Preparing a dose is fast with MixPro®.

NovoSeven® RT provides a prefilled syringe with every dose.

Preparing a dose is as easy as attach, twist, and mix.

Refer to Instructions for Use for complete information 

Reconstitution Video

Watch our patient-friendly video to see how to reconstitute a dose with MixPro®.

Room temperature stability gives patients rapid access to treatment.

  • Room temperature stable up to 77°F1,a
  • Available in 1-mg, 2-mg, 5-mg, and 8-mg vials1 
  • Everything they need to reconstitute is in 1 small box
  • Each vial comes with a prefilled syringe, meaning no extra steps to fill a syringe with diluent1,b

aPrior 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.
b
Compared with reconstitution using histidine vials.

aPrior 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.
b
Compared with reconstitution using histidine vials.

Administering NovoSeven® RT.

Prior to administration

  • Inspect the reconstituted NovoSeven® RT visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed
  • Do not freeze reconstituted NovoSeven® RT or store it in syringes.
  • Administer within 3 hours after reconstitution
  • Do not mix with other infusion solutions
  • Discard any unused solution

Please note, this is not the complete NovoSeven® RT Instructions for Use. Please refer to the Instructions for Use provided with the Prescribing Information.

Administration

Administer NovoSeven® RT using the following procedures:

  1. Administer as a slow bolus injection over 2 to 5 minutes, depending on the dose administered
  2. If line needs to be flushed before or after NovoSeven® RT administration, use 0.9% Sodium Chloride Injection, USP
  3. Discard any unused reconstituted NovoSeven® RT after 3 hours

Please see the Prescribing Information for further details.

Caution:

  • The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector
  • Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave®/MicroClave®, InVision-Plus®, InVision-Plus CS®, InVision-Plus® Junior®, Bionector®), and their use can damage the connector and affect administration. To administer product through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe
  • If you have encountered any problems with attaching the pre-filled histidine diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (877) 668-6777
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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.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for:

  • Treatment of bleeding episodes and peri-operative 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 peri-operative 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.
  • Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease, post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates).
  • Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven® RT. Administer only if clearly needed in patients with known hypersensitivity to NovoSeven® RT, any of its components, or mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT and administer appropriate treatment.
  • 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. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.