Israel - English - Ministry of Health

medison pharma ltd - odevixibat as sesquihydrate - hard capsule - odevixibat as sesquihydrate 1200 mcg - odevixibat - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or olderbylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with alagille syndrome (algs).

Israel - English - Ministry of Health

medison pharma ltd - odevixibat as sesquihydrate - hard capsule - odevixibat as sesquihydrate 200 mcg - odevixibat - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or olderbylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with alagille syndrome (algs).

Israel - English - Ministry of Health

medison pharma ltd - odevixibat as sesquihydrate - hard capsule - odevixibat as sesquihydrate 400 mcg - odevixibat - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or olderbylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with alagille syndrome (algs).

Israel - English - Ministry of Health

medison pharma ltd - odevixibat as sesquihydrate - hard capsule - odevixibat as sesquihydrate 600 mcg - odevixibat - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or olderbylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with alagille syndrome (algs).

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

ipsen biopharmaceuticals, inc. - odevixibat (unii: 2w150k0uuc) (odevixibat - unii:2w150k0uuc) - bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with pfic. limitations of use - bylvay may not be effective in a subgroup of pfic type 2 patients with specific abcb11 variants resulting in non-functional or complete absence of the bile salt export pump protein [see clinical pharmacology (12.5) and clinical studies (14)]. bylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with algs. none risk summary there are no human data on bylvay use in pregnant persons to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. based on findings from animal reproduction studies, bylvay may cause cardiac malformations when a fetus is exposed during pregnancy. in pregnant rabbits treated orally with odevixibat during organogenesis, an increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites occurred at all doses; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended dose (see data) . the estimated 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. there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to bylvay during pregnancy. pregnant women exposed to bylvay, or their healthcare providers, should report bylvay exposure by calling 1-855-463-5127. data animal data in an embryo-fetal development study, pregnant rabbits received oral doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. fetuses from all maternal groups treated with odevixibat showed an increase in cardiovascular malformations, which included 5-chambered heart, small ventricle, large atrium, ventricular septum defect, misshapen aortic valve, dilated aortic arch, right sided and retroesophageal aortic arch, fusion of aortic arch and pulmonary trunk, ductus arteriosus atresia, and absence of subclavian artery. these malformations occurred at 2.1 times the maximum recommended dose and higher, based on auc (area under the plasma concentration-time curve). odevixibat was shown to cross the placenta in pregnant rats. no adverse effects on embryo-fetal development were observed following oral administration of 100, 300, or 1,000 mg/kg/day in pregnant rats during organogenesis. an increase in skeletal variations (delayed/incomplete ossification and thick ribs) was observed at 1,000 mg/kg/day. maternal systemic exposure to odevixibat at the maximum dose tested was 272 times the maximum recommended dose, based on auc. no adverse effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 1,000 mg/kg/day during organogenesis through lactation. the maternal auc for odevixibat at 1,000 mg/kg/day was 434 times the maximum recommended dose, based on auc. risk summary odevixibat has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant to bylvay at the recommended doses [see clinical pharmacology (12.3)]. there are no data on the presence of odevixibat in human milk, the effects on the breastfed infant, or the effects on milk production. bylvay may reduce absorption of fat-soluble vitamins [see warning and precautions (5.3)] . monitor fsv levels and increase fsv intake, if fsv deficiency is observed during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bylvay and any potential adverse effects on the breastfed child from bylvay or from the underlying maternal condition. the safety and effectiveness of bylvay have been established in pediatric patients 3 months to 17 years of age for the treatment of pruritus in pfic. use of bylvay in this age group is supported by evidence from one randomized, double-blind, placebo-controlled trial conducted in 62 patients with a confirmed diagnosis of pfic type 1 or type 2 (trial 1), and an open-label extension trial in pfic patients (trial 2) [see adverse reactions (6.1) and clinical studies (14)] . the safety and effectiveness of bylvay for the treatment of pruritus in pfic in pediatric patients less than 3 months of age have not been established. the safety and effectiveness of bylvay have been established in pediatric patients 12 months to 17 years of age for the treatment of pruritus in algs. use of bylvay in this age group is supported by evidence from one randomized, double-blind, placebo-controlled trial conducted in 52 patients with a confirmed diagnosis of algs (trial 3) and one open-label extension trial in algs patients (trial 4) [see adverse reactions (6.1) and clinical studies (14)] . the safety and effectiveness of bylvay for the treatment of pruritus in algs in pediatric patients less than 12 months of age have not been established. pfic and algs are largely diseases of pediatric and young adult patients. clinical studies in bylvay did not include patients 65 years of age and older. patients with pfic and algs may have impaired hepatic function. the efficacy and safety of bylvay in pfic and algs patients with clinically significant portal hypertension, and in patients with decompensated cirrhosis have not been established [see clinical studies (14), dosage and administration (2.3), and warning and precautions (5.1)]. this instructions for use contains information on how to give bylvay capsules and oral pellets. this information does not take the place of talking to your healthcare provider about your child's medical condition or their treatment. important information you need to know before giving or taking bylvay - give bylvay along with the morning meal . - mix bylvay in a small amount of soft food (up to 2 tablespoons [30 ml]), such as apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding, in a bowl. you may also mix bylvay with an age-appropriate liquid and give through an oral syringe. - if your child is taking bile acid binding resins (for example, cholestyramine, colestipol), give them bylvay at least 4 hours before or 4 hours after they take the bile acid binding resin. preparing to give bylvay you will be provided with the number of bylvay capsules or oral pellets prescribed by your child's healthcare provider in a child-resistant closure. giving bylvay oral pellets with soft food: - the shell containing oral pellets are to be opened and sprinkled. do not let your child swallow the shell containing the oral pellets. dispose of (throw away) the emptied shell. - mix the contents of the oral pellets with soft food as shown in steps 1 through 9 below. giving bylvay oral pellets with liquids (using an oral dosing syringe): - the shell containing the oral pellets are to be opened. - mix the oral pellets with liquid as shown in steps 1 through 14 below. - dispose of (throw away) the emptied shells. do not let your child swallow the unopened shells containing the oral pellets. taking bylvay capsules - take bylvay capsules along with your morning meal . swallow bylvay capsules whole with a glass of water. do not chew or crush the capsules. - for children unable to swallow bylvay capsules whole, follow instructions under preparing to give bylvay above. how should i store bylvay capsules or oral pellets? store bylvay at room temperature between 68°f to 77°f (20°c to 25°c). disposing (throwing away) of bylvay capsules or oral pellets shells. dispose of (throw away) the empty bylvay capsule or oral pellets shells in the household trash. what are the ingredients in bylvay? active ingredient: odevixibat. inactive ingredients: hypromellose and microcrystalline cellulose. manufactured for: ipsen biopharmaceuticals, inc. one main street, cambridge, ma 02142 © 2024 ipsen biopharmaceuticals, inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 01/2024

