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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

Effective bleed control with proven trial results and real-world experience.

Efficacy seen in Lusher et al.2,a,b

Efficacy seen in adept™2.3,c

  • One of the largest clinical trials conducted in patients with CHwI
  • Consistent efficacy seen in joint, target joint, mucocutaneous, muscle, and other bleeding episodes
  • 98% effective bleed control in patients ≤18 years, based on real-world experience4

 

  • One of the largest clinical trials conducted in patients with CHwI
  • Consistent efficacy seen in joint, target joint, mucocutaneous, muscle, and other bleeding episodes
  • 98% effective bleed control in patients ≤18 years, based on real-world experience4

 

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

5 hr pie chart

NovoSeven® RT achieved maximum activity within 5-10 minutes of infusion5,f,g


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.
fData from a randomized, double-blind trial of healthy subjects (N=22) who received 1 intravenous bolus injection each of NovoSeven® RT and NovoSeven®. Both bolus injections were 90 mcg/kg and occurred 2 to 3 weeks apart at consecutive visits. While the comparison is not shown for FVIIa, activity for NovoSeven® RT was the bioequivalent range of that for NovoSeven® during this period.5
g
FVIIa activity IU/mL.

 

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,h
 

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

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

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

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

Tab Safety Profile

NovoSeven® RT has a well-established safety profile.

NovoSeven® RT is the only recombinant bypassing agent not made from human serum or human proteins. Recombinant manufacturing minimizes the possibility of viral contamination.1,6

Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.1

See Important Safety Information.

Thrombotic adverse reactions in clinical trials occurred in 0.2% of bleeding episodes in patients with congenital hemophilia with inhibitors.1,6,j

jIn patients with congenital hemophilia.

MASAC recommends rFVIIa as a first option to treat acute bleeding episodes in patients on emicizumab—aPCC should be avoided if possible.7

Phase 3 clinical trials provide additional support for resolving bleeds in CHAwI patients on emicizumab.


NovoSeven® RT was used safely in 61 patients treating with emicizumab in 3 separate pivotal trials: HAVEN 1, 2, and 4.8,9,k

  • 180 bleeds were treated with NovoSeven® RT only in HAVEN 1
  • No SAEs, TMAs, or TEs were observed with use of NovoSeven® RT alone in HAVEN 1, 2, and 4
  • No new or unexpected safety concerns were observed with use of NovoSeven® RT in conjunction with emicizumab
  • Two cases of TMA occurred in patients treating with emicizumab while receiving FEIBA® and NovoSeven® RT. Simultaneous use of NovoSeven® RT and FEIBA should be avoided

MASAC=Medical and Scientific Advisory Council; rFVIIa=recombinant activated factor VII; SAE=serious adverse event; TMA=thrombotic microangiopathy; TE=thrombotic event.
kThe analysis included bleeding episodes in the HAVEN 1, HAVEN 2, and HAVEN 4 clinical trials for which patients with CHAwI on emicizumab prophylaxis (at the labeled dose) used rFVIIa. Initial individual dosing with rFVIIa, dosing intervals, and cumulative dosing were evaluated. All adverse events reported in each of the 3 trials, including available narratives, were assessed. For a complete description of MASAC recommendations, please see full guidelines.

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,l

lPrior 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.

Thermometer displaying 77˚F

Quick reconstitution can save them time.

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


m
Compared with reconstitution using histidine vials.

Tab Infusion Time

Compare NovoSeven® RT with FEIBA: Rapid infusion with less volume.1

Up to 18x faster to infuse than FEIBA 1,10,n,o,p

16x less infusion volume than FEIBA 1,10,n,o,p

Vial of NovoSeven® RT (Coagulation Factor VIIa [Recombinant])
Vials of pd-aPCC

nIn patients with hemophilia A or B with inhibitors.
oIndividual doses for a joint bleed are compared and based on an 88-kg (194-lb) person.
pPatients are cautioned that the maximum injection or infusion rate must not exceed 2 U/kg of body weight.

Tab Perioperative Use

Effectiveness of NovoSeven® RT in surgeries and procedures.

NovoSeven® RT is the only bypassing agent approved for continuous infusion and with controlled clinical trials supporting its efficacy during and after surgery in patients with CHwI.1,11,q,r


Results of a prospective, randomized trial show the effectiveness of NovoSeven® RT:
 

Percentage of patients with adequate hemostasis:6


Adapted from Shapiro et al.11,r

Male sitting on hospital bed


qData from a prospective, randomized trial comparing 35 mcg/kg with 90 mcg/kg rFVIIa, each given every 2 hours intraoperatively or as needed and every 2 hours in the first 48 hours, then every 2 to 6 hours through day 5. Beyond day 5, patients were treated with open-label 90 mcg/kg until discharge of the investigator. A total of 29 patients underwent 11 major and 18 minor procedures. Data shown are from the 90 mcg/kg group.11
r
In patients with hemophilia A or B with inhibitors. Actual length of postoperative period may vary.

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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

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 Prescribing Information

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  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. Neufeld EJ, Saxena K, Kessler CM, et al. Dosing, efficacy, and safety of recombinant factor VIIa (rFVIIa) in pediatric versus adult patients: the experience of the Hemostasis and Thrombosis Research Society (HTRS) Registry (2004-2008). Pediatr Blood Cancer. 2013;60(7):1178-1183.
  5. 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.
  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.
  7. National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (hemlibra®) for hemophilia a with and without inhibitors. MASAC Document #255. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations. Accessed December 2018.
  8. Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818 and appendix.
  9. 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.
  10. FEIBA [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
  11. Shapiro AD, Gilchrist GS, Hoots WK, et al. Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998;80(5):773-778.