Canada - English - Health Canada

alexion pharma gmbh - asfotase alfa - solution - 40mg - asfotase alfa 40mg - enzymes

Canada - English - Health Canada

alexion pharma gmbh - asfotase alfa - solution - 40mg - asfotase alfa 40mg - enzymes

Canada - English - Health Canada

alexion pharma gmbh - asfotase alfa - solution - 40mg - asfotase alfa 40mg - enzymes

Canada - English - Health Canada

alexion pharma gmbh - asfotase alfa - solution - 100mg - asfotase alfa 100mg - enzymes

Canada - English - Health Canada

alexion pharma gmbh - ravulizumab - solution - 10mg - ravulizumab 10mg - immunosuppressive agents

Canada - English - Health Canada

alexion pharma gmbh - ravulizumab - solution - 300mg - ravulizumab 300mg

Canada - English - Health Canada

alexion pharma gmbh - ravulizumab - solution - 1100mg - ravulizumab 1100mg

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

alexion pharmaceuticals, inc. - sebelipase alfa (unii: k4ytu42t8g) (sebelipase alfa - unii:k4ytu42t8g) - sebelipase alfa 2 mg in 1 ml - kanuma® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase (lal) deficiency. none. risk summary available data with kanuma use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. animal reproductive studies conducted with sebelipase alfa showed no evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at dosages up to 164 and 526 times the human dosage of 1 mg/kg every other week (based on auc) in rats and rabbits, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. animal data sebelipase alfa administered during the period of organogenesis to rats (on gestation days 6, 9, 12, 15 and 17) and rabbits

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

alexion pharmaceuticals, inc. - asfotase alfa (unii: z633861eim) (asfotase alfa - unii:z633861eim) - asfotase alfa 18 mg in 0.45 ml - strensiq® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (hpp). none. risk summary there are no available data on strensiq use in pregnant women to inform a drug associated risk. in animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose (see data) . 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 animal data asfotase alfa administered during the period of organogenesis to rats (from gestation day 6 to day 19 post-partum) and rabbits (on gestation days 7 to 19) at intravenous doses up to 50 mg/kg/day, approximately 21 and 24 times the human auc of 65486 ng.h/ml

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

alexion pharmaceuticals, inc. - andexanet alfa (unii: bi009e452r) (andexanet alfa - unii:bi009e452r) - andexxa is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. this indication is approved under accelerated approval based on the change from baseline in anti-fxa activity in healthy volunteers [see clinical studies (14)] . an improvement in hemostasis has not been established. continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. limitations of use andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any fxa inhibitors other than apixaban or rivaroxaban. none. risk summary there are no adequate and well-controlled studies of andexxa in pregnant women to inform patients of associated risks. animal reproductive and developmental studies have not been conducted with andexxa. in the u.s. general population, the estimated background risk of major birth defects and