Prescription medicine
Fitusiran Brand names: Qfitlia
Fitusiran (Qfitlia) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the fitusiran FDA label on DailyMed (effective September 16, 2025, Genzyme Corporation); the NDA 219019 record on Drugs@FDA; every fitusiran label on DailyMed.
Highlights of the record
FDA label of September 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
THROMBOTIC EVENTS AND ACUTE AND RECURRENT GALLBLADDER DISEASE WARNING: THROMBOTIC.
EVENTS and ACUTE AND RECURRENT GALLBLADDER DISEASE See full prescribing information for complete 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. ( 5.1 ) Acute and Recurrent Gallbladder Disease Gallbladder disease has occurred in QFITLIA-treated patients, some requiring cholecystectomy or developing complications (e.g., pancreatitis). Monitor for signs and symptoms of gallbladder disease. Consider interruption or discontinuation of QFITLIA if gallbladder disease occurs. Consider alternative treatment for hemophilia if history of symptomatic gallbladder disease. ( 5.2 ) 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. […]
Used for
From the label: indications and usageQFITLIA 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.
Forms and strengths
- 20 mg/.2ml
- 50 mg/.5ml
Injection (solution).
On the market
- Earliest approval on file
- March 28, 2025 Qfitlia, Genzyme Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 7, 2036 Qfitlia injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 44 through July 30, 2026
What is fitusiran used for?
From the label: indications and usageQFITLIA 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.
FDA pharmacologic class: Antithrombin-directed RNA Interaction and Small Interfering RNA.
Source: FDA drug label (Qfitlia), Genzyme Corporation, effective September 16, 2025 (SPL set 6dd2f8ac-6f90-4cbf-b197-97d74964135c), via openFDA; the full label on DailyMed
What does the patient leaflet for fitusiran say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about QFITLIA?QFITLIA helps your blood form clots. Do not stop using QFITLIA without talking to your healthcare provider. If you miss doses or stop using QFITLIA, you may no longer be protected against bleeding. Use of a clotting factor concentrate (CFC) or bypassing agent (BPA) to help protect against bleeding must be stopped within 7 days after your first dose of QFITLIA. Your healthcare provider may prescribe on demand CFC (factor VIII or factor IX products) or BPA if you bleed during treatment with QFITLIA. Carefully follow your healthcare provider's instructions regarding when to use on-demand treatment with CFC or BPA, including the prescribed dose and timing of the CFC or BPA. QFITLIA can cause serious side effects, including: Abnormal blood clotting (thrombotic events). Serious blood clots have happened in people treated with QFITLIA. QFITLIA can cause blood clots to form in blood vessels in your arms, legs, lungs, heart, brain, eyes, or head. Your risk of blood clots is greater if your antithrombin (AT) blood level is persistently less than 15% or if you have certain other conditions. Get medical help right away if you get any of these signs or symptoms of blood clots during or after treatment with QFITLIA: swelling, pain or redness in arms or legs coughing up blood shortness of breath severe chest pain or tightness of the chest fast heart rate feeling faint or passing out severe or persistent headache difficulty speaking or understanding language feel confused numbness or weakness in your face, arms or legs sudden loss or changes in your vision, eye pain or swelling Gallbladder disease. QFITLIA can cause gallstones (cholelithiasis) and inflammation of your gallbladder (cholecystitis), which might require surgery to remove your gallbladder. […]
From the patient leaflet: How should I store QFITLIA?50 mg Prefilled Pen Store QFITLIA prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. QFITLIA prefilled pen may be stored at room temperature between 59°F to 86°F (15°C to 30°C) for a single period of up to 3 months within the expiration date printed on the label. Throw away (dispose of) the QFITLIA prefilled pen after 3 months at room temperature or at the expiration date, whichever comes first. Do not return QFITLIA prefilled pen to the refrigerator after storing at room temperature. 20 mg Vial Store QFITLIA vial in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton to protect from light. Do not return QFITLIA vial to the refrigerator after storing at room temperature. Do not shake the QFITLIA vial or prefilled pen at any time. […]
Source: FDA drug label (Qfitlia), Genzyme Corporation, effective September 16, 2025 (SPL set 6dd2f8ac-6f90-4cbf-b197-97d74964135c), via openFDA; the full label on DailyMed
Is there a generic for fitusiran (Qfitlia)?
No generic fitusiran is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Qfitlia injection: the compound patent runs to March 22, 2033, and the last listed entry to December 7, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for fitusiran?
The FDA Adverse Event Reporting System holds 44 reports that list fitusiran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other small interfering rnas
- the pharmacologic class, with prices and generics
- Fitusiran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other