Page 11 - Roche Hemlibra Non-inhibitors - Product Monograph

• The half-life of FVIII is short
o 8 to 18 hours for current plasma derived concentrates
o 21 hours for certain (half-life extended) recombinant products

• Thus, the current prophylaxis regimens aim at maintaining FVIII levels at a trough of 1% to partially
restore hemostasis (Valentino et al. 2012)

• However, this target coverage does not provide complete protection
• The development of extended half-life FVIII products results in only a modestly increased half-life by
1.5-fold (Mahlangu et al. 2014; Giangrande et al. 2017; Konkle et al. 2015)

• Patients on FVIII prophylaxis still experience microbleeds resulting in

o progressive arthropathy and long-term joint damage, even in the absence of clinical bleeds
(Kraft et al. 2012; Olivieri et al. 2012)

Lifetime requirement of intravenous infusion:

• Adequate prophylaxis requires a lifetime of self-administered intravenous infusion of FVIII at
least QW to 4 times per week
o It is time consuming (Shapiro et al. 2001)

o It can put considerable strain on patients, caregivers, and families, including frequent
absences from school or work (Shapiro et al. 2001)

Patients should have venous cannulation skills:

• The routine intravenous administration of FVIII relies on venous cannulation skills of patients and
their care providers (Hacker et al. 2001)
• Intravenous administration of FVIII may be a problem because because of the following reasons

o Patients may not be able to administer the drug due to lack of skill especially in children
and elders

o It may be associated with complications contributing to hemophilia associated long-term
morbidity
• Over time, peripheral venous access may prove to become more difficult due to (Guillon et al.
2015)

o Scar formations on the skin and vessels walls
o Leakage

o Injection site bruising
o Vessel thrombosis

HEMLIBRA Monograph-Non-inhibitors | 09
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