Description
Indication & Scope
QFITLIA® Fitusiran Sodium Injection provides routine bleeding prophylaxis to lower bleeding episode frequency in patients aged 12 years and older with hemophilia A or B, with or without clotting factor inhibitory antibodies.
- Mechanism: Small interfering RNA (siRNA) therapeutic targeting hepatic antithrombin messenger RNA. It silences hepatic antithrombin protein synthesis, reduces endogenous circulating antithrombin levels, restores balanced blood coagulation activity and prevents spontaneous bleeding without repeated factor replacement.
- Drug class: Hepatic antithrombin-directed siRNA therapeutic / Hemophilia prophylactic nucleic acid injectable drug.
- Clinical use: Long-term once-monthly subcutaneous prophylaxis for adolescents and adults with hemophilia A/B, effective for inhibitor-positive patients unsuitable for standard factor replacement regimens.
| Generic Name | Fitusiran Sodium Injection |
| Brand Name | QFITLIA |
| Ingredient | Fitusiran Sodium |
| Dosage Form | Injection |
| Package | 0.2ml: 20mg*1 vial/box;
0.5ml: 50mg*1 syringe/box |
| Conditions Treated | Hemophilia A and Hemophilia B (with or without factor inhibitors) |
| Taboos | Severe hypersensitivity to fitusiran sodium or nucleic acid formulation excipients; patients with baseline severe liver cirrhosis or decompensated hepatic failure; active gallbladder disease patients |
| Place of origin | Schuetzenstrasse 87, 99-101, Ravensburg, Baden-Wurttemberg 88212 GERMANY |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed prefilled syringes refrigerated at 2°C–8°C, strictly avoid freezing; shield from UV light exposure |
| Manufacturer | Vetter Pharma-Fertigung GmbH & Co. KG |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20250145; HJ20250146 |
| Approval Date | Dec 9, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard fixed dose 80 mg subcutaneous injection administered once every four weeks (monthly).
Time: Monthly fixed-day subcutaneous injection, independent of meal timing cycles.
Instructions for use: Administer single subcutaneous injection into abdomen or thigh; perform baseline liver function testing before initiation, monitor liver enzymes monthly for minimum six months after first dose; monitor gallbladder ultrasound periodically during long-term treatment.
Interaction: Concurrent bypassing clotting agents raise arterial/venous thrombotic event risk; monitor coagulation screening tests during breakthrough bleeding management.
Side effects:
1. Common mild adverse reactions: injection site discomfort, headache, mild transaminase elevation, fatigue.
2. Boxed severe risks: thromboembolic events, gallstone formation and gallbladder disease, drug-induced liver injury.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What liver protein synthesis does Fitusiran Sodium Injection silence via siRNA gene suppression?
It suppresses hepatic production of antithrombin protein through mRNA interference.
What is the standard dosing interval for Fitusiran Sodium Injection hemophilia prophylaxis injection?
Fixed 80 mg subcutaneous injection once every four weeks (monthly).
What two severe class-wide safety risks carry mandatory clinical monitoring warnings when using Fitusiran Sodium Injection?
Increased blood clot thrombosis risk and drug-induced liver toxicity.
What baseline organ function test is required before starting Fitusiran Sodium Injection therapy?
Baseline liver function blood tests measuring ALT and AST enzymes.
QFITLIA® | Fitusiran Sodium Injection | Hemophilia | DengYueRX
INN: Fitusiran Sodium Injection
Indications: Hemophilia
Dosage Form: Injection
Strength: 0.2ml: 20mg/vial; 0.5ml: 50mg/syringe
