Page 4 - Roche Hemlibra Non-inhibitors - Product Monograph

2. CLINICAL FEATURES OF HEMOPHILIA A

Underproduction or dysfunction of FVIII leads to a lifelong bleeding tendency.

Common clinical signs of hemophilia A include:

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Spontaneous
Prolonged bleeding into
bleeding after Delayed joints, muscles, or
Bruising trauma wound healing soft tissues;
or surgery and intracranial
hemorrhage

The main types of bleeding are as follows:

Intra articular Intramuscular Subcutaneous

Gastrointestinal Mucocutaneous Intracranial

3. DISEASE BURDEN

Although hemophilia A is a rare disease, it exerts a substantial humanistic, societal, and
economic burden on individuals, caregivers, and healthcare systems. Hemophilia affects
interpersonal relationships and educational, career and lifestyle choices. Patients with
hemophilia experience diminished quality of life as a result of bleeding events, chronic pain,
and other disease complications and parents of children with hemophilia have decreased

HRQoL compared with the general population.

3.1. HUMANISTIC BURDEN
The complications associated with spontaneous and prolonged bleeding lead to increased
morbidity in patients with hemophilia A, especially in patients with severe disease. Severe
hemophilia has lower levels of FVIII and is associated with a significantly higher number of

annual bleeding episodes compared with mild hemophilia (Zhou et al. 2015). Severe hemophilia
is characterized by recurrent spontaneous bleeds typically into joints, muscles, or
subcutaneously, and potentially life threatening gastrointestinal or intracranial hemorrhages.

HEMLIBRA Monograph-Non-inhibitors | 02
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