SEVENFACT efficacy and safety

The efficacy and safety of SEVENFACT were demonstrated in the PERSEPT 1 clinical trial1,2

PERSEPT 1 Clinical Trial—efficacy and safety studied for the treatment and control of bleeding episodes in patients with moderate or severe hemophilia A or B with inhibitors1,2

Prospective, randomized, open-label, crossover study of two initial dose regimens (IDRs) in 27 patients ≥12 years old with hemophilia A or B with inhibitors who experienced 468 bleeding episodes over the course of the study period*1,2

*PERSEPT=Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trial

225 μg/kg initial dosing regimen in the clinical trial.
75 μg/kg initial dosing regimen in the clinical trial.
§Three of the 468 bleeds were considered life- and limb-threatening and were not included in this primary analysis.2

Patients averaged about 13 bleeds in six months prior to study entry2

A variety of bleeds were studied in the clinical trial2

~30% of bleeds were in target joints2

Bleeds included: knee, elbow/ankle, foot, shoulder, wrist/hand, hip, nose, mouth, and soft tissue/muscle2

Primary efficacy endpoint: The successful treatment of mild or moderate bleeding episodes 12 hours after initial SEVENFACT dosing1

The primary efficacy endpoint included all of the following1:

Patient assess of “Good” or “Excellent” response using a 4-point hemostatic efficacy scale at 12 hours

No further treatment with SEVENFACT or blood products at or beyond 12 hours

No administration of other hemostatic treatments

No increase in pain beyond 12 hours

Successful treatment—Bleeds had to be resolved at 12 hours, with no subsequent increase in pain, and not require any subsequent alternative treatment through 24 hours

SEVENFACT results

SEVENFACT 225||:
Rapid, predictable, and reliable bleed control2

||225 μg/kg initial dose, followed, if necessary, 9 hours later by a 75 μg/kg dose every 3 hours until bleed control1
As seen in the clinical trial.

Rapid effect: 3 hour

At 3 hours, 84% of mild/moderate bleeding episodes were controlled with a single dose#2

Predictable response: 84%

At 9 hours, 84% of mild/moderate bleeding episodes treated achieved bleed control after a single dose2

Reliable control: 99.5%

At 24 hours, 99.5% of mild/moderate bleeding episodes were resolved2
— At 12 hours, hemostatic efficacy with SEVENFACT 225 was even better than with SEVENFACT 751

Convenient home use: 98%

98% of bleeding episodes were self-treated at home1

#Success proportion that includes data from 158/213 bleeding episodes (excludes missing data).

SEVENFACT 75**: Confidence in clinical hemostasis

The majority of bleeding episodes were successfully treated at 12 hours1

**SEVENFACT 75: initial 75 μg/kg dose. Subsequent 75 μg/kg doses every 3 hours as needed until bleed control1

96.7% of mild/moderate bleeding episodes treated with SEVENFACT 75 were resolved at 24 hours2

98% of bleeding episodes were
treated at home1

Demonstrated safety profile1

In a clinical trial of SEVENFACT with 27 patients and 468 bleeding episodes, both initial dose regimens were well tolerated.1,2

Patients with a history of thromboembolic events were excluded from the trial.1
Neutralizing antibodies may occur with SEVENFACT.1

Adverse reactions in SEVENFACT clinical trials (N=42)††1

Adverse event

Number of adverse reactions

Infusion-site discomfort

4

Infusion-site hematoma

2

Dizziness

2

Infusion-related reaction

1

Headache

1

Increased body temperature

1

††In Study 1 and Study 2.

In the PERSEPT 1 clinical trial of 27 subjects

No neutralizing antibodies1

No allergic reactions1

No thromboembolic events1

Hypersensitivity reactions

Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT, though none have been reported1

Patients with known IgE-based hypersensitivity to rabbit proteins or casein may be at higher risk of hypersensitivity reactions1

No immunogenic reactions related to SEVENFACT were reported; however, neutralizing antibodies may occur with the use of SEVENFACT.1

No thromboembolic events were reported; patients with a history of thromboembolic events were excluded from the trials.1

Manufactured to high quality and purity for your patients’ safety and peace of mind

SEVENFACT is a recombinant treatment for inhibitors and is not derived from human blood1

Goes through an extensive purification process before final production

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References:

  1. SEVENFACT [Prescribing Information]. HEMA Biologics; 2020.
  2. Data on file. HEMA Biologics.