イスラエル - 英語 - Ministry of Health

alexion pharma israel ltd - andexanet alfa - powder for solution for infusion - andexanet alfa 200 mg/vial - andexanet alfa - for adult patients treated with a direct factor xa (fxa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

欧州連合 - 英語 - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - drug-related side effects and adverse reactions - all other therapeutic products - for adult patients treated with a direct factor xa (fxa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

アメリカ合衆国 - 英語 - 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 miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. labor or delivery the safety and effectiveness of andexxa during labor and delivery have not been evaluated. risk summary there is no information regarding the presence of andexxa in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for andexxa and any potential adverse effects on the breastfed child from andexxa or from the underlying maternal condition. the safety and efficacy of andexxa in the pediatric population have not been studied. of the 352 subjects in the annexa-4 study of andexxa, 314 were 65 years of age or older, and 231 were 75 years of age or older. no overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of andexxa in healthy older (≥ 65 years; n=10) subjects were not different compared to younger (18-45 years; n=10) subjects.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - 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 miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. labor or delivery the safety and effectiveness of andexxa during labor and delivery have not been evaluated. risk summary there is no information regarding the presence of andexxa in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for andexxa and any potential adverse effects on the breastfed child from andexxa or from the underlying maternal condition. the safety and efficacy of andexxa in the pediatric population have not been studied. of the 419 subjects in the annexa-4 study of andexxa, 381 (91%) were 65 years of age or older, and 278 (66%) were older than 75 years of age. no overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - andexanet alfa, quantity: 207 mg - injection, powder for - excipient ingredients: arginine hydrochloride; sucrose; mannitol; trometamol hydrochloride; trometamol; polysorbate 80 - andexxa (andexanet alfa) has provisional approval in australia for adult patients treated with a direct factor xa (fxa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.,the decision to approve this indication has been made on the basis of haemostatic efficacy and reduction in anti-fxa activity. continued approval of this indication depends on verification and description of benefit in a confirmatory trial.

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

astrazeneca k.k - andexanet alfa (genetical recombination) - injection

サウジアラビア - 英語 - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astrazeneca ab, sweden - andexanet alfa - powder for solution for infusion - 200 mg,