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ABR, annualized bleeding rate; IQR, interquartile range.
In 13 of 25 patients, FIX trough activity was measured 6 to 8 days after dosing with BeneFIX3:
†For each study visit, the recovery value for 1 individual, different in each case, could not be determined for logistical reasons (lack of collection of predose FIX activity, unscheduled visit, or missing information about the dose administered). Of the 17 FIX:C levels observed in 13 patients approximately 1 week after dosing, 8 were >2 IU/dL (min-max, 2.13-10.39 IU/dL).
PK, pharmacokinetics.
In a clinical study of 25 PTPs, zero patients developed an inhibitor while taking BeneFIX once weekly
Adverse reaction |
Number of patients |
---|---|
Inappropriate schedule of drug administration |
6 (24%) |
Arthralgia |
5 (20%) |
Toothache |
5 (20%) |
Upper respiratory tract infection |
5 (20%) |
Drug dose omission |
4 (16%) |
Headache |
4 (16%) |
Fever |
4 (16%) |
Back pain |
3 (12%) |
Local swelling |
3 (12%) |
Medication error |
3 (12%) |
Pharyngitis |
3 (12%) |
Underdose |
3 (12%) |
Wrong dose administered |
3 (12%) |
‡Excludes adverse reaction data from the on-demand treatment period.3
Study description: A multicenter, prospective, open-label clinical trial of 25 patients (age range: 12-54 years) assessed the efficacy and safety of 12 months of BeneFIX 100 IU/kg once-weekly prophylaxis regimen compared with 6 months of on-demand treatment. When administered at a dose of 100 IU/kg once weekly, the ABR for the prophylaxis period was significantly lower (P<0.0001) than the ABR for the on-demand period (mean ± standard deviation [SD]: 3.6 ± 4.6, median: 2.0, min-max: 0-13.8 versus mean: 32.9 ± 17.4, median: 33.6, min-max: 6.1-69.0, respectively). The primary efficacy end point was the ABR, defined as the number of bleeding events per year and calculated as the number of bleeding events/(days on treatment/365.25).2,3
Eligible patients were males aged 12 to 65 years, with moderately severe to severe hemophilia B (FIX:C ≤2%), ≥12 bleeding episodes in the 12-month period before screening (6 of which must have been joint bleeding events), and ≥100 exposure days to FIX products. Patients were excluded if they had a history of or current FIX inhibitors, received FIX as a prophylaxis regimen within 12 months of screening, underwent major surgery or orthopedic surgery in the previous 3 months or if such surgery was planned during study participation, a prothrombin time >1.5x the upper limit of normal (ULN) or an international normalized ratio >1.5, or a platelet count <100,000 µL.3
Common (≥5%) adverse reactions were headache (36%), fever (20%), and cough (8%). No subject was withdrawn from the trial due to an adverse reaction. In the trial, no inhibitors were detected and no thrombotic events or anaphylactic reactions were reported.2
BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation of use:
BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B.
Please see full Prescribing Information for BeneFIX.
BeneFIX, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitation of use:
BeneFIX is not indicated for induction of immune tolerance in patients with hemophilia B.
Please see full Prescribing Information for BeneFIX.
Please see full Prescribing Information.
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