In addition to the adverse reactions reported in Adverse Reactions in Clinical Studies (6.1) , the following adverse reactions have been reported during postmarketing use of agalsidase beta: arthralgia, asthenia, erythema, hyperhidrosis, infusion site reaction, lacrimation increased, leukocytoclastic vasculitis, lymphadenopathy, hypoesthesia, oral hypoesthesia, palpitations, rhinorrhea, oxygen saturation decreased, and hypoxia.

No drug interaction studies were performed.

No in vitro metabolism studies were performed.

There is no known interference by Fabrazyme with laboratory tests.  Antibody samples should be collected prior to Fabrazyme infusions.

Pregnancy Category B -

There are no adequate and well-controlled studies of Fabrazyme use in pregnant women. Reproduction studies performed in rats at doses up to 30 times the human dose have revealed no evidence of impaired fertility or negative effects on embryo fetal development due to Fabrazyme.  Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Women of childbearing potential should be encouraged to enroll in the Fabry patient registry. The registry will monitor the effect of Fabrazyme on pregnant women and their offspring.  For more information, visit  www.fabryregistry.com or call (800) 745-4447 [see Patient Counseling Information (17) ].

There is no information on the effect of Fabrazyme during labor and delivery. Pregnant females are encouraged to enroll in the Fabry registry [see Patient Counseling Information (17) ].

It is not known whether Fabrazyme is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fabrazyme is administered to a nursing woman.

Nursing mothers should be encouraged to enroll in the Fabry registry [see Use in Specific Populations (8.1) and Patient Counseling Information (17) ].

The safety and efficacy of Fabrazyme were assessed in a multi-national, multi-center, uncontrolled, open-label study in 16 pediatric patients with Fabry disease (14 males, 2 females), ages 8 to 16 years [see Clinical Studies (14) ].   Patients younger than 8 years of age were not included in clinical studies.  The safety and efficacy in patients younger than 8 years of age have not been eva luated.

Clinical studies of Fabrazyme did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Fabry disease is an X-linked genetic disorder. However, some heterozygous women will develop signs and symptoms of Fabry disease due to the variability of the X-chromosome inactivation within cells.

A total of 12 adult female patients with Fabry disease were enrolled in two separate randomized, double-blind, placebo-controlled clinical studies with Fabrazyme, and two female pediatric patients with Fabry disease, ages 11 years, were eva luated in an open-label, uncontrolled pediatric study [see Use in Specific Populations (8.4) and Clinical Studies (14) ].   Although the safety and efficacy data available in female patients in these clinical studies are limited, there is no indication that female patients respond differently to Fabrazyme compared to males.

There have been no reports of overdose with Fabrazyme. In clinical trials, patients received doses up to 3 m