Agalsidase beta Side Effects

Brand Names: Fabrazyme

Please note - some side effects for Agalsidase beta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Agalsidase beta - for the Consumer

Agalsidase Beta

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Agalsidase Beta:

Dizziness; headache; nausea; runny or stuffy nose; sore throat; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain or tightness; chills; confusion; decreased hearing or hearing loss; decreased or painful urination; fainting; fast, slow, or irregular heartbeat; fever; joint pain; loss of coordination; mental or mood changes (eg, anxiety, depression); muscle pain or weakness; numbness or pain of an arm or leg; one-sided weakness; severe headache, dizziness, or nausea; shortness of breath; slurred speech; stomach pain; sudden vision changes; swelling (eg, hands, legs, feet, lips, ears); throat tightness; unusual tiredness or weakness; unusually pale skin; vomiting.

Side Effects by Body System

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. 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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