Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bioverativ therapeutics inc. - efanesoctocog alfa (unii: wh7bhq0rb4) (efanesoctocog alfa - unii:wh7bhq0rb4) - altuviiio [antihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl] is a von willebrand factor (vwf) independent recombinant dna-derived, factor viii concentrate indicated for use in adults and children with hemophilia a (congenital factor viii deficiency) for: - routine prophylaxis to reduce the frequency of bleeding episodes - on-demand treatment and control of bleeding episodes - perioperative management of bleeding limitation of use altuviiio is not indicated for the treatment of von willebrand disease. altuviiio is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients [see description (11)] . risk summary there are no data with altuviiio use in pregnant women to inform a drug-associated risk. animal developmental and reproductive studies have not been conducted with altuviiio. therefore, it is not known whether altuviiio can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s.