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Adult & Adolescent Study - Pharmacokinetics


Only ALTUVIIIO provided Factor VIII activity levels in the normal to near-normal (>40%) range for most of the week in the Phase 1 study of adults1

Phase 1 sequential PK study2

Pharmacokinetics chart

Lower interpatient variability vs an SHL and EHL* was observed in the Phase 1 study across PK parameters2†

* Data from a Phase 1 trial in 13 previously treated adults with severe hemophilia A. Pharmacokinetic profiles of ALTUVIIIO, Advate® [Antihemophilic Factor (Recombinant)], and Adynovate® [Antihemophilic Factor (Recombinant), PEGylated] were evaluated after sequential IV infusions. Primary objective: assess the elimination half-life for each product. Secondary objectives: characterization of additional PK parameters; evaluation of safety and tolerability of ALTUVIIIO.3
† Lower interpatient variability assessed across PK parameters (AUC, half-life, clearance) was also seen in XTEND-1.4
Advate and Adynovate are registered trademarks of Baxalta Incorporated, a Takeda company.

Normal to near-normal Factor VIII activity levels for most of the week were also seen in the Phase 3 XTEND-1 trial4*

Phase 3 XTEND-1 sequential PK subgroup (n=17)4

Sequential chart_XTEND-1

XTEND-1 trial adult study population (n=125)1

Once-weekly ALTUVIIIO provided


  • ~4 days with mean Factor VIII levels above 40% (normal to near-normal range)1
  • Factor VIII trough levels of 18.0%1†
    • Factor VIII clearance has been demonstrated to be higher in patients <18 years, resulting in lower trough levels1

The pharmacokinetic profile was similar after the first dose and after 26 weeks of weekly dosing. A steady state was achieved after the first dose of ALTUVIIIO.1

Once-weekly 50 IU/kg ALTUVIIIO provided Factor VIII activity levels that were associated with a low bleed risk5

* Data from the Phase 3 XTEND-1 study in 134 adults (≥18 years) receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO. PK parameters shown are based on plasma Factor VIII activity measured by the aPTT-based one-stage clotting assay.1
† Mean trough level was computed using available measurements at Week 52/end of study PK sampling visit for the adult population in the XTEND-1 study (n=123).1

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Learn how ALTUVIIIO was studied

The XTEND-1 trial studied ALTUVIIIO in the prophylaxis, on-demand, and perioperative settings in adult and adolescent patients.

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Learn the mechanism of ALTUVIIIO

Discover more about how this high sustained factor therapy works in adult and adolescent patients.

Indication

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 & control of bleeding episodes
  • Perioperative management of bleeding
Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

Important Safety Information
Contraindications

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

Warnings and Precautions
  • Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII are possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
  • If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.
Adverse Reactions

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

IndicationImportant Safety Information

aPTT=activated partial thromboplastin time; AUC=area under the curve; FVIII=Factor VIII; IU=international unit; IV=intravenous; PK=pharmacokinetic; rFVIII=recombinant Factor VIII; SD=standard deviation.

References: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 2. Lissitchkov T, et al. Res Pract Thromb Haemost. 2023;7(4):100176. 3. Lissitchkov T, et al. Haemophilia. 2022;1227074. 4. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318.

© 2024 Sanofi. All rights reserved. ALTUVIIIO, MyALTUVIIIO, and Sanofi are registered trademarks of Sanofi or an affiliate.

MAT-US-2403560-v1.0-05/2024 Last Updated: May 2024