Canada - English - Health Canada

biocryst pharmaceuticals inc - berotralstat (berotralstat hydrochloride) - capsule - 150mg - berotralstat (berotralstat hydrochloride) 150mg

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

biocryst pharmaceuticals inc. - berotralstat hydrochloride (unii: 88sh1nbl2b) (berotralstat - unii:xza0kb1bdq) - orladeyo® is indicated for prophylaxis to prevent attacks of hereditary angioedema (hae) in adults and pediatric patients 12 years of age and older. limitations of use : the safety and effectiveness of orladeyo for the treatment of acute hae attacks have not been established. orladeyo should not be used for treatment of acute hae attacks. additional doses or doses of orladeyo higher than 150 mg once daily are not recommended due to the potential for qt prolongation [see warnings and precautions (5.1)]. none risk summary there are insufficient data in pregnant women available to inform drug-related risks with orladeyo use in pregnancy. based on animal reproduction studies, no evidence of structural alterations was observed when berotralstat was administered orally to pregnant rats and rabbits during organogenesis at doses up to approximately 10 and 2 times, respectively, the maximum recommended human daily dose (mrhdd) in adults on an auc basis (see data) . 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 2-4% and 15-20%, respectively. data animal data in animal reproduction studies, oral administration of berotralstat to pregnant rats and rabbits during the period of organogenesis did not cause fetal structural alterations. the berotralstat dose in rats and rabbits was up to approximately 10 and 2 times, respectively, the mrhdd in adults (on an auc basis at maternal doses of 75 and 100 mg/kg/day, respectively). in a pre- and postnatal development study in rats, oral administration of berotralstat to pregnant rats during the period of organogenesis and until delivery at doses up to 45 mg/kg/day (approximately 2 times of the mrhdd on a mg/m2 basis) did not cause fetal structural alterations either. berotralstat concentrations in the fetal blood were approximately 5-11% of the maternal blood. risk summary there are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production. however, when a drug is present in animal milk, it is likely that the drug will be present in human milk. low levels of berotralstat were detected in the plasma of rat pups when dams were dosed with the drug orally during the lactation period. the berotralstat concentration in the pup plasma was approximately 2% of the maternal plasma (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for orladeyo and any potential adverse effects on the breastfed infant from orladeyo or from the underlying maternal condition. data animal data in the pre- and post-natal development study in rats, berotralstat was administered to dams during the pregnancy and lactation periods at doses up to 45 mg/kg/day (approximately 2 times of the mrhdd on a mg/m2 basis). berotralstat was detected in the plasma of pups during the lactation period. the berotralstat concentration in the pup plasma was approximately 2% of the maternal plasma. both dams and pups at 45 mg/kg/day showed statistically significant decreases in body weight gain (p<0.05). no treatment-related effects were observed at 25 mg/kg/day (approximately equal to the mrhdd on a mg/m2 basis). the safety and effectiveness of orladeyo for prophylaxis to prevent attacks of hereditary angioedema have been established in pediatric patients aged 12 and older. use of orladeyo in this population is supported by evidence from an adequate and well-controlled study (trial 1) that included adults and a total of 6 adolescent patients aged 12 to <18 years of age. the safety profile and attack rate on study were similar to those observed in adults [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . an additional 10 adolescent patients aged 12 to <18 years were enrolled in the open-label study (trial 2). the safety and effectiveness of orladeyo in pediatric patients <12 years of age have not been established. the safety and effectiveness of orladeyo were evaluated in a subgroup of patients (n=9) aged ≥65 years in trial 1. results of the subgroup analysis by age were consistent with overall study results. the safety profile from an additional 5 elderly patients aged ≥65 years enrolled in the open-label, long-term safety study (trial 2) was consistent with data from trial 1 [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . no dosage adjustment of orladeyo is recommended for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . orladeyo has not been studied in patients with end-stage renal disease (clcr <15 ml/min or egfr <15 ml/min/1.73 m2 or patients requiring hemodialysis), and therefore is not recommended for use in these patient populations [see clinical pharmacology (12.3)]. no dosage adjustment of orladeyo is recommended for patients with mild hepatic impairment (child-pugh class a) [see clinical pharmacology (12.3)] . in patients with moderate or severe hepatic impairment (child-pugh b or c), the recommended dose of orladeyo is 110 mg once daily with food [see dosage and administration (2.2) and clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

neopharm (israel)1996 ltd - berotralstat as dihydrochloride - capsules - berotralstat as dihydrochloride 110 mg - berotralstat - orladeyo is indicated for prophylaxis to prevent attacks of hereditary angioedema (hae) in adults and pediatric patients 12 years of age and older

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - berotralstat as dihydrochloride - capsules - berotralstat as dihydrochloride 150 mg - berotralstat - orladeyotm is indicated for prophylaxis to prevent attacks of hereditary angioedema (hae) in adults and pediatric patients 12 years of age and older.

European Union - English - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, hereditary - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

biocryst pharmaceuticals, inc, united states - berotralstat - capsule, hard - 150 mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

torii pharmaceutical co.,ltd - berotralstat hydrochloride - blue/white capsule, major axis: approx. 19 mm, no. 1 capsule

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

lexicon pharmaceuticals, inc. - telotristat ethyl (unii: 8g388563m7) (telotristat - unii:381v4fcv2z) - telotristat ethyl 250 mg - xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy. none. risk summary there are no human data with xermelo use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral telotristat ethyl to rats during organogenesis at doses up to 750 mg/kg/day (approximately 9 times the exposure at the rhd [recommended human dose]). treatment of pregnant rabbits with oral telotristat ethyl during organogenesis produced maternal toxicity and post-implantation loss at doses of 250 mg/kg/day or higher (approximately 15 times the exposure at the rhd), and reduced fetal weight at 500 mg/kg/day (approximately 33 times the exposure at the rhd). in a pre-/postnatal development study, an increased incidence of mortality in rat offspring was observed during postnatal days 0 to 4 at the maternal oral do

Israel - English - Ministry of Health

medison pharma ltd - telotristat ethyl as etiprate - film coated tablets - telotristat ethyl as etiprate 250 mg - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (ssa) therapy in adults inadequately controlled by ssa therapy.

European Union - English - EMA (European Medicines Agency)

serb sas - telotristat etiprate - carcinoid tumor; neuroendocrine tumors - other alimentary tract and metabolism products - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (ssa) therapy in adults inadequately controlled by ssa therapy.