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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—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 inhibitors

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 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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Important Safety Information

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

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.

What is SEVENFACT?

SEVENFACT is an injectable medicine used for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors.

Injecting medicines requires special training; do not attempt to self-infuse unless you have been taught how by your healthcare provider.

Who should not use SEVENFACT (coagulation factor VIIa)?

You should not use SEVENFACT if you are allergic to rabbits, or if you have known allergies to SEVENFACT or any of its components. Seek immediate medical help if you experience hives, itching, rash, difficulty breathing with cough or wheezing, swelling around the mouth and throat, tightness of the chest, dizziness or fainting, or low blood pressure after taking SEVENFACT.

Tell your healthcare provider prior to using SEVENFACT if you have begun treatment of a bleeding episode with another bypassing agent.

What should I tell my healthcare provider before I use SEVENFACT?

Tell your healthcare provider if you are pregnant, are nursing, or plan to become pregnant; if you have had prior blood clots, heart disease or heart failure, abnormal heart rhythms, prior pulmonary clots, or heart surgery; or if you have or have had any other medical conditions.

What are the possible side effects of SEVENFACT?

The most common adverse reactions for SEVENFACT are headache, dizziness, infusion-site discomfort, infusion-site hematoma, and infusion-related reaction and fever.

Seek immediate medical help if you have signs of a blood clot or an allergic reaction.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact HEMA Biologics at 1-855-718-4362. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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