For the treatment of bleeding episodes in people* with hemophilia A or B with inhibitors

HE’S READY TO MOVE ON

SEVENFACT

The first inhibitor bypassing agent approved in the US in over 20 years^1,2
Differs molecularly from other available rFVIIa³

For the treatment of bleeding episodes in people* with hemophilia A or B with inhibitors

HE’S READY TO MOVE ON

SEVENFACT

The first inhibitor bypassing agent approved in the US in over 20 years^1,2
Differs molecularly from the other available rFVIIa³

SEVENFACT Patient Videos

Learn how SEVENFACT has helped make patients' lives more predictable.

Living with an inhibitor
is unpredictable^4-7

Controlling bleeds quickly is of critical concern

Rapid, predictable, and reliable relief⁸

84% of 213 mild/moderate bleeding events achieved sustained bleed control after just one dose of SEVENFACT 225^†8

^†225 μg/kg initial dose regimen in the clinical trial.

Dose to achieve your treatment goals for mild/moderate bleeds¹

SEVENFACT 225: Starting dose of 225 μg/kg, followed, if necessary, 9 hours later by a 75 μg/kg dose every 3 hours until bleed control or 24-hour timepoint^‡

^‡Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration 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.
Salaj PO, 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. 2016;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.
Data on file. HEMA Biologics.

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.

HE’S READY TO MOVE ON

SEVENFACT

HE’S READY TO MOVE ON

SEVENFACT

SEVENFACT Patient Videos

Living with an inhibitor is unpredictable4-7

Rapid, predictable, and reliable relief 8

Dose to achieve your treatment goals for mild/moderate bleeds1

Important Safety Information

*Indications and Usage

WARNING: THROMBOSIS

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

Living with an inhibitor
is unpredictable^4-7

Rapid, predictable, and reliable relief⁸

Dose to achieve your treatment goals for mild/moderate bleeds¹