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ALTUVIIIO® [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] logo

ALTUVIIIO is the first and only once-weekly
Factor VIII replacement therapy of its kind1,3


Once-weekly ALTUVIIIO is a first-in-class, high-sustained Factor VIII replacement therapy that provides normal to near-normal levels (>40%) for most of the week in adults.1,3†

Watch how switching to ALTUVIIIO can make a difference

Achieve higher Factor VIII levels with ALTUVIIIO1

ALTUVIIIO is the #1 most-prescribed Factor VIII replacement therapy4

learn more pharmacokinetics

Normal to near-normal
Factor VIII levels for most of the week in adults1

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

Proven bleed protection with once-weekly dosing3

  • Routine prophylaxis (n=128) resulted in a median ABR of 0.0 (Q1, Q3: 0.0-1.0) and a mean ABR of 0.7 (95% CI: 0.5-1.0)§
  • Significant improvement in bleed protection in the intrapatient comparison group (n=78): 77% reduction in mean ABR vs prestudy Factor VIII prophylaxis§
     
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Established safety profile1,3 
 

  • The most common adverse reactions (>10% of patients) reported in XTEND-1 were headache (20%) and arthralgia (16%)1
  • Formation of inhibitors has been reported following the administration of ALTUVIIIO in the postmarketing setting1II
    • No Factor VIII inhibitors were detected in the XTEND-1 trial3

* Based on specialty pharmacy channel and HTC-reported data from October 2023 to April 2026.2
† Data from the Phase 3 XTEND-1 study in 125 adults ≥18 years receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO.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
§ Based on treated bleeds.1
II In the postmarketing setting, reports are derived from a population of uncertain size; therefore, it is not always possible to reliably estimate frequency or establish a causal relationship to drug exposure.1

Learn how ALTUVIIIO was studied

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

Icon how ALT performed

See how ALTUVIIIO performed

ALTUVIIIO has efficacy data in the prophylaxis, on-demand, and perioperative settings for pediatric patients. 

Indication

ALTUVIIIO® is indicated for use in adults and pediatric patients 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.

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, have occurred with ALTUVIIIO. Discontinue use of ALTUVIIIO if hypersensitivity reaction occurs and manage symptoms as appropriate.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ALTUVIIIO. 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.

Indication

Important Safety Information

ABR=annualized bleed rate; aPTT=activated partial thromboplastin time; CI=confidence interval; IU=international unit; IV=intravenous; PK=pharmacokinetics; Q1=25th percentile; Q3=75th percentile; SD=standard deviation.

References: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 2. Data on file. April 2026. 3. Wong N, et al. J Clin Pharmacol. 2025;65(7):860-872. 4. Data on file. February 2026. 5. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318.

© 2026 Sanofi. All rights reserved. All trademarks mentioned are the property of the Sanofi group. MAT-US-2403556-v6.0-06/2026 Last Updated: June 2026