Agalsidase beta

The effect of agalsidase beta treatment on the kidneys may be limited in patients with advanced renal disease.

Agalsidase beta should not be co-administered with amiodarone since this substance has the potential to inhibit intra-cellular b-galactosidase activity.

Agalsidase alfa should not be co-administered with gentamicin since this substance has the potential to inhibit intra-cellular α-galactosidase activity.

A small number of patients have experienced reactions suggestive of immediate (Type I) hypersensitivity. If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of agalsidase beta should be considered and appropriate treatment initiated. The current medical standards for emergency treatment are to be observed. With careful rechallenge agalsidase beta has been re-administered to all 6 patients who tested positive for IgE antibodies or had a positive skin test to agalsidase beta in a clinical trial. In this trial, the initial rechallenge administration was at a low dose and a lower infusion rate (½ the therapeutic dose at 1/25 the initial standard recommended rate). Once a patient tolerates the infusion, the dose may be increased to reach the therapeutic dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards, as tolerated.

There are no adequate data from the use of agalsidase beta in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development. Agalsidase beta should not be used during pregnancy unless clearly necessary.

Agalsidase beta may be excreted in milk. Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when agalsidase beta is used.

Fertility

Studies have not been conducted to assess the potential effects of agalsidase beta on impairment of fertility.

Agalsidase beta may have a minor influence on the ability to drive or use machines on the day of agalsidase beta administration because dizziness, somnolence, vertigo and syncope may occur.