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bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 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. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

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wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is no informa

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takeda pharmaceuticals america, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 125 [iu] in 1 ml - advate [antihemophilic factor (recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a (congenital factor viii deficiency) for: - control and prevention of bleeding episodes. - perioperative management. - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. advate is not indicated for the treatment of von willebrand disease. advate is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, tris, calcium chloride, polysorbate 80, and/or glutathione). risk summary there are no data with advate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with advate. it is not known whether advate can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. in the u.s. general popu

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takeda pharmaceuticals america, inc. - von willebrand factor human (unii: ze22ne22f1) (von willebrand factor human - unii:ze22ne22f1) - von willebrand factor human 650 [iu] in 5 ml - vonvendi [von willebrand factor (recombinant)] is a recombinant von willebrand factor (rvwf) indicated for use in adults (age 18 and older) diagnosed with von willebrand disease (vwd) for: - on-demand treatment and control of bleeding episodes. - perioperative management of bleeding. - routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe type 3 vwd receiving on-demand therapy. vonvendi is contraindicated in patients who have had life-threatening hypersensitivity reactions to vonvendi or constituents of the product (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins) [see description (11)] . risk summary adequate and well-controlled studies with vonvendi have not been conducted in pregnant women. animal developmental and reproductive toxicity studies have not been conducted with vonvendi. it is not known whether vonvendi can cause fetal harm when administered to a pregnant woman or whether it can affect reprodu

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novo nordisk - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - coagulation factor viia recombinant human 1 mg in 1 ml - novoseven rt, coagulation factor viia (recombinant), is indicated for: none known. risk summary there are no adequate and well-controlled studies using novoseven rt in pregnant women to determine whether there is a drug-associated risk. treatment of rats and rabbits with novoseven in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. at 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. twenty-three out of 25 female rats given 6 mg per kg body weight of novoseven gave birth successfully, however, two of the 23 litters died during the early period of lactation. no evidence of teratogenicity was observed after dosing with novoseven. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is

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aptevo biotherapeutics llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated for the treatment of: - adults and children ≥ 12 years of age with hemophilia b for: on-demand treatment and control of bleeding episodes perioperative management - on-demand treatment and control of bleeding episodes - perioperative management - adults with hemophilia b for: routine prophylaxis to reduce the frequency of bleeding episodes - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated b

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takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

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biogen inc. - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) (unii: 7pcm518ylr) ((1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) - unii:7pcm51 - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or other constituents of the product. [see description (11 )] risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. animal reproductive and devel

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

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - kovaltry is not indicated for the treatment of von willebrand disease. kovaltry is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see description (11)]. there are no data with kovaltry use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using kovaltry. it is not known whether kovaltry can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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. there is no information regarding the presence of kovaltry in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kovaltry and any potential adverse effects on the breastfed infant from kovaltry or from the underlying maternal condition. safety and efficacy studies with kovaltry have been performed in 51 pediatric ptps ≤12 years of age and 43 pediatric pups/mtps <6 years of age [see clinical studies (14)]. body weight adjusted clearance of factor viii in children ≤12 years of age is higher than in adults and adolescents. consider higher or more frequent dosing in children to account for this difference in clearance [see clinical pharmacology (12.3)] . clinical studies with kovaltry did not include patients aged 65 and over to determine whether or not they respond differently from younger patients. however, clinical experience with other factor viii products has not identified differences between the elderly and younger patients. as with any patient receiving recombinant factor viii, dose selection for an elderly patient should be individualized.

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grifols usa, llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 10 ml - alphanine sd is indicated for the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. alphanine sd contains low, non-therapeutic levels of factors ii, vii, and x, and, therefore, is not indicated for the treatment of factor ii, vii or x deficiencies. this product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia a patients with inhibitors to factor viii. none known.