Congenital hemophilia A or B with inhibitors.

NovoSeven® RT is the only recombinant bypassing agent for congenital hemophilia with inhibitors.1

Congenital hemophilia A or B with inhibitors.

NovoSeven® RT is the only recombinant bypassing agent for congenital hemophilia with inhibitors.1

Efficacy

Clinically proven efficacy.

Lusher et al.2,a,b

A randomized, double-blind study of patients with hemophilia A and B with and without inhibitors.

adept™2 study.3,c

One of the largest clinical trials conducted in patients with hemophilia with inhibitors.

Your patients expect fast resolution of joint bleeds. NovoSeven® RT controls bleeds in as few as 5 hours with a median of 2 doses.2,4,b,e

5 hours


a
Results shown are from the 70 mcg/kg group.
b
Data from a randomized, double-blind parallel-group, multicenter study of patients with hemophilia A and B with and without an inhibitor (n=84). Patients were given NovoSeven® 35 or 70 mcg/kg at dosing intervals of 2 to 3 hours. Efficacy reflects the number of patients reporting excellent, effective, or partially effective results. Response was rated as “excellent” if patient demonstrated definitive relief of pain/tenderness and/or if there was a measurable decrease in the size of the bleed (or arrest of bleeding) in 8 hours or less. An “effective” response was measured by any of these 3 events occurring from 8 to 14 hours; a “partially effective” response either occurred after 14 hours or indicated detectable relief of pain/tenderness or decrease in size of the hemorrhage or if the bleeding had slowed.2
c
Data from an international, multicenter, randomized, double-blind, active controlled, confirmatory phase 3 trial of patients with hemophilia A or B with inhibitors (n=69). Primarily carried out in the home setting, all bleeds were treated, and each bleeding episode was randomized (3:2) to infuse either 1 to 3 doses of vatreptacog alfa (340 bleeding episodes, 80 mcg/kg) or 1 to 3 doses of NovoSeven® RT (227 bleeding episodes; 90 mcg/kg) when bleed symptoms were recognized, preferably within 2 hours of onset. Primary efficacy endpoint indicated effective bleed control defined as no additional hemostatic medication (other than the original medication) given within 12 hours after the initial dose.3
d
In patients with hemophilia A or B with inhibitors.2
e
Calculation of 5 hours is based on 2.2 doses at 2-hour interval.

 

tab Tailored Dosing

Adjustable dosing.

Based on the severity of bleeding for each individual patient, both the recommended dose of 90 mcg/kg and dosing interval can be adjusted until hemostasis is achieved.1,f
 

fIn patients with hemophilia A or B with inhibitors.2
g
The minimum effective dose has not been determined.

Dosing recommendation for congenital hemophilia A or B with inhibitors.1,g

BEFORE HEMOSTASIS IS ACHIEVED

90 mcg/kg

every 2 hours

adjustable based on severity of bleeding until hemostasis is achieved

AFTER HEMOSTASIS IS ACHIEVED

90 mcg/kg

every 3-6 hours

after hemostasis is achieved for severe bleeds

fIn patients with hemophilia A or B with inhibitors.2
g
The minimum effective dose has not been determined.

Tab Infusion Time

Compare NovoSeven® RT with pd-aPCC for infusion time.1

Up to 18x faster to infuse than pd-aPCC 1,5,h,i

16x less infusion volume than pd-aPCC 1,5,h,i

hIn patients with hemophilia A or B with inhibitors.
iIndividual doses for a joint bleed are compared and based on an 88-kg (194-lb) person.
jAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

Tab Safety Profile

NovoSeven® RT gives him the safety he deserves.

NovoSeven® RT is the only recombinant bypassing agent not made from human plasma or human proteins.1 Recombinant manufacturing minimizes the possibility of viral contamination, while studies show a 0.2% rate of thrombotic adverse events in patients with congenital hemophilia with inhibitors.1,6

Tab 3-step Reconstitution

Room temperature stable for patients on the go.

NovoSeven® RT offers stability up to 77°F, for rapid access to treatment.1,k

kPrior 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.

Quick reconstitution can save him time.

Every vial comes with a prefilled syringe, meaning no extra steps to fill a syringe with diluent.1,l


l
Compared with reconstitution using histidine vials.

Approved for surgical use and

procedures in patients with

congenital hemophilia with inhibitors.


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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.  

 

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  2. 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.
  3. Lentz SR, Ehrenforth S, Abdul Karim F, et al; adept™2 investigators. Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa. J Thromb Haemost. 2014;12(8):1244-1253.
  4. Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulation. Haemophilia. 2007;13(5): 527-532.
  5. FEIBA [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2013.
  6. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #250. New York, NY: National Hemophilia Foundation; 2017.