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

albireo pharma, inc. - odevixibat (unii: 2w150k0uuc) (odevixibat - unii:2w150k0uuc) - bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with pfic. limitations of use - bylvay may not be effective in a subgroup of pfic type 2 patients with specific abcb11 variants resulting in non-functional or complete absence of the bile salt export pump protein [see clinical pharmacology (12.5) and clinical studies (14)]. bylvay is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with algs. none risk summary there are no human data on bylvay use in pregnant persons to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. based on findings from animal reproduction studies, bylvay may cause cardiac malformations when a fetus is exposed during pregnancy. in pregnant rabbits treated orally with odevixibat during organogenesis, an increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites occurred at all doses; maternal systemic exposure at the

European Union - English - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - bile and liver therapy - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4.4 and 5.1).

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

regeneron pharmaceuticals, inc. - atoltivimab (unii: fjz07q63vy) (atoltivimab - unii:fjz07q63vy), maftivimab (unii: kop95331m4) (maftivimab - unii:kop95331m4), odesivimab (unii: uy9lq8p6hw) (odesivimab - unii:uy9lq8p6hw) - inmazeb is indicated for the treatment of infection caused by zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is rt-pcr positive for zaire ebolavirus infection [see dosage and administration (2.2), and clinical studies (14)] . limitations of use the efficacy of inmazeb has not been established for other species of the ebolavirus and marburgvirus genera. zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. consider available information on drug susceptibility patterns for circulating zaire ebolavirus strains when deciding whether to use inmazeb. none. risk summary zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy (see clinical considerations). available data from the palm trial and an expanded access program in which pregnant women with zaire ebolavirus infection we

Singapore - English - HSA (Health Sciences Authority)

eisai (singapore) pte. ltd. - elobixibat monohydrate eqv elobixibat - tablet, film coated - elobixibat monohydrate eqv elobixibat 5 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

novag infancia, s.a de c.v. - clopidogrel - clopidogrel....75.00 mg