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BeneFIX in PTPs
BeneFIX in children < 6 years
BeneFIX in surgery
BeneFIX* experience in PTPs: (Roth DA, et al. 2001)
Aim / overview:
Patients:
56 patients from at 20 sites throughout North America and Europe were enrolled and received BeneFIX.2
Outcomes:
BeneFIX is clinically effective in the treatment and prevention of bleeding in individuals with hemophilia B.2
Reformulated BeneFIX* experience in PTPs: (Lambert T, et al. 2007)
Aim / overview:
Patients:
34 subjects were randomised to receive a single 75 IU/ kg dosage of BeneFIX or reformulated BeneFIX3
Outcomes:
BeneFIX has been reformulated and the reformulated product is effective for treatment of haemophilia B.3
BeneFIX* experience in PTPs: (Korth-Bradley JM, et al. 2016)
Aim / overview:
Patients:
Outcomes:
BeneFIX was effective for on-demand treatment, routine prophylaxis, and surgical prophylaxis in previously treated patients with moderately severe to severe hemophilia B.4
*On demand dose: The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/ dL) in patients ≥ 12 years.
The required dosage is determined using the following formula: Number of factor IX IU required = body weight (in kg) X desired factor IX increase (%) or (IU/dL) X reciprocal of observed recovery
Prophylaxis dose: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for PTP was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.1
†Excellent: dramatic response with abrupt pain relief and clear reduction in joint or haemorrhage site size; Good: pain relief or reduction in haemorrhage site size which was delayed or required additional infusion for resolution.3
‡Response was evaluated by the patient or caregiver or by the investigator using a 4-point scale.4
BMI: body mass index; Cmax: peak plasma concentration; FIX: factor IX; IU: international unit; PK: pharmacokinetic; PTP: previously treated patient
BeneFIX experience in children <6 years (PUPs and PTPs): (Monahan PE, et al. 2010)
Aim / overview:
Patients:
Outcomes:
Regular BeneFIX infusions effectively controlled and prevented hemorrhages in the 22 efficacy evaluable subjects, all of whom were prescribed routine prophylaxis.2
*Mean dosage in pediatric population (± standard deviation) for prophylaxis was 64.6 (±21.3) IU/kg.2 Please refer to the local label for approved dosages.
FIX: factor IX; IU: international unit; PTP: previously treated patient; PUPs: Previously untreated patients.
BeneFIX experience in surgery: (Ragni MV, et al. 2002)
Aim / overview:
Patients:
BeneFIX was evaluated in 28 subjects with FIX deficiency (including 26 with mild, moderate or severe haemophilia B and two haemophilia B carriers) undergoing 36 surgical procedures2
Outcomes:
BeneFIX was found to be effective in achieving haemostasis in subjects with FIX deficiency undergoing surgery2
*Excellent: the response was as satisfactory, with as much and as rapid an improvement as the best responses with other FIX products for similar bleeds or procedures; Good: the response was as satisfactory, with as much and as rapid an improvement as most responses with other FIX products for similar bleeds or procedures.2
FIX: factor IX; rFIX: recombinant factor IX.
Approval No. : BV0098A2259/032022 Invalidation Date: 17/02/2025 |
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