Important Safety Information    Prescribing Information

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.

[Rep Name]

[Phone]

[Email Address]

Hello, [Designation] [First name] [Last name].

I would love a chance to meet and discuss prescribing NovoSeven^® RT for your appropriate patients, the most trusted and experienced rFVIIa.¹

What makes NovoSeven^® RT a good choice for hospitals? NovoSeven^® RT is the one and only rFVIIa that offers:

^aIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.³

Selected Important Safety Information

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

Hope to hear from you soon,

[Rep Name]

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.

Reference:

1. Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125:S4-S6.
2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 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.
4. Lusher JM, Roberts HR, Davignon G, et al; and rFVIIa Study Group. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. Haemophilia. 1998;4(6):790-798.
5. Lusher J, Ingerslev J, Roberts H, et al. Clinical experience with recombinant FVIIa. Blood Coagulation and Fibrinolysis. 1998;9:119-128.