Alglucosidase alfa Side Effects

Brand Names: Myozyme

Please note - some side effects for Alglucosidase alfa 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 Alglucosidase alfa - for the Consumer

Alglucosidase Alfa

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 Alglucosidase Alfa:

Constipation; diarrhea; heartburn; runny nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation, irritability, or restlessness; blue skin or nails; chest pain or tightness; chills; cold hands or feet; ear pain; excessive or cold sweat; fast, slow, or irregular heartbeat; feeling hot; fever; flushing; headache; increased tear production; nausea; pain, swelling, or redness at the injection site; pale skin; purplish skin discoloration; rapid or difficult breathing; severe headache or dizziness; stomach pain; swelling of the hands, legs, or feet; throat tightness; tremor; unexplained cough; unusual tiredness or weakness; vomiting; wheezing; white patches in the mouth.

Side Effects by Body System

Hypersensitivity

Hypersensitivity side effects have been reported including anaphylactic reactions.

Some reactions were life-threatening. One patient developed anaphylactic shock during alglucosidase alfa infusion that required life-support measures.

Other

Other side effects including infections and infestations (95%) have been reported. These have included pneumonia (46%), otitis media (44%), upper respiratory tract infection (44%), gastroenteritis (41%), pharyngitis (36%), ear Infection (33%), oral candidiasis (31%), catheter related infection (28%), bronchiolitis (23%), and nasopharyngitis (23%).

General

General side effects including pyrexia (92%) and post procedural pain (26%) have been reported.

Immunologic

Immunologic side effects including the presence of IgG antibodies to alglucosidase alfa (89%) have been reported.

The data reflect the percentage of patients whose test results were considered positive for antibodies to alglucosidase alfa. Most patients who developed antibodies did so within the first three months of exposure. There is evidence to suggest that patients developing sustained titers greater than or equal to 12,800 of anti-alglucosidase alfa antibodies may have a poorer clinical response to treatment, or may lose motor function as antibody titers increase.

Treated patients who experience a decrease in motor function should be tested for neutralization of enzyme uptake or activity. Five patients with antibody titers greater than or equal to 12,800 at week twelve had an average increase in clearance of 50% from week one to week twelve.

Infusion reactions were reported in twenty of thirty nine patients treated with alglucosidase alfa in clinical studies and appear to be more common in antibody-positive patients. Eight of fifteen patients with high antibody titers experienced infusion reactions whereas none of the three antibody-negative patients experienced infusion reactions.

Testing was performed for infusion reactions, especially moderate to severe or recurrent reactions, for which mast cell activation was suspected. Three of these patients tested positive for alglucosidase alfa specific IgE binding antibodies, one of whom experienced an anaphylactic reaction.

Gastrointestinal

Gastrointestinal side effects including diarrhea (62%), vomiting (49%), gastroesophageal reflux disease (26%), and constipation (23%) have been reported.

Dermatologic

Dermatologic side effects including rash (54%), diaper dermatitis (36%), urticaria (21%), angioneurotic edema, erythema, periorbital edema, pruritus, hyperhidrosis, cold sweats, and livedo reticularis have been reported.

Respiratory

Respiratory side effects have been reported including cough (46%), decreased oxygen saturation (41%), respiratory distress (33%), respiratory failure (31%), rhinorrhea (28%), tachypnea (23%), wheezing/bronchospasm, rales, throat tightness, hypoxia, dyspnea, and respiratory tract irritation.

Hematologic

Hematologic side effects including anemia (31%) have been reported.

Cardiovascular

Cardiovascular side effects including tachycardia (23%), bradycardia (21%), flushing (21%), hypotension, cyanosis, hypertension, ventricular extrasystoles, pallor, nodal rhythm, and peripheral coldness have been reported. Cardiac arrhythmia, including ventricular fibrillation, ventricular tachycardia, and bradycardia, resulting in cardiac arrest or death, or requiring cardiac resuscitation or defibrillation have been reported in infantile onset Pompe disease patients with cardiac hypertrophy (associated with the use of general anesthesia for the placement of a central venous catheter intended for alglucosidase alfa infusion).

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