Fitusiran Application Scope

Fitusiran is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients aged 12 years and older with:

Fitusiran Characteristics

Ingredients: Fitusiran is a small interfering RNA (siRNA) therapeutic that targets antithrombin to enhance thrombin generation and improve hemostasis in hemophilia patients.
Properties: Antithrombin production inhibitor; RNA interference (RNAi) agent
Packaging Specification: 20 mg/0.2 mL vials and 50 mg/0.5 mL prefilled pens
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Expiry Date: Refer to the packaging for the specific expiration date.
Executive Standard: Not specified in the provided information.
Approval Number: FDA approved on March 28, 2025.
Date of Revision: March 29, 2025.
Manufacturer: Sanofi

Dosage and Administration:
- Initial dose: 50 mg subcutaneously every 2 months.
- Adjust dose and/or interval to maintain antithrombin activity between 15–35%.
- Administer subcutaneously into the thigh, abdomen, or upper arm (if given by a caregiver).
- Avoid injection into veins or damaged skin.
Adverse Reactions:
- Common (>10%): Viral infections, nasopharyngitis, bacterial infections.
- Less Common (1–10%): Hepatic injury, arthralgia, injection site reactions, headache, cough, gallbladder events, thrombotic events.
Contraindications: No specific contraindications listed.
Precautions:
- Thrombotic Events: Serious thrombotic events have occurred, especially with antithrombin activity <15%. Monitor antithrombin levels and adjust dosing accordingly.
- Gallbladder Disease: Monitor for signs of cholelithiasis and cholecystitis; consider discontinuation if gallbladder disease occurs.
- Hepatotoxicity: Monitor liver function tests at baseline and monthly for at least 6 months after initiating treatment or after dose increases.
- Pregnancy and Lactation: Data are unavailable; advