United States - English - NLM (National Library of Medicine)

genzyme corporation - agalsidase beta (unii: rzd65tsm9u) (agalsidase beta - unii:rzd65tsm9u) - agalsidase beta 5 mg in 1 ml - fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed fabry disease. none. risk summary available data from a pregnancy sub-study within the fabry disease registry, post-marketing case reports, and case series with fabrazyme use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (see data). reproduction studies performed in rats at doses up to 68 times the human dose have revealed no evidence of effects on embryo-fetal development (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data from a pregnancy sub-study within the fabry disease registry, post-marketing case reports, and case series with fabrazyme use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in the fabry disease registry pregnancy sub-study, 33 pregnancies exposed to fabrazyme prior to or during pregnancy had a known outcome; 5 were reported as exposed in the first trimester. animal data the effects of agalsidase beta on embryo-fetal development in rats were evaluated at doses of 3, 10, and 30 mg/kg/day (up to 68 times the human dose of 1 mg/kg every 2 weeks on a body surface area basis) during gestation days 7 to 17. hepatocellular necrosis consistent with accumulation of test article was evident in maternal livers in the 10 and 30 mg/kg/day groups (23 and 68 times the human dose on a body surface area basis). there were no adverse effects of agalsidase beta on embryo-fetal development in rats. risk summary the available human data detected small amounts of agalsidase beta in human milk. available data from the clinical study, global pharmacovigilance database, and published scientific literature are insufficient to determine the effects of fabrazyme on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fabrazyme and any potential adverse effects on the breastfed child from fabrazyme or from the underlying maternal condition. the safety and effectiveness of fabrazyme have been established in pediatric patients based on adequate and well-controlled studies in adults, a single-arm, open-label study in 16 pediatric patients with fabry disease aged 8 to 16 years, and additional data in 24 patients with fabry disease aged 2 to 7 years [see clinical pharmacology (12.2) and clinical studies (14)] . the overall safety profile of fabrazyme was similar between the pediatric and the adult population [see adverse reactions (6.1) and clinical studies (14)] . clinical studies of fabrazyme did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Israel - English - Ministry of Health

sanofi israel ltd - agalsidase beta - powder for concentrate for solution for infusion - agalsidase beta 35 mg/vial - agalsidase beta - agalsidase beta - fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease. (alfa - galactosidase a deficiency).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

genzyme therapeutics ltd - agalsidase beta - powder for solution for infusion - 5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

genzyme therapeutics ltd - agalsidase beta - powder for solution for infusion - 35mg

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - agalsidase beta - injection, powder, for solution - 37.0mg/35mg vial - agalsidase beta 37.0mg/35mg vial

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - agalsidase beta - injection, powder, for solution - 5.5mg/5mg vial - agalsidase beta 5.5mg/5mg vial

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - agalsidase beta, quantity: 5.5 mg - injection, powder for - excipient ingredients: nitrogen; monobasic sodium phosphate monohydrate; mannitol; dibasic sodium phosphate heptahydrate - fabrazyme is indicated for the long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (alpha-galactosidase deficiency).

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - agalsidase beta, quantity: 35 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate; nitrogen; dibasic sodium phosphate heptahydrate; mannitol - fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (alpha-galactosidase deficiency).

European Union - English - EMA (European Medicines Agency)

sanofi b.v. - agalsidase beta - fabry disease - other alimentary tract and metabolism products, - fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (α-galactosidase-a deficiency).

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - agalsidase beta - powder for solution - 5mg - agalsidase beta 5mg - enzymes