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Qfitlia™ (fitusiran) is a first-in-class antithrombin-lowering agent1,2


Qfitlia helps restore hemostasis by lowering antithrombin for people with hemophilia A or B, with or without inhibitors1

Convenient injection experience with a device designed for patients by patients1

Discover Dosing and Administration

Self injection pen

Qfitlia offers the fewest doses for any prophylactic treatment1,3-15

the number 6 in a yellow cercal background

As few as 6 injections a year1

  • The starting dose of Qfitlia is 50 mg every two months
  • Antithrombin activity levels must be measured, and the dose should be adjusted, if needed, to ensure that antithrombin levels between 15% and 35% are achieved
  • In the clinical study of 227 patients, ~67% of people with hemophilia took Qfitlia every other month, and ~19% took it monthly
man lifting weights

Discover the novel MOA1,2

Qfitlia is a first-in-class antithrombin-lowering agent that helps restore hemostasis.1,2

man walking

Proven bleed protection1

Get the details of the proven efficacy of Qfitlia and how it compares to other therapies.1

INDICATION

Qfitlia™ (fitusiran) is an antithrombin (AT)-directed small interfering ribonucleic acid (siRNA) 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.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOTIC EVENTS AND ACUTE AND RECURRENT GALLBLADDER DISEASE

THROMBOTIC EVENTS
Serious thrombotic events have occurred in Qfitlia-treated patients with risk factors for thromboembolism including persistent antithrombin (AT) activity less than 15%, use of Qfitlia 80 mg once monthly, presence of indwelling venous catheters, and in the post-operative setting when Bleed Management Guidelines were not followed. 

Monitor AT activity using an FDA-cleared test and target AT activity 15-35% to reduce the risk of thrombosis. Monitor patients for signs and symptoms of thrombotic events. Interrupt Qfitlia in patients with a thrombotic event and manage as clinically indicated.

ACUTE AND RECURRENT GALLBLADDER DISEASE
Acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis have occurred in Qfitlia-treated patients, some of whom required cholecystectomy or had complications (e.g., pancreatitis) related to gallbladder disease. Monitor patients for signs and symptoms of acute and recurrent gallbladder disease. 

Consider interruption or discontinuation of Qfitlia if gallbladder disease occurs. Consider alternative treatment for hemophilia in patients with a history of symptomatic gallbladder disease.

WARNINGS AND PRECAUTIONS
Thrombotic Events:  

  • Serious thrombotic events have been reported in Qfitlia-treated patients. Thrombotic events were reported in 2.6% of patients receiving the 80 mg once monthly dose, including a fatal event of cerebral venous sinus thrombosis. The 80 mg once monthly dose is not approved or recommended for use. Thrombotic events were reported in 1.4% of patients receiving Qfitlia prophylaxis using the AT-based dose regimen (AT-DR) that targeted AT activity 15-35%
  • The risk of thrombosis is greater in patients with certain risk factors (see Boxed WARNING). Treatment of breakthrough bleeding episodes with clotting factor concentrate (CFC) or bypassing agent (BPA) at a dose greater or more frequent than recommended may also increase thrombotic risk

Acute and Recurrent Gallbladder Disease: 

  • Treatment with Qfitlia is associated with an increased occurrence of acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis (see Boxed WARNING). In the 270 patients in the clinical studies who received Qfitlia at a fixed dose of 80 mg once monthly, 17% experienced gallbladder events and 4% underwent cholecystectomy. In 286 patients who received the AT-DR, 3.8% experienced gallbladder events and 0.3% underwent cholecystectomy

Hepatotoxicity: 

  • In the two randomized studies testing Qfitlia 80 mg once monthly, alanine transaminase (ALT) and aspartate transaminase (AST) elevations above 3 times the upper limit of normal (ULN) occurred in 32% of patients with hemophilia with inhibitors and 18% of patients with hemophilia without inhibitors. There was one case of moderate hepatic injury attributable to Qfitlia use. On the AT-DR, 3.4% of patients treated with Qfitlia had at least one ALT value >3x ULN
  • Avoid use of Qfitlia in patients with hepatic impairment (Child-Pugh Class A, B, and C)
  • Obtain baseline liver tests, including AST, ALT, and total bilirubin, prior to initiating Qfitlia, monthly for at least the first 6 months of Qfitlia use, monthly for at least 6 months after a dose increase, and periodically thereafter as clinically indicated  
  • If new or worsening liver test abnormalities occur, initiate medical management as appropriate and monitor until they return to baseline. If ALT or AST elevations >5x ULN occur, interrupt Qfitlia treatment. If Qfitlia is restarted and ALT or AST elevations >5x ULN reoccur or the patient experiences jaundice due to hepatotoxicity with other causes of liver test elevation ruled out, permanently discontinue Qfitlia

DRUG INTERACTIONS
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.

ADVERSE REACTIONS
Common adverse reactions (incidence ≥10%) are viral infection, nasopharyngitis, and bacterial infection.

INDICATION

IMPORTANT SAFETY INFORMATION

MOA=mechanism of action.

References: 1. Qfitlia Prescribing Information. Genzyme Corporation. Cambridge, MA. 2. Machin N, et al. J Blood Med. 2018;9:135-140. 3. Advate Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. 4. Adynovate Prescribing Information. Takeda Pharmaceutical U.S.A., Inc. Lexington, MA. 5. Afstyla Prescribing Information. CSL Behring LLC. Kankakee, IL. 6. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA. 7. Esperoct Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 8. Helixate Prescribing Information. CSL Behring LLC. Kankakee, IL. 9. Hemlibra Prescribing Information. Genentech, Inc. San Francisco, CA. 10. Jivi Prescribing Information. Bayer HealthCare LLC. Whippany, NJ. 11. Kogenate Prescribing Information. Bayer HealthCare LLC. Whippany, NJ. 12. Kovaltry Prescribing Information. Bayer HealthCare LLC. Whippany, NJ. 13. Novoeight Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. 14. Nuwiq Prescribing Information. Octapharma USA, Inc. Paramus, NJ. 15. Xyntha Prescribing Information. Wyeth Pharmaceuticals LLC. Philadelphia, PA.

© 2025 Sanofi. All rights reserved. Qfitlia and Sanofi are trademarks of Sanofi or an affiliate. Qfitlia is sold under license from Alnylam Pharmaceuticals, Inc. MAT-US-2413046-v1.0-03/2025 Last updated: March 2025