ALTUVIIIO (antihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl) · Sanofi

The PK of ALTUVIIIO were evaluated in prospective, open-label clinical studies, enrolling 159 adults and adolescents, and 74 children <12 years old, respectively, receiving weekly IV injections of 50 IU/kg. Among children <12 years old, 37 patients had ALTUVIIIO single dose PK profiles available. PK parameters following a single dose of ALTUVIIIO are presented in Table 4. The PK parameters were based on plasma FVIII activity measured by the aPTT-based one-stage clotting assay. After a single dos...

The safety, efficacy, and pharmacokinetics of ALTUVIIIO were evaluated in two multicenter, prospective, open-label clinical studies,

Study 1(NCT04161495) and

Study 2(NCT04759193), as described below. All studies evaluated the efficacy of routine prophylaxis with a weekly dose of 50 IU/kg and determined hemostatic efficacy in the treatment of bleeding episodes and during perioperative management in patients undergoing major or minor surgical procedures. Routine Prophylaxis to Reduce Bleeding Episodes Study 1 (Adult and Adolescent Study) Study 1 enrolled a total of 159 previously treated patie...

Most common adverse reactions (incidence >10%) are headache and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bioverativ Therapeutics Inc. (A SANOFI COMPANY) at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may no...

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients [see Description (11) ] . Do not use in patients who have had severe hypersensitivity reactions, including anaphylaxis, to ALTUVIIIO or excipients of ALTUVIIIO. ( 4 )

Hypersensitivity reactions, including anaphylaxis, have occurred with ALTUVIIIO. If symptoms occur, immediately discontinue ALTUVIIIO and initiate appropriate treatment. ( 5.1 ) Neutralizing antibodies (inhibitors) to Factor VIII have been reported. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. ( 5.2 , 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitiv...