Breakthrough bleeds are treated differently while on Qfitlia than other treatments1
Qfitlia prophylaxis leads to increased thrombin generation with an additive increase in peak thrombin when used concomitantly with factor replacement or BPA.1
Therefore, the initial weight-based dose of factor replacement or BPA should be reduced and the dosing interval doubled compared to the standard dose.1
For breakthrough bleeds occurring more than 7 days after the first dose of Qfitlia1,2
For patients using on-demand treatment with factor replacement or BPA after Qfitlia initiation, the prior dosing regimen of factor replacement or BPA therapy may be used to treat breakthrough bleeding episodes only for the first 7 days.1,2
If adequate hemostatic control is not achieved, higher doses may be used per clinical judgment.1
* For situations requiring higher doses, more frequent administration, or multiple repeat doses, use clinical judgment. Adjunctive management of bleeding episodes and cases of thrombosis should be carried out per SOC.1
Qfitlia was used in over 100 surgeries without treatment discontinuation1
BMG should be utilized during the perioperative period for hemostatic management.
Breakdown of major surgeries3†
Adherence to the BMG on the recommended dose of factor replacement or BPA may help minimize the risk of TEs while on Qfitlia.1
The ATLAS studies were not designed to evaluate surgical outcomes; no conclusions on the benefit of Qfitlia use during surgery can be drawn from these data.
† Major surgeries were any invasive procedures requiring: opening into a major body cavity (eg, abdomen, thorax, skull); operation on a joint; removal of an organ; dental extraction of any molar teeth or ≥3 non-molar teeth, or any tooth implantation; operative alteration of normal anatomy; or crossing of a mesenchymal barrier (eg, pleura, peritoneum, dura).2
Bleed management experience in people who were treated with Qfitlia4‡§
These data are exploratory in nature and not statistically proven. Results are descriptive, and definitive conclusions cannot be made.
‡ Based on an analysis including males aged ≥12 years with severe hemophilia A or B, with or without inhibitors, who received ≥1 dose of Qfitlia in ATLAS-PPX and then continued AT-DR in the ATLAS-OLE study. Factor replacement /BPA was used for the management of breakthrough bleeds during both periods and for SOC prophylaxis during the factor replacement /BPA period.4
§ People with hemophilia with and without inhibitors required a median of 1 infusion of factor replacement /BPA while on Qfitlia prophylaxis to control a bleed.4
aPCC=activated prothrombin complex concentrate; AT-DR=antithrombin-based dosing regimen; BPA=bypassing agent; EHL=extended half-life; FIX=Factor IX; FVIII=Factor VIII; IU=international unit; rFVIIa=recombinant Factor VIIa; SHL=standard half-life; SOC=standard of care; TE=thrombotic event.
INDICATION
References: 1. Qfitlia Prescribing Information. Genzyme Corporation. Cambridge, MA. 2. Data on file CSR. SAR439774-LTE15174 - fitusiran. November 2023. 3. Srivastava A, et al. Surgical experience in people with hemophilia A or B with and without inhibitors receiving fitusiran. Presented at: ISTH 2024; June 23, 2024; Bangkok, Thailand. 4. Pipe SW, et al. 128 Reduced doses of factor concentrates and bypassing agents to treat breakthrough bleeds in patients with hemophilia A and B on fitusiran antithrombin-based dosing regimen: ATLAS-OLE. Abstract presented at: 66th ASH Annual Meeting; December 7, 2024; San Diego, CA. Session 322. 5. Data on file.
