Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore rare renal disorders
Explore hormone replacement therapy
Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
NovoSeven® RT (coagulation Factor VIIa, recombinant) logo

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.

Prescribing Information
Important Safety Information | Patient Site

Is your hospital ready for bleeds when they happen?

In situations where a patient does not bring their own clotting factor concentrate, MASAC recommends emergency departments have ready access to it within 1 hour upon a patient’s arrival.1

Is your hospital ready for bleeds when they happen?

In situations where a patient does not bring their own clotting factor concentrate, MASAC recommends emergency departments have ready access to it within 1 hour upon a patient’s arrival.1

Health care professional

Actor portrayal

NovoSeven® RT helps prepare your hospital for the widest range of bleeding disordersa

Product comparison chart

Indications

NovoSeven® RT2,b

FEIBA®3,c

OBIZUR®4,d

SEVENFACT®5,e,f

Congenital hemophilia A with inhibitors

Red triangle and blue circle
Red triangle and blue circle
Red triangle

Congenital hemophilia B with inhibitors

Red triangle and blue circle
Red triangle and blue circle
Red triangle

Acquired hemophiliag

Red triangle and blue circle
Red triangle

Congenital factor VII deficiency

Red triangle and blue circle

Glanzmann's thrombasthenia

with refractoriness to platelet transfusions, with or without antibodies to platelets

Red triangle and blue circle
Red triangle

= bleed treatment;

Blue circle

= perioperative management


Disclaimer: This chart is not intended to compare efficacy or safety. 
aAs compared to FEIBA, Obizur and SEVENFACT.
bNovoSeven® RT is a recombinant FVIIa.
cFEIBA is an activated prothrombin complex concentrate (aPCC).
dOBIZUR is a porcine sequence recombinant FVIII.
eSEVENFACT is a recombinant FVIIa.
fSEVENFACT is only indicated for adults and adolescents (12 years and older).
gAdults with acquired hemophilia.

NovoSeven® RT offers features to support hospital use.2

NovoSeven® RT packaging
  • Low-volume dosing and compact packaging to help maximize space
  • Ability to administer via continuous infusion for perioperative management
  • Room temperature storage up to 77˚Fg
  • Available in 1-mg, 2-mg, 5-mg, and 8-mg vials
  • Everything needed for reconstitution is in 1 box
  • Each vial comes with a prefilled syringe, meaning no extra steps to fill a syringe with diluenth

gPrior to reconstitution, store NovoSeven® RT powder and histidine diluent between 36-77˚F. After reconstitution, store NovoSeven® RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store in syringes.
hCompared with reconstitution using histidine vials.

NovoSeven® RT vials

Need dosing information?

HCP

Need resources for emergency medicine?

Selected 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

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

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.

References

  1. National Hemophilia Foundation. MASAC guidelines for emergency department management of individuals with hemophilia and other bleeding disorders, #257. 2019.
  2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  3. FEIBA [package insert]. Westlake Village, CA: Baxalta US Inc; 2020.
  4. Obizur [package insert]. Westlake Village, CA: Baxalta US Inc; 2021.
  5. SEVENFACT [Prescribing Information]. Louisville, KY: HEMA Biologics; 2020.