^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.

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.

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.

^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.