Choose HEMLIBRA for your adult and pediatric hemophilia A patients with or without FVIII inhibitors
As demonstrated in a prospective intra-patient comparison: The first and only treatment to show a significant reduction in treated bleed rate vs prior prophylaxis in patients without FVIII inhibitors
As observed over at least 24 weeks (HAVEN 3): Sustained protection meant 0 treated bleeds for most patients
Significantly more patients had zero treated bleeds with HEMLIBRA vs prior FVIII prophylaxis or no prophylaxis
As observed over 24 weeks (HAVEN 1‡): Sustained bleed protection meant zero treated bleeds for most adult and adolescent patients with FVIII inhibitors
Significantly more patients with FVIII inhibitors had zero treated bleeds* with HEMLIBRA QW vs no prophylaxis
- 63% of patients had zero
bleeds vs 6% with no prophylaxis
- 87% fewer bleeds (95% CI: 72.3; 94.3), P<0.0001; ABR† 2.9 (95% CI: 1.7; 5.0) vs 23.3 (95% CI: 12.3; 43.9)
As observed over 30 weeks (HAVEN 2§): Sustained protection meant zero treated bleeds for most pediatric patients
Significantly more patients with FVIII inhibitors had zero bleeds* with HEMLIBRA QW vs no prophylaxis
Median ABR was 0 (IQR: 0; 0) with HEMLIBRA prophylaxis
Note: Same weight-based dosage for all age ranges.
- The prophylactic use of FVIII products may be continued during the first week of HEMLIBRA prophylaxis
- Discontinue the prophylactic use of BPAs the day before starting HEMLIBRA prophylaxis
The selection of a maintenance dose should be based on healthcare provider preference with consideration of regimens that may increase patient adherence
TMA and thrombotic events
- TMA and thrombotic events were reported while treating breakthrough bleeds with aPCC doses averaging >100 U/kg/24 hours for 24 hours during prophylaxis with HEMLIBRA; none were reported in patients with hemophilia A without inhibitors 10
Measuring FVIII inhibitors
Known safety profile established across multiple clinical trials
- The most common adverse reactions (≥10%) were injection site reactions, arthralgia, and headache
ABR=annualized bleed rate; aPCC=activated
prothrombin complex concentrate; BPA=bypassing agent; Cl=confidence
interval; FVlll=factor VIII; IQR=interquartile range;
ISTH=International Society on Thrombosis and Haemostasis; QW=once a
week; Q2W=once every 2 weeks; Q4W=once every 4 weeks; TMA=thrombotic
*Treated bleeds were defined based on an adaptation of standard criteria defined by the ISTH. 12
†ABR was calculated with a negative binomial regression model, accounting for the different follow-up times.
‡ Randomized, multicenter, open-label, clinical trial in 109 adult and adolescent males (aged ≥12 years and ≥40 kg) with hemophilia A with FVIII inhibitors who previously received either episodic (on-demand) or prophylactic treatment with BPAs. Patients received HEMLIBRA prophylaxis 3 mg/kg once weekly for the first 4 weeks followed by 1.5 mg/kg once weekly thereafter, or no prophylaxis. Median ABR in HAVEN 1 was 0 (IQR: 0; 3.7) with HEMLIBRA prophylaxis vs 18.8 (IQR: 13.0; 35.1) with no prophylaxis.
§Single-arm, multicenter, open-label, clinical trial in pediatric males (age <12 years, or 12–17 years who weigh <40 kg) with hemophilia A with FVIII inhibitors. Patients received HEMLIBRA prophylaxis at 3 mg/kg once weekly for the first 4 weeks followed by 1.5 mg/kg QW thereafter.