- 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
NovoSeven® RT achieved maximum activity within 5-10 minutes of infusion5,f,g
aResults shown are from the 70 mcg/kg group.
bData 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
cData 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
dIn patients with hemophilia A or B with inhibitors.2
eCalculation 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
gFVIIa activity IU/mL.
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
iThe minimum effective dose has not been determined.
BEFORE HEMOSTASIS IS ACHIEVED
adjustable based on severity of bleeding until hemostasis is achieved
AFTER HEMOSTASIS IS ACHIEVED
after hemostasis is achieved for severe bleeds
hIn patients with hemophilia A or B with inhibitors.2
iThe minimum effective dose has not been determined.
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.
NovoSeven® RT was used safely in 61 patients treating with emicizumab in 3 separate pivotal trials: HAVEN 1, 2, and 4.8,9,k
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.
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.
Every vial comes with a prefilled syringe, meaning no extra steps to fill a syringe with diluent.1,m
mCompared with reconstitution using histidine vials.
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.
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:
Adapted from Shapiro et al.11,r
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
rIn patients with hemophilia A or B with inhibitors. Actual length of postoperative period may vary.
WARNING: THROMBOSIS
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:
WARNING: THROMBOSIS
References: