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 see Brief Summary of Prescribing Information on the following pages .
References : 1 . Hedner U . History of rFVIIa therapy . Thromb Res . 2010 ; 125 ( suppl 1 ): S4 – S6 . 2 . NovoSeven RT [ package insert ]. Plainsboro , NJ : Novo Nordisk Inc ; 2015 . 3 . 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 . 4 . Abshire T , Kenet G . Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors . Haemophilia . 2008 ; 14 ( 5 ): 898-902 .
Novo Nordisk Inc ., 800 Scudders Mill Road , Plainsboro , New Jersey 08536 U . S . A .
NovoSeven ® is a registered trademark of Novo Nordisk Health Care AG . Novo Nordisk is a registered trademark of Novo Nordisk A / S . © 2016 Novo Nordisk All rights reserved . USA16HDM01857 September 2016