Description

Indication & Scope

QFITLIA® (Fitusiran Sodium) is indicated for the routine prophylaxis of bleeding episodes in patients aged 12 years and older with severe hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors.

Mechanism: Fitusiran Sodium is a GalNAc-conjugated small interfering RNA (siRNA) that specifically targets antithrombin (AT) messenger RNA in hepatocytes. By reducing antithrombin production, it enhances thrombin generation and restores hemostatic balance, thereby reducing spontaneous and recurrent bleeding episodes.
Drug Class: Antithrombin-directed small interfering RNA (siRNA).
Clinical Use: Long-term prophylactic treatment for adolescents and adults with hemophilia A or B, regardless of inhibitor status.

Specification

Generic Name	Fitusiran Sodium Injection
Brand Name	QFITLIA®
Ingredient	Fitusiran Sodium
Dosage Form	Solution for Injection
Package	50 mg/0.5 mL per vial
Conditions Treated	Hemophilia A and Hemophilia B
Taboos	Hypersensitivity to fitusiran sodium or any excipient of the product. Do not initiate treatment in patients with baseline antithrombin activity below 60%.
Place of origin	United States
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store refrigerated at 2–8°C. Do not freeze. Keep in the original carton to protect from light.
Manufacturer	Genzyme Corporation
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	JXHS2400053
Date of Revision	2025
Shelf Life	24 months

How to use ?

Recommended Dose: The recommended starting dose is 50 mg administered by subcutaneous injection once every two months. Dose adjustments may be made based on antithrombin (AT) activity to maintain target AT levels of 15–35%. Depending on clinical response, the regimen may be adjusted to 20 mg every two months or 50 mg once monthly.

Time: Administer 50 mg by subcutaneous injection every 2 months. Dose regimen may be adjusted based on individual response and AT activity levels.

Instructions for use: Administer by subcutaneous injection into the abdomen, thigh, or upper arm using a pre-filled injection device. Rotate injection sites and do not inject into the same site repeatedly. Patients may self-administer after receiving appropriate training. Do not administer intravenously or intramuscularly.

Interaction: Fitusiran is not metabolized by CYP450 enzymes and has a low potential for CYP-mediated drug interactions. Concomitant use with coagulation factor replacement therapy requires careful monitoring due to potential thrombotic risk.

Side effects: Common adverse reactions include injection-site reactions, upper respiratory tract infections, fatigue, and increased liver enzymes. Important safety risks include thrombotic events and gallbladder-related disorders, such as cholecystitis and pancreatitis.

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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

How does Fitusiran work?

Fitusiran reduces hepatic production of antithrombin through RNA interference, increasing thrombin generation and restoring hemostatic balance.

How should QFITLIA® be administered?

QFITLIA® is administered by subcutaneous injection once every two months, with dosing adjusted according to antithrombin activity.

What are the common side effects?

Common adverse reactions include injection-site reactions, upper respiratory tract infection, fatigue, and elevated liver enzymes. Serious risks include thrombosis and gallbladder disease.

Can patients administer QFITLIA® themselves?

Yes. After receiving appropriate training from a healthcare professional, patients or caregivers may administer the injections at home.