ALTUVIIIO® Half-Life Extension | Sanofi

Achieving high sustained mean Factor VIII levels (>40%) for most of the week in adults by overcoming the half-life limitations of von Willebrand Factor (vWF)^1-3

THE HALF-LIFE OF FACTOR VIII IS EXTENDED WITH NATURAL AMINO ACIDS^1-4*

FACTOR VIII^1,3,4

At the core of ALTUVIIIO is rFVIII, which replaces deficient FVIII in patients with hemophilia A

Fc DOMAIN^1,3,4

Delays FVIII degradation, and helps FVIII stay in circulation by slowing the clearance rate

XTEN POLYPEPTIDE INSERTION^1,3,4

Shields the FVIII molecule from proteolytic degradation and reduces binding to clearance receptors

vWF D’D3 DOMAIN⁴

Prevents binding of FVIII to endogenous vWF

ALTUVIIIO is uniquely designed to be independent of the vWF chaperone^3,4

* ALTUVIIIO is composed of naturally occurring amino acids that are able to be broken down through regular protein degradation processes.⁴

Discover how ALTUVIIIO achieves higher sustained mean Factor VIII levels (>40%)^1-3

In a Phase 3 study, ALTUVIIIO offered a 48.2-hour half life in adults—the longest of any Factor VIII replacement therapy^4-15†

^†Comparison of data from XTEND-1 with half-life data recorded in prescribing information of approved Factor VIII replacement therapies.

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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How ALTUVIIIO works

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

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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.

Please see full Prescribing Information.

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Indication

Important Safety Information

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

References: 1. von Drygalski A, et al. N Engl J Med. 2023;388(4):310-318. 2. Chhabra ES, et al. Blood. 2020;135(17):1484-1496. 3. Konkle BA, et al. N Engl J Med. 2020;383(11):1018-1027. 4. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 5. Adynovate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 6. Afstyla Prescribing Information. CSL Behring LLC. Kankakee, IL. 7. Eloctate Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 8. Esperoct Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 9. Kovaltry Prescribing Information. Bayer HealthCare LLC. Whippany, NJ. 10. Novoeight Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 11. Nuwiq Prescribing Information. Octapharma USA, Inc. Paramus, NJ. 12. Xyntha Prescribing Information. Wyeth Pharmaceuticals LLC. Philadelphia, PA. 13. Advate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 14. Jivi Prescribing Information. Bayer Healthcare LLC. Whippany, NJ. 15. Recombinate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA.

Mechanism of half-life extension (MOE)

Achieving high sustained mean Factor VIII levels (>40%) for most of the week in adults by overcoming the half-life limitations of von Willebrand Factor (vWF)1-3

THE HALF-LIFE OF FACTOR VIII IS EXTENDED WITH NATURAL AMINO ACIDS1-4*

FACTOR VIII1,3,4

Fc DOMAIN1,3,4

XTEN POLYPEPTIDE INSERTION1,3,4

vWF D’D3 DOMAIN4

ALTUVIIIO is uniquely designed to be independent of the vWF chaperone3,4

Discover how ALTUVIIIO achieves higher sustained mean Factor VIII levels (>40%)1-3

In a Phase 3 study, ALTUVIIIO offered a 48.2-hour half life in adults—the longest of any Factor VIII replacement therapy4-15†

Learn how ALTUVIIIO was studied

How ALTUVIIIO works

Indication

Limitation of Use

Important Safety Information

Contraindications

Warnings and Precautions

Adverse Reactions

Indication

Important Safety Information

Achieving high sustained mean Factor VIII levels (>40%) for most of the week in adults by overcoming the half-life limitations of von Willebrand Factor (vWF)^1-3

THE HALF-LIFE OF FACTOR VIII IS EXTENDED WITH NATURAL AMINO ACIDS^1-4*

FACTOR VIII^1,3,4

Fc DOMAIN^1,3,4

XTEN POLYPEPTIDE INSERTION^1,3,4

vWF D’D3 DOMAIN⁴

ALTUVIIIO is uniquely designed to be independent of the vWF chaperone^3,4

Discover how ALTUVIIIO achieves higher sustained mean Factor VIII levels (>40%)^1-3

In a Phase 3 study, ALTUVIIIO offered a 48.2-hour half life in adults—the longest of any Factor VIII replacement therapy^4-15†