Antibody Monitoring

Antibody monitoring is a service provided by the Genzyme immunosurveillance program. The primary objective of the alglucosidase alfa antibody monitoring service is to better understand and characterize the immune response within the Pompe patient population receiving ERT. Physicians who utilize this service benefit by receiving important antibody results for managing the care of their patients who are receiving alglucosidase alfa.

Please see full prescribing information for details regarding patients who developed anti-rhGAA antibodies while being treated with alglucosidase alfa.

IgG Antibodies

Regular monitoring of IgG antibody levels is recommended for all patients receiving alglucosidase alfa therapy. Genzyme recommends IgG antibody monitoring at baseline and every 3 months. Antibody development does not preclude continued treatment with alglucosidase alfa.

IgG Inhibitory Antibody Testing

Pompe disease treating physicians who observe a possible decrease in response and who suspect antibody formation playing a role will be advised to submit a blood sample for antibody testing through the Pharmacovigilance Department.

IgE, Complement & Serum Tryptase

IgE antibody, complement activation and/or serum tryptase testing may be warranted for patients who experience a moderate or severe or recurrent IAR suspected to represent a hypersensitivity reaction in patients treated with alglucosidase alfa. Samples for complement activation and serum tryptase testing should be drawn within 1-2 hours after the onset of the reaction. Samples for IgE testing should be drawn no sooner than 3 days following the onset of the reaction. The actual processing of samples for IgE, complement activation and/or serum tryptase testing is to be coordinated through Genzyme’s Pharmacovigilance Department.

Antibody Sample Collection Boxes/Collection Instructions/Results

Physicians should contact their local Genzyme representative for the antibody blood sample collection box and shipment procedure for their country.

Obtaining Antibody Results

IgG antibody test results will be reported by mail as soon as they are available, generally within 6 to 8 weeks. Results from infusion-associated reactions (IAR) labs will be expedited and will be made available prior to the patient’s next infusion.

Any questions regarding the assay tests or results of the testing should be directed to:

United States and All Other Countries (excluding Europe)

Genzyme Corporation
Medical Information Department
Cambridge, Massachusetts USA
Telephone:
Within US: 800-745-4447, option 2
Outside US: +1-617-768-9000, option 2

Genzyme Europe BV

Medical Services Department
Gooimeer 10
1411 DD Naarden
The Netherlands
Tel.: + 31-35-699-1431
Fax.: + 31-35-694-8756
E-mail: samples@genzyme.com