A novel FVIII replacement
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| Sponsored Content From Sanofi |
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| Intended for US Payer Audience |
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| Sanofi Specialty Care is pleased to announce that, effective 2/22/2023, ALTUVIIIO is approved for the treatment of adults and children with hemophilia A (congenital factor VIII deficiency) for1: |
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| Routine |
| prophylaxis |
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| On-demand |
| treatment |
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| Perioperative bleed |
| management |
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| ALTUVIIIO is a von Willebrand factor independent recombinant DNA-derived, FVIII concentrate.1 |
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| The recommended dosing for routine prophylaxis for adults and children is 50 IU/kg of ALTUVIIIO administered once weekly.1 |
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| ALTUVIIIO is anticipated to be available in April 2023. |
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| INDICATION |
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| 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: |
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Routine prophylaxis to reduce the frequency of bleeding episodes |
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On-demand treatment & control of bleeding episodes |
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Perioperative management of bleeding |
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| Limitation of Use |
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| ALTUVIIIO is not indicated for the treatment of von Willebrand disease.
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| IMPORTANT SAFETY INFORMATION |
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| CONTRAINDICATIONS |
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| ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients. |
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| WARNINGS AND PRECAUTIONS |
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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. |
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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. |
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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. |
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| ADVERSE REACTIONS |
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| The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia. |
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| Please click here for full Prescribing Information for ALTUVIIIO. |
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| Reference: 1. ALTUVIIIO. Prescribing Information. Bioverativ Therapeutics Inc. |
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| For questions, please contact your Sanofi Specialty Care Account Director. |
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| ©2023 Genzyme Corporation. All rights reserved. |
| ALTUVIIIO and Sanofi are trademarks of Sanofi or an affiliate. |
| MAT-US-2208562-v1.0-02/2023 |
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