Novo Nordisk

Emicizumab patients with inhibitors have unique needs.

NovoSeven^® RT is indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia.

vial of NovoSeven® RT and syringe of histidine for reconstitution

Do you have the right bypassing
agent in stock for acute bleeds?

Time is of the essence when hemophilia patients, including those with inhibitors taking emicizumab, come to the emergency department (ED) with acute bleeds. The Medical and Scientific Advisory Council (MASAC) recommends having factor replacement therapy available within one hour of the patient’s arrival.¹

Per MASAC, treat bleeds:

	•	BEFORE receiving results of lab tests.¹
	•	BEFORE performing diagnostic studies (e.g., X-rays, CT scans).¹
	•	BEFORE any necessary invasive procedures or surgeries.^1,a

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^aFactor replacement therapy or bypass therapy to 100% must be administered in the ED prior to the planned procedure or surgery.¹

Keep scrolling to see which therapy MASAC recommends.

Selected Important Safety Information

WARNING: THROMBOSIS

•

Serious arterial and venous thrombotic events following administration of NovoSeven^® RT have been reported

•

Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven^® RT

•

Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis

Warnings and Precautions

•

Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance

•

Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events

Please click here or scroll below for additional Important Safety Information.

In emergencies,
use a bypassing agent in
patients with CHAwI.

While emicizumab is effective in preventing bleeds in CHAwI patients, it is ineffective in treating acute bleeding events.¹ Providers should make rFVIIa their first option for treatment and avoid treating with FEIBA^® if possible.^2,b

Note: FEIBA^® may cause thrombosis or thrombotic microangiopathy in patients taking emicizumab.¹ The safety of using rFVIIa in conjunction with emicizumab was demonstrated in 3 separate pivotal trials: HAVEN1, 2, and 4.^3,c

Explore rFVIIa Safety Data

CHAwI = congenital hemophilia A with inhibitors

^bFor a complete description of MASAC recommendations, please see full guidelines.²

^cThe post-hoc analysis included bleeding episodes in the HAVEN1, HAVEN2, and HAVEN4 clinical trials for which patients with congenital hemophilia A with inhibitors on emicizumab prophylaxis (at the labeled dose) used rFVIIa. Initial individual dosing with rFVIIa, dosing intervals, and cumulative dosing were evaluated. All adverse events reported in each of the 3 trials, including available narratives, were assessed.³

Indications and Usage

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:

•

Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets

•

Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia

Important Safety Information (cont’d)

Warnings and Precautions

•

Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven^® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur

•

Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed

•

Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis

Adverse Reactions

•

The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven^® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia

Drug Interactions

•

Thrombosis may occur if NovoSeven^® RT is administered concomitantly with Coagulation Factor XIII

Please click here for Prescribing Information.

1.	National Hemophilia Foundation. Guidelines for emergency department management of individuals with hemophilia and other bleeding disorders, #257. New York, NY: National Hemophilia Foundation; 2019.
2.	National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (hemlibra^®) for hemophilia a with and without inhibitors. MASAC Document #258. Accessed June 2020.
3.	Levy GG, Asikanius E, Kuebler P, et al. Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program. J Thromb Haemost. 2019; 17(9):1470-1477.

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