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Pediatric Study - Pharmacokinetics


Deliver ~3 days near normal for your pediatric patients1

In children <12 years, ALTUVIIIO provided mean steady-state Factor VIII levels >40% for ~3 days and an unprecedented trough level of 10% at ~Day 71

Phase 3 XTEND-Kids FVIII activity after first dose in PK subgroup2*

End of study population (N=73)1

Once-weekly ALTUVIIIO delivered Factor VIII trough levels:

  • 10.9% in children <6 years
  • 16.5% in children 6 to <12 years

* Data from this subgroup analysis includes 37 children (<12 years) receiving a weekly IV infusion of 50 IU/kg ALTUVIIIO. PK parameters shown are based on plasma FVIII activity measured by the aPTT-based one-stage clotting assay.1
Mean steady-state trough levels were computed using available measurements at Week 52/end of study PK sampling visit for the pediatric population in the XTEND-Kids study (n=72).1

ALTUVIIIO offered a mean half-life of 40.2 hours in children <12 years—the longest of any Factor VIII replacement therapy1-11‡

Comparison of data from XTEND-Kids with half-life data recorded in Prescribing Information of approved Factor VIII replacement therapies.

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Learn how ALTUVIIIO was studied

The XTEND-Kids trial studied ALTUVIIIO in patients <12 years with severe hemophilia A.

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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

References: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 2. Data on file, May 2023. 3. Advate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 4. Adynovate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 5. Afstyla Prescribing Information. CSL Behring LLC. Kankakee, IL. 6. Eloctate Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 7. Esperoct Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 8. Kovaltry Prescribing Information. Bayer HealthCare LLC. Whippany, NJ. 9. Novoeight Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 10. Nuwiq Prescribing Information. Octapharma USA, Inc. Paramus, NJ. 11. Xyntha Prescribing Information. Wyeth Pharmaceuticals LLC. Philadelphia, PA.

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MAT-US-2403559-v1.0-05/2024 Last Updated: May 2024