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Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

Read Important Information on Helixate® FS, Antihemophilic Factor (Recombinant)

AFSTYLA Delivers Reliable Bleed Control When Your Patients Need It

Proven on-demand control

On-demand chart: 94% and 96% of all bleeds were controlled with 1 to 2 infusions of AFSTYLA (adult and pediatric groups respectively)

Note: 6% of patients ≥12 years and 4% of patients <12 years needed ≥3 infusions to control bleeding.

Study design

Data from two AFSTYLA studies

Phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III open-label, multicenter study in patients <12 years.

Adult/adolescent study

A total of 848 bleeding episodes were treated with AFSTYLA and 835 received an efficacy assessment by the investigator. The majority of the bleeding episodes occurred in joints. The median dose per injection used to treat a bleeding episode was 31.7 IU/kg.

Pediatric study

A total of 347 bleeding episodes were treated with AFSTYLA and received an efficacy assessment by the investigator. The majority of bleeding episodes occurred in joints. The median dose per injection used to treat a bleeding episode was 27.3 IU/kg.

Dependable perioperative management

100% of surgeries had excellent or good bleeding control

With AFSTYLA, perioperative bleeding control was rated "excellent" in 15 surgeries and "good" in 1 surgery (n=16).

Median factor consumption on the day of surgery was 89.4 IU/kg (range 40.5–108.6 IU/kg).

Note: Treating physicians rated surgical hemostatic efficacy of AFSTYLA on a 4-point scale: Excellent (hemostasis not clinically different from normal), Good (normal or mildly abnormal hemostasis), Moderate (moderately abnormal hemostasis), Poor/No response (severely abnormal hemostasis).

Study design

AFSTYLA data from a phase I/III, open-label, multicenter, crossover study in patients 12 years and over. Investigators assessed hemostatic efficacy of AFSTYLA in 13 adult/adolescent patients with severe hemophilia A who underwent a total of 16 surgical procedures.

Surgeries studied

Extraction of wisdom teeth, abdominal hernia repair, elbow replacement, ankle arthroplasty, knee replacement, circumcision, open reduction internal fixation of ankle, hardware removal from ankle, cholecystectomy, and lengthening of the Achilles tendon.

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