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SEVENFACT Efficacy

SEVENFACT 225 IDR*: Quick and lasting bleed control with just one dose

*IDR=initial dosing regimen.
†225 mcg/kg initial dosing regimen in the clinical trial.

SEVENFACT 225 achieved control in 84% of bleeding episodes at 9 hours

SEVENFACT 225—for mild/moderate bleeds, starting dose of 225 mcg/kg, followed, if necessary, 9 hours later by a 75 mcg/kg dose every 3 hours as needed

SEVENFACT 75 IDR: Dependable bleed control

SEVENFACT 75 IDR: Starting dose of 75 mcg/kg, followed by 75 mcg/kg every 3 hours as needed

96.7% of bleeding episodes were resolved at 24 hours

SUCCESSFUL PAIN RELIEF AT 12 HOURS WAS REPORTED BY THE MAJORITY OF PATIENTS IN BOTH DOSES

A proven safety profile

In the SEVENFACT clinical trial

No neutralizing antibodies

No allergic reactions

No thromboembolic events

What is the most important safety information I should know about SEVENFACT?

The most serious possible side effect of SEVENFACT is abnormal clotting involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

You should know the signs of abnormal clotting and seek medical help immediately if they occur.
Signs of clotting in places other than your site of bleeding can include new onset of swelling and pain in limbs, new onset of chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech.

Adverse event occurrence was similar between the SEVENFACT 225 and SEVENFACT 75 dose regimens

Adverse events in SEVENFACT clinical trials (N=42)§

Adverse event

Number of adverse reactions

Infusion-site discomfort

4

Infusion-site bruising

2

Dizziness

2

Infusion-related reaction

1

Headache

1

Increased body temperature

1

§In Study 1 and Study 2.

SEVENFACT purification and manufacturing

SEVENFACT is manufactured to high quality and purity for your safety and peace of mind.

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

Goes through an extensive purification process before final production

Predictable||, reliable bleed control with just a SINGLE DOSE of SEVENFACT 225

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||As seen in the clinical trial.

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