skin
  • shortness of breath
  • skin rash
  • stomach pain
  • sweating
  • swelling of ankles, feet, and lower legs
  • swollen joints
  • tightness in chest
  • unusual tiredness or weakness
  • wheezing
Incidence unknown
  • Cloudy or bloody urine
  • decreased cardiac output
  • difficulty in speaking
  • double vision
  • feeling of constant movement of self or surroundings
  • high blood pressure
  • inability to move arms, legs, or facial muscles
  • inability to speak
  • no blood pressure or pulse
  • partial loss of hearing
  • pounding or rapid pulse
  • problems with muscle control or coordination
  • sensation of spinning
  • shakiness and unsteady walk
  • slow speech
  • stopping of heart
  • swelling of face
  • swelling of the lip or ear
  • throat tightness
  • trembling
  • unconsciousness

Severity: Minor

Some of the side effects that can occur with agalsidase beta may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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 throat
  • fear
  • feeling sad or empty
  • fever, not related to infusion
  • heartburn
  • hoarseness
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nausea
  • pain or tenderness around eyes and cheekbones
  • paleness of skin
  • runny nose
  • sensation of change in temperature
  • skeletal pain
  • sneezing
  • stuffy nose; swelling of testes
  • tender, swollen glands in neck
  • trouble concentrating
  • trouble sleeping
  • trouble in swallowing
  • 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[Ref]

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[Ref]

Immunologic

During clinical trials, 95 of 121 adult patients and 11 of 16 pediatric patients developed antidrug IgG antibodies; the majority of patients developed antibodies within the first 3 months of exposure. In pediatric patients, IgG seroconversion in pediatric patients was attributed to prolonged half-life, which was likely due to the ability of antibodies to act as carriers for their antigens. The clinical significance of binding and/or inhibitory antibodies to this drug is unknown.

Testing for IgE antibodies occurred in about 60 patients during clinical trials who experienced moderate to severe infusion reactions or in whom mast cell activation was suspected. Of the 60 patients tested, 7 tested positive for antidrug IgE antibodies or had a positive skin test specific to this drug.[Ref]

Very common (10% or more): Antidrug IgG antibody development (74%)
Frequency not reported: Anaphylaxis/anaphylactoid reaction, seasonal allergy, skin test positive
Postmarketing reports: Anaphylactic shock[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[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[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: Infusion-related reaction, sepsis, edema[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[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[Ref]

Renal

Common (1% to 10%): Blood creatinine increased
Frequency not reported: Nephrotic syndrome, creatinine clearance decreased, cystatin C increased, renal failure, renal impairment[Ref]

Local

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

References

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

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

3. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.

Not all side effects for agalsidase beta may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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