Page 32 - Roche Hemlibra Non-inhibitors - Product Monograph

8. ADMINISTRATION AND DOSING OF HEMLIBRA ®

HEMLIBRA dosages and strengths'

Sky Blue: 30 mg/ml Purple: 60 mg/0.4 ml Turquoise: 105 mg/0.7 ml Brown: 150 mg/ml

HEMLIBRA is available in 2 concentrations: Different vial concentrations should not be combined in the same syringe.
30 mgirl (30-mg vial) Stable at room temperature (below 30"C)
150 mo/ml. (60-mg. 105-mg, and 150-mg vials) up to a cumulative total of 7 days
No requirement for routine laboratory monitoring

Required injection supplies*
Transfer needle Syringe Injection needle

+ +

Following initial administration by a healthcare provider and sufficient training of the patient in
medication preparation and subcutaneous injection technique, HEMLIBRA is intended for self
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administration at home or administration by a caregiver at home. In contrast, plasma derived or
recombinant FVIII concentrate is administered intravenously, usually by the patient or caregiver at
home and current prophylactic regimens require the administration of multiple doses per week.

9. TAKE HOME MESSAGES
• Although currently available FVIII replacement therapies comprise the cornerstone of
hemophilia A management, they provide only incomplete coverage and do not restore normal
health and lifestyle to patients.

• Given the inadequate efficacy and the considerable management challenges in adults and
children with hemophilia A, there is a true need for therapeutics that provide improved efficacy
to prevent bleeding and minimize long term morbidity, along with a reduction in treatment
burden.

• HEMLIBRA is the first and only treatment for hemophilia A so far to show superior efficacy over
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FVIII prophylaxis, with a higher proportion of patients staying free of bleeds and significantly
reduced bleed rates.

• HEMLIBRA can be administered QW (or even less often) and subcutaneously, which provides a
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considerable reduction in treatment burden compared with the current standards of care and
leaves the patient the choice for the most appropriate treatment regimen.
• HEMLIBRA , with its consistent and clinically meaningful efficacy, an acceptable safety profile,
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and positive benefit risk profile, represents a substantial improvement over currently available
treatment options and has the potential to address the current unmet needs of hemophilia A
patients across age groups.

HEMLIBRA Monograph-Non-inhibitors | 30
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