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Agalsidase Beta Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.

Applies to agalsidase beta: intravenous powder for solution.

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:

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

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:

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

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.

Gastrointestinal

Dermatologic

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]

Nervous system

Musculoskeletal

Other

Respiratory

Psychiatric

Metabolic

Ocular

Renal

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]

Hepatic

Hematologic

Genitourinary

References

1. (2003) "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation

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

3. Cerner Multum, Inc. "Australian Product Information."

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.

Some side effects may not be reported. You may report them to the FDA.