Altuviiio logo

Menu

expand_more

About Hemophilia A


Factor VIII Activity Levels Matter

Lower Factor VIII levels put patients at greater risk for bleeds1,2

WFH Guidelines,* along with a retrospective analysis,† have shown that at Factor VIII levels of 5% to <40% (mild hemophilia), patients are vulnerable to traumatic, joint, and surgical bleeds, including subclinical bleeds.1,2

Higher Factor VIII levels are associated with the ability to perform activities with lower risk of a bleed1,3‑6*‡§ll

About Graph

Higher Factor VIII levels reduce bleeding risk and may enable patients to live a more active life1,3‑6*‡§ll

* Data from the 2020 WFH Guidelines for the Management of Hemophilia, 3rd edition.1,7
Data from a study including 63 patients with severe hemophilia A treated with prophylaxis for at least 180 days.2
Data from a 2021 systematic review of physical activity in people with hemophilia across multiple databases, extracted using a standardized template and reported using a narrative synthesis.4
§ Data from an expert elicitation study using Sheffield Elicitation Framework methodology quantified with probability analysis.5
ll Data from a Delphi consensus statement using structured expert opinion to define target factor levels for use in different clinical situations.
WFH Guidelines define the upper limit of mild hemophilia as 40% factor activity, and the WFH Introduction to Hemophilia defines the normal range as 50% to 150%, which indicates that 40% to 50% would be in between mild hemophilia and normal, here referred to as “near-normal” levels.1,7 

Is it time for a higher level of protection?

Achieving higher Factor VIII levels has the potential to:

icon_bandaid.png

Provide greater protection from bleeds8,9*†

icon_joint_1.png

Preserve joint health1,10,11‡§ǁ

icon_pain_1.png

Reduce pain1,11,12§ǁ¶

icon_physical_activity.png

Improve physical function1,4,5,11§ǁ#**

The level of bleed protection depends on the levels of Factor VIII1,2ll††

* Data from a post-hoc analysis of the association of Factor VIII levels and AUC with annualized bleeding rate in 34 patients on pharmacokinetic-guided prophylaxis.8
Data from a 2021 review of prophylaxis in hemophilia with respect to pharmacokinetics, alongside other factors that contribute to clinical decision-making.9
Data from a retrospective analysis of effect of hemophilia type and factor level on joint bleeding and orthopedic procedures in 4771 males with nonsevere hemophilia A or B without inhibitors receiving on-demand factor replacement therapy over a 12-year period.10
§ Data from a randomized, controlled trial of secondary/tertiary prophylaxis vs on-demand treatment in adult and adolescent patients with severe hemophilia A over 3 years.11
ll Data from the 2020 WFH Guidelines for the Management of Hemophilia, 3rd edition.1,7
Data from a post-hoc analysis of patient-reported pain surveys and joint health examinations assessing the association of demographic and clinical characteristics with perceptions of pain and functional abilities in 240 adult patients with hemophilia A or B (with or without inhibitors) and a history of joint pain or bleeding.12
# Data from a 2021 systematic review of physical activity in people with hemophilia across multiple databases, extracted using a standardized template and reported using a narrative synthesis.4
** Data from an expert elicitation study using Sheffield Elicitation Framework methodology quantified with probability analysis.5
†† Data from a study including 63 patients with severe hemophilia A treated with prophylaxis for at least 180 days.2

Improving bleed protection may allow closer-to-normal activity for patients with hemophilia A

Factor VIII levels and their impact on the ability to perform activities

Factor VIII Activity Levels1,3,6,7,13Impact on Physical Activity1,3,6,13
Normal levels
50%-150% factor activity
None to minimal1,5,6
High-impact activity possible with no pain (sports, physically taxing jobs).
Near normal*
≥40%-<50% factor activity
Near-normal factor levels are currently undefined by the World Federation of Hemophilia.
Mild hemophilia
5%-<40% factor activity
Minor6,13
High-risk activity is possible. Intensive sport activity may be considered for those with factor levels between 15%-30%. Appropriate level of physical activity should be evaluated on a case-by-case basis. May experience pain and limited mobility.
Moderate hemophilia
1%-5% factor activity
Moderate6,13
Factor levels between 1%-3% may be sufficient for those with a sedentary lifestyle, but higher levels between 3%-5% are recommended if engaging in mild physical activity. Individuals should refrain from high-risk activity. May experience pain and limited mobility.
Severe hemophilia
<1% factor activity
Major1,5,6
High risk of spontaneous bleeds—even with low activity there will be pain in target joints.

As Factor VIII levels approach normal, patients are less likely to experience bleeds1†

* WFH Guidelines define the upper limit of mild hemophilia as 40% factor activity, and the WFH Introduction to Hemophilia defines the normal range as 50% to 150%, which indicates that 40% to 50% would be in between mild hemophilia and normal, here referred to as “near-normal” levels.1,14
Factor levels should be assessed based on an individual patient basis.

icon_arrow.png

Learn the mechanism of ALTUVIIIO

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

icon_charts_v2.png

See how ALTUVIIIO performed

Learn about bleed protection for adult and adolescent 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

AUC=area under the curve; FVIII=Factor VIII; MOE=mechanism of extension; PK=pharmacokinetics; WFH=World Federation of Hemophilia.

References: 1. Srivastava A, et al. Haemophilia. 2020;26(suppl 6):1-158. 2. Chowdary P, et al. Thromb Haemost. 2020;120(5):728-736. 3. Centers for Disease Control and Prevention. Diagnosis of Hemophilia. Updated August 1, 2022. Accessed January 8, 2023. https://www.cdc.gov/ncbddd/hemophilia/diagnosis.html 4. Kennedy M, et al. Haemophilia. 2021;27(4):544-562. 5. Martin AP, et al. Haemophilia. 2020;26(4):711-717. 6. Iorio A, et al. Haemophilia. 2017;23(3):e170-e179. 7. National Hemophilia Foundation. Hemophilia A. Accessed January 8, 2023. https://www.hemophilia.org/bleeding-disorders-a-z/types/hemophilia-a 8. Valentino LA, et al. Haemophilia. 2016;22(4):514-520. 9. Berntorp E, et al. Blood Rev. 2021;50:100852. 10. Soucie JM, et al. Blood Adv. 2018;2(16):2136-2144. 11. Manco-Johnson MJ, et al. J Thromb Haemost. 2017;15(11):2115-2124. 12. Kempton CL, et al. Eur J Haematol. 2018;100(suppl 1):25-33. 13. Skinner MW, Nugent et al. Haemophilia. 2020;26(1):17-24. 14. Hemophilia. eLearning Platform. (2023, December 15). WFH website. eLearning platform: Hemophilia. https://elearning.wfh.org/elearning-centres/hemophilia/ Accessed April 17, 2024.

© 2024 Sanofi. All rights reserved. ALTUVIIIO, MyALTUVIIIO, and Sanofi are registered trademarks of Sanofi or an affiliate.

MAT-US-2403557-v1.0-05/2024 Last Updated: May 2024