About SEVENFACT - Sevenfact

The SEVENFACT difference

SEVENFACT is the first inhibitor bypassing agent approved in the US in over 20 years^1,2

A recombinant FVIIa, SEVENFACT differs molecularly from other available bypassing agents

	Difference in in vitro receptor binding affinity and glycosylation³
	Difference in molecular weight³
	Difference in clinical dosing³

A recombinant FVIIa, SEVENFACT differs molecularly from other currently available bypassing agents³

Phase 1b dose-ranging study investigated a range of doses to confirm dose-dependent thrombin generation using an in vitro assay⁴

	Dose-dependency was seen in peak thrombin generation when measured from 5 minutes to 24 hours⁴
	The highest thrombin generation was observed with the 225 μg/kg dose⁴

TGAp. TGA with platelets to estimate in vivo thrombin generation (mean ± SD)

The impact of inhibitors

Living with an inhibitor is unpredictable

Controlling bleeds quickly is of critical concern

Delayed time to bleed resolution can lead to:

	More blood in the joint and the hematoma⁵
	Long-term joint damage^6-8

	Higher total costs⁶
	More doses being required to stop the bleeding⁵

As the first inhibitor bypassing treatment approved in more than 20 years, SEVENFACT meets the ongoing need for more treatment options^1,2

Find out how SEVENFACT is dosed to achieve your treatment goals¹

VIEW DOSING

Explore the manufacturing standards and purification process of SEVENFACT¹

FIND OUT MORE

NEXT: The rapid, predictable, and reliable efficacy of SEVENFACT

References:

SEVENFACT [Prescribing Information]. HEMA Biologics; 2022.
NovoSeven [Prescribing Information]. Novo Nordisk; 2022.
Biron-Andreani C, Schved J-F. Eptacog beta: a novel recombinant human factor VIIa for the treatment of hemophilia A and B with inhibitors. Expert Rev Hematol. 2019;12(1):21-28.
Ducore J, Lawrence J, Simpson M, et al. Safety and dose-dependency of eptacog beta (activated) in a dose escalation study of non-bleeding congenital hemophilia A or B patients, with or without inhibitors. Haemophilia. 2017;1-8
Salaj P, Brabec P, Penka M, et al. Effect of rFVIIa dose and time to treatment on patients with haemophilia and inhibitors: analysis of HemoRec registry data from the Czech Republic. Haemophilia. 2009;15:752-759.
Kavakli K, Yesilipek A, Antmen B, et al. The value of early treatment in patients with haemophilia and inhibitors. Haemophilia. 2010;16:487-494.
Morfini M. Rapid rFVIIa enhanced on-demand dosing in haemophilia inhibitor patients. Eur J Haematol. 2015;96:111-118.
Gomez K, Klamroth R, Mahlangu J, et al. Key issues in inhibitor management in patients with haemophilia. Blood Transfus. 2014;12(suppl1):s319-s329.

Important Safety Information

*Indications and Usage

SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is indicated 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.

SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.

WARNING: THROMBOSIS

Serious arterial and venous thrombotic events may occur following administration of SEVENFACT.
Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive SEVENFACT.
Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Contraindications

SEVENFACT is contraindicated in patients with known allergy to rabbits or rabbit protein, or severe hypersensitivity reaction to SEVENFACT or any of its components.

Warnings and Precautions

There is limited information about the safety of SEVENFACT in patients with a history of arterial or venous thromboembolic disease, because such patients were excluded from SEVENFACT trials. Serious arterial and venous thrombotic reactions can occur with SEVENFACT and have been reported in clinical trials and postmarketing surveillance with a similar class of products.

The following patients may have an increased risk of thromboembolic events with use of SEVENFACT:

History of concomitant treatment with aPCC/PCC (activated or non-activated prothrombin complex) or other hemostatic agents.
History of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolism.

Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT. Should symptoms occur, patients should discontinue SEVENFACT and seek appropriate medical intervention. Patients with known hypersensitivity to casein may be at higher risk of hypersensitivity reaction.

Adverse Reactions

The most common adverse reactions reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.

Drug Interactions

Clinical experience with pharmacologic use of FVIIa-containing products indicates an elevated risk of serious thrombotic events when used simultaneously with activated prothrombin complex concentrates.

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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