Fitusiran: uses, dosing, side effects & brands
Fitusiran is an antithrombin-directed rna interaction sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antithrombin-Directed Rna Interaction
- Available as
- Injectable
- Sold as
- Qfitlia
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How fitusiran is dosed
From the FDA label for Qfitlia (application NDA219019). Other fitusiran products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous use only. Starting dose: 50 mg once every 2 months ( 2.1 ). Monitor AT activity using an FDA-cleared test. Maintain AT activity between 15–35% by adjusting the dose and/or frequency of administration ( 2.2 ). See Full Prescribing Information for important preparation and administration instructions ( 2.4 ). 2.1 Recommended Dosage For subcutaneous use only. Use of QFITLIA is recommended under the supervision of a healthcare professional experienced in the treatment of hemophilia or bleeding disorders. Measure AT activity prior to initiation of QFITLIA. Do not initiate QFITLIA dosing if AT activity is <60%. Monitor AT activity using an FDA-cleared test. Information on FDA-cleared tests for AT activity is available at http://www.fda.gov/CompanionDiagnostics. After QFITLIA is initiated, patients may continue their prior clotting factor concentrates (CFC) or bypassing agent (BPA) prophylaxis for the first 7 days of treatment. Discontinue CFC or BPA prophylaxis no later than 7 days after the initial dose of QFITLIA. The starting dose of QFITLIA is 50 mg once subcutaneously every two months. Adjust the dose and/or dosing interval, if needed, to maintain AT activity between 15–35% [see Boxed Warning , Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . 2.2 Dosage Modification Measure AT activity using an FDA-cleared test at Weeks 4 (Month 1), 12…
Fitusiran side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1) ] Acute and Recurrent Gallbladder Disease [see Boxed Warning and Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Common adverse reactions (incidence >10%) are viral infection, nasopharyngitis, and bacterial infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to QFITLIA as fixed doses and AT-DR (N=335). The safety of the QFITLIA AT-DR was assessed in 286 adult and pediatric male patients with hemophilia A or B with or without inhibitors [see Clinical Studies (14) ] . Among patients who received the AT-DR, 93% were exposed for 6 months or longer and 83% were exposed for 12 months or longer. The median duration of exposure across the studies was 674 days (with a maximum of 896 days). Serious adverse…
Who shouldn’t take fitusiran
None. None ( 4 )
Fitusiran drug interactions
7.1 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 [see Boxed Warning , Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] .
Every fitusiran product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Qfitlia.
Related calculators
Frequently asked questions
What is fitusiran?
QFITLIA injection contains fitusiran, an antithrombin-directed double-stranded small interfering ribonucleic acid (siRNA), which is covalently linked to a ligand containing a triantennary N-acetylgalactosamine (GalNAc) moiety.
What kind of drug is fitusiran?
The FDA classifies fitusiran as an antithrombin-directed rna interaction. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take fitusiran with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fitusiran against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does fitusiran come in?
Across the brands we track, fitusiran is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic fitusiran?
We do not currently list a generic-labelled fitusiran product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Fitusiran: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fitusiran
- MLA
- “Fitusiran: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fitusiran.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for fitusiran on DailyMed (NIH) ↗ — including its boxed warning in full.