Dosing SEVENFACT

See how to use SEVENFACT

Convenient to store, convenient to use

Convenient to infuse

SEVENFACT should be IV-infused in 2 minutes or less

Convenient to use

Once reconstituted, you have 4 hours to infuse SEVENFACT*

*Do not use if more than 4 hours have passed since reconstitution

Easy to store

Prior to reconstitution, the SEVENFACT kit should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), protected from light in the product package. Do not freeze
After reconstitution, SEVENFACT should be stored at room temperature but can be stored between 36°F to 86°F (2°C to 30°C), for up to 4 hours. Do not freeze or store in syringes

How to mix SEVENFACT

A kit that helps you through the mixing process

Product package includes:

	Vial containing SEVENFACT
	Prefilled reconstitution syringe
	Vial adapter
	Patient Instructions for Use

Pharmacy will provide an infusion syringe and other infusion supplies

Supplied in two convenient single-use vial sizes, each with a prefilled syringe

Withdrawing reconstituted SEVENFACT from vial

Withdraw the liquid drug from the vial, using a syringe provided by a specialty pharmacy that is large enough to hold the prescribed dose. The Luer-Lok™ tip is designed to provide a secure connection that avoids needle disengagement or medication leakage.

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See how to mix SEVENFACT

Interested in seeing how to mix your SEVENFACT? Watch a step-by-step demonstration here:

For instructions on the use of SEVENFACT, please take a few moments to view this demo. This video can help you by providing an overview of the SEVENFACT infusion process.

Studies of SEVENFACT showed the optimal dose to control bleeds quickly with fewer doses^†

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^†SEVENFACT 225 mcg/kg initial dose regimen (IDR) compared to SEVENFACT 75 mcg/kg IDR in the PERSEPT 1 clinical trial.

The rapid, predictable, and reliable control of SEVENFACT 225^‡§

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^‡As seen in the clinical trial.
^§225 mcg/kg initial dosing regimen in the clinical trial.

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Important Safety Information

What is the most important 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.

*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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