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Important Safety Information | | | Prescribing Information
Indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia. See full indication below.
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The Facts About Factor VII Deficiency
Congenital factor VII deficiency (CFVIId) is a rare but serious condition where life-threatening bleeds may present early in life.
CNS and GI bleeds occur most frequently during the first 6 months of life, whereas 70% of CFVIId patients presenting with joint bleeds were less than five years of age.1
This makes early treatment crucial.
NovoSeven® RT is the only factor product approved for CFVIId.2 It's room-temperature stable which helps provide patients with rapid access to treatment.
Explore CFVIId data
CNS and GI bleeds occur most frequently during the first 6 months of life, whereas 70% of CFVIId patients presenting with joint bleeds were less than five years of age.1
This makes early treatment crucial.
NovoSeven® RT is the only factor product approved for CFVIId.2 It's room-temperature stable which helps provide patients with rapid access to treatment.
Explore CFVIId data
Keep scrolling to learn more about the safety and efficacy of NovoSeven® RT.
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
Please click here or scroll below for additional Important Safety Information.
A Safe and Effective Treatment is Available
NovoSeven® RT offers proven bleed control. In fact, it's 93% effective for nonsurgical and surgical bleeds in patients with congenital factor VII deficiency.2,3,a
It also offers a proven safety profile with a low rate of thrombotic events based on clinical trials and registries.4
aData was collected from published literature, compassionate use trials, and the HTRS for patients with congenital factor VII deficiency (N=70). NovoSeven® RT was used as treatment in 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 to 98 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.
Get the facts
A Safe and Effective Treatment is Available
NovoSeven® RT offers proven bleed control. In fact, it's 93% effective for nonsurgical and surgical bleeds in patients with congenital factor VII deficiency.2,3,a It also offers a proven safety profile with a low rate of thrombotic events based on clinical trials and registries.4
aData was collected from published literature, compassionate use trials, and the HTRS for patients with congenital factor VII deficiency (N=70). NovoSeven® RT was used as treatment in 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 to 98 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.
Get the facts
Treating Bleeds Wherever They Happen
NovoSeven® RT with MixPro® offers prefilled syringes designed to streamline the reconstitution process. This allows patients to keep it on hand and treat bleeds in 2-5 minutes.2
More about reconstitution
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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 (cont’d)
Warnings and Precautions
• | 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, including Boxed Warning.
References:
1. | Mariani G, Herrmann FH, Dolce A, et al. Clinical phenotypes and factor VII genotype in congenital factor VII deficiency. Thromb Haemost. 2005;93:481-487.
2. | NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
3. | Mariani G, Napolitano M, Dolce A, et al. Replacement therapy for bleeding episodes in factor VII deficiency. A prospective evaluation. Thromb Haemost. 2013;109:238-247.
4. | Rajpurkar M, Croteau SE, Boggio L, et al. Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC). Journal of Blood Medicine. 2019;10:335-340.
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