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| 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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| Success Speaks for Itself | Hospital Series |
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Factor VII Deficiency:
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Here's What to Know.
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| 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
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| 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. |
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| 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. |
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Keep scrolling to learn more about the safety and efficacy of NovoSeven® RT.
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| Selected Important Safety Information |
| WARNING: THROMBOSIS |
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Serious arterial and venous thrombotic events following administration
of NovoSeven® RT have been reported
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Discuss the risks and explain the signs and symptoms of thrombotic and
thromboembolic events to patients who will receive
NovoSeven® RT
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Monitor patients for signs or symptoms of activation of the coagulation
system and for thrombosis
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| Warnings and Precautions |
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Serious arterial and venous thrombotic events have been reported in clinical trials
and postmarketing surveillance
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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
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| Please click here or scroll below for additional Important Safety Information. |
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| A Safe and Effective Treatment is Available |
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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
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| 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.
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| 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 |
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| 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. |
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Treating Bleeds Wherever They Happen
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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
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| Have you created an account on novoMEDLINK™? |
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| Keep up with important information about treatments for rare bleeding disorders. |
| Receive the latest news about rare bleeding disorders from Novo Nordisk. |
| Download, order, and share educational materials for you and your patients. |
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| Indications and Usage |
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NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor
indicated for:
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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
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Treatment of bleeding episodes and perioperative management in adults with acquired
hemophilia
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| Important Safety Information (cont’d) |
| Warnings and Precautions |
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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
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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
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Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct
correlation to achieving hemostasis
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| Adverse Reactions |
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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
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| Drug Interactions |
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Thrombosis may occur if NovoSeven® RT is administered
concomitantly with Coagulation Factor XIII
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Please click here for
Prescribing Information, including Boxed Warning.
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| 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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