Fitusiran

QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

QFITLIA is a double-stranded siRNA that causes degradation of AT messenger RNA (mRNA) through RNA interference, reducing plasma AT levels.

For subcutaneous use only. Starting dose: 50 mg once every 2 months. Monitor AT activity using an FDA-cleared test. Maintain AT activity between 15–35% by adjusting the dose and/or frequency of administration. See Full Prescribing Information for important preparation and administration instructions.

None. None

Boxed warning: Thrombotic Events Serious thrombotic events have occurred in QFITLIA-treated patients with risk factors including persistent antithrombin (AT) activity less than 15%, QFITLIA 80 mg once monthly dosing, an indwelling venous catheter, and the post-operative setting when bleed management guidelines were not followed. Interrupt QFITLIA in patients with a thrombotic event and manage as clinically indicated. Hepatotoxicity: Obtain liver tests at baseline and then monthly for at least 6 months after initiating QFITLIA and after dose increases, and periodically thereafter. Liver test elevations may require QFITLIA interruption or discontinuation.

The following clinically significant adverse reactions are described elsewhere in the labeling: Thrombotic Events Acute and Recurrent Gallbladder Disease Hepatotoxicity Common adverse reactions (incidence >10%) are viral infection, nasopharyngitis, and bacterial infection.

Hypercoagulability with Concomitant Use of CFC or BPA QFITLIA prophylaxis leads to increased thrombin generation with additive increase in peak thrombin when used concomitantly with CFC or BPA.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. QFITLIA may be stored at room temperature between 15°C to 30°C (59°F to 86°F) for a single period of up to 3 months within the expiration date printed on the label. Discard no later than 3 months after removal from the refrigerator or at the expiration date, whichever comes first. After storage at room temperature, do not return the product to the refrigerator. 20 mg Vial Store QFITLIA either in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature between 15°C to 30°C (59°F to 86°F), in the original carton to protect from light.