FACTOR VIII ACTIVITY
LEVELS MATTER

Lower Factor VIII
levels put patients

at greater risk for
bleeds

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 bleeds1,2

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

A graphic showing the relationship between FVIII levels and activity levels

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

* Data from the 2020 WFH Guidelines for the Management of Hemophilia, 3rd edition.1,7

Data from a study examining a 2001 series of self-reported Dutch surveys that included 433 patients with mild or moderate hemophilia A who were treated on demand.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

Data from a Delphi consensus statement using structured expert opinion to define target factor levels for use in different clinical situations.6

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:

Bleed protection

Provide greater protection from bleeds8,9*†

Joint health

Preserve joint
health1,10,11‡§ǁ

Shoulder pain

Reduce pain1,11,12§ǁ¶

Physical function

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

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

*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.

||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 examining a 2001 series of self-reported Dutch surveys that included 433 patients with mild or moderate hemophilia A who were treated on demand.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 ACTIVITIES4

Factor VIII
Activity Levels

Impact on Physical Activity

Normal levels7
50%-150% factor
activity

None to minimal1,5,6
High-impact
activity possible
with no pain
(sports, physically
taxing jobs).

Near normal1,7*
≥40%-<50%
factor activity

Near-normal factor levels are currently undefined by the
World Federation
of Hemophilia.
 

Mild hemophilia1
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
hemophilia1

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
hemophilia1,3

<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 bleeds1,3-5†

  • *

    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

  • Factor levels should be assessed based on an individual patient basis.

Discover more about this high sustained factor therapy

LEARN ABOUT PK AND MOE

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 is 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.

See full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

WFH=World Federation of Hemophilia.

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

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 is 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.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

aPTT=activated partial thromboplastin time; PK=pharmacokinetics.