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Achieve higher Factor VIII levels with ALTUVIIIO1


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

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*

Learn more about how ALTUVIIIO was studied

Adult & Adolescent Trial Design

Achieve higher Factor VIII levels with ALTUVIIIO1

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

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

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Improved bleed protection with once-weekly dosing2

  • 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 profile2
 

  • The most common adverse reactions (>10% of patients) reported in XTEND-1 were headache (20.1%) and arthralgia (16.4%)1
  • No Factor VIII inhibitors were detected in XTEND-11
    • Formation of inhibitors is possible following administration of ALTUVIIIO1

* 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

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Learn how ALTUVIIIO was studied

The XTEND-Kids trial studied ALTUVIIIO in pediatric patients <12 years. 

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See how ALTUVIIIO performed

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

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. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318.

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MAT-US-2403556-v1.0-05/2024 Last Updated: May 2024