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, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, and in adults with acquired hemophilia.
Dosing calculator for bleeding episodes
Use this dosing calculator to determine the recommended NovoSeven® RT dose for your patient, plus the number of vials required.
As a reminder, for US health care professionals only.
NovoSeven® RT
dosing tools
NovoSeven® RT is proven effective for bleed resolution and surgery for 5 indications: CHAwI or CHBwI, AH, CFVIId, and GT with refractoriness to platelets.1 Use these tools to identify the recommended dose for bleeds and perioperative management for your patients in each indication.
Recommended dosing for treatment of bleeding episodes and surgery1
Use our Quick Reference Dosing Guide to get an overview of recommended doses for bleeding episodes and perioperative management for each approved indication.
For detailed dosing information, please see the Prescribing Information.
Congenital Hemophilia A or B with Inhibitors
(for bleeding episodes)a
Before hemostasis is achieved
90 mcg/kg every 2 hours
adjustable based on severity of bleeding, until hemostasis is achieved, or until the treatment has been judged to be inadequate
After hemostasis is achieved
90 mcg/kg every 3-6 hours for severe bleeds
after hemostasis is achieved to maintain the hemostatic plug
The appropriate duration of post-hemostatic dosing has not been studied
Acquired Hemophilia
(for bleeding episodes)a
70-90 mcg/kg every 2-3 hours until hemostasis is achieved
Congenital Factor VII Deficiency
(for bleeding episodes)a
15-30 mcg/kg every 4-6 hours until hemostasis is achieved
Effective treatment has been achieved with doses as low as 10 micrograms per kg body weight
Adjust dose and frequency of injections to each individual patient
Glanzmann’s Thrombasthenia
With refractoriness to platelet transfusions, with or without antibodies to platelets
(for bleeding episodes)a
90 mcg/kg every 2-6 hours in severe bleeding episodes requiring systemic hemostatic therapy until hemostasis is achieved
Platelet transfusions are the primary treatment in patients with Glanzmann’s thrombasthenia without refractoriness to platelets or in patients without platelet-specific antibodies
CHwI=congenital hemophilia with inhibitors; AH=acquired hemophilia; CFVIId=congenital factor VII deficiency; GT=Glanzmann’s thrombasthenia
aThe minimum effective dose has not been determined.
For detailed dosing information, please see the Prescribing Information.
Congenital Hemophilia A or B with Inhibitors
(for perioperative management)
Minor
Initial:
90 mcg/kg immediately before surgery
repeat every 2 hours for the duration of the surgery
Post surgical:
90 mcg/kg every 2 hours after surgery for 48 hours then every 2-6 hours until healing occurs
Major
Initial:
90 mcg/kg immediately before surgery
repeat every 2 hours for the duration of the surgery
Post surgical:
90 mcg/kg every 2 hours after surgery for 5 days then every 4 hours or by continuous infusion at 50 mcg/kg/hr until healing occurs
Additional bolus doses can be given
Acquired Hemophilia
(for perioperative management)
Minor or Major
70-90 mcg/kg immediately before surgery and every 2-3 hours for the duration of surgery and until hemostasis is achieveda
Congenital Factor VII Deficiency
(for perioperative management)
Minor or Major
15-30 mcg/kg immediately before surgery and every 4-6 hours for the duration of surgery and until hemostasis is achieveda
Adjust dose and frequency of injections to each individual patient
Doses as low as 10 micrograms per kg body weight can be effective
Glanzmann’s Thrombasthenia
With refractoriness to platelet transfusions, with or without antibodies to platelets
(for perioperative management)
Minor or Major
Initial:
90 mcg/kg immediately before surgery and every 2 hours for the duration of the procedurea
Post surgical:
90 mcg/kg every 2-6 hours to prevent post-operative bleedinga
Higher doses of 100-140 micrograms per kg can be used for surgical patients who have clinical refractoriness with or without platelet-specific antibodies
CHwI=congenital hemophilia with inhibitors; AH=acquired hemophilia; CFVIId=congenital factor VII deficiency; GT=Glanzmann’s thrombasthenia
aThe minimum effective dose has not been determined.
Dosing Calculator for Bleeding Episodes
Use this dosing calculator to determine the recommended NovoSeven® RT dose for your patient, plus the number of vials required.
As a reminder, for US health care professionals only.
For detailed dosing information including perioperative management, please view the Prescribing Information.
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Important Safety Information for NovoSeven® RT
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
- 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 NovoSeven® RT Prescribing Information, including Boxed Warning.
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 for NovoSeven® RT
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
Important Safety Information for NovoSeven® RT
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
- 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 NovoSeven® RT Prescribing Information, including Boxed Warning.
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
Reference
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc.