Fabrazyme Side Effects

Generic name: agalsidase beta

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.

Some side effects of Fabrazyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to agalsidase beta: intravenous powder for injection

Symptoms of allergic or infusion reactions including difficulty breathing; closing of the throat; hives; rash; itching; fever; shaking; chest tightness; high or low blood pressure; fast heartbeats; muscle pain; stomach pain; nausea or vomiting; dizziness; numbness or tingling; and headache have occurred upon injection of agalsidase beta (the active ingredient contained in Fabrazyme) in many patients. Most patients treated with agalsidase beta develop antibodies to agalsidase beta and many will develop symptoms of an infusion reaction. A slow rate of injection of the medication and pretreatment with other medications may decrease the severity of these symptoms. Emergency medical attention may be required if a severe allergic reaction is experienced.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to agalsidase beta: intravenous powder for injection

General

In general, infusion-related side effects have been reported the most frequently. These have included tachycardia, hypertension, urticaria, chest pain, fever, and rigors. Temperature changed sensation and pallor have also been reported.

Cardiovascular

Cardiovascular side effects have included hypertension (greater than 10%), reports of cardiomegaly, hypotension, and edema.

Nervous system

Nervous system side effects including pain related to Fabry disease and headache have been reported in greater than 10% of patients. Cerebrovascular events (i.e., symptomatic stroke or transient ischemic attack) were reported in 9% of patients. Dizziness and paraesthesia have also been reported.

Gastrointestinal

Gastrointestinal side effects have included reports of dyspepsia and nausea.

Musculoskeletal

Musculoskeletal side effects have included reports of arthrosis and skeletal pain.

Psychiatric

Psychiatric side effects have included reports of anxiety and depression.

Respiratory

Respiratory side effects have included reports of bronchitis, bronchospasm, laryngitis, pharyngitis, rhinitis, and sinusitis.

Genitourinary

Genitourinary side effects reported by men involved in the placebo controlled study have included testicular pain.

Immunologic

Immunologic side effects have included reports of the development of antibodies to agalsidase beta (the active ingredient contained in Fabrazyme) Most patients involved in clinical studies developed antibodies within the first 3 months of exposure.

The reported rates of IgG seroconversion during the clinical studies were 88 % and 89 %. There are reports of decrease in titers after 12 months of treatment and one case that became seronegative. Seroconversion did not affect the efficacy end points. The clinical significance of the antibodies to agalsidase beta is not yet known.

Other

Other side effects including chills have been reported in greater than 10% of patients.

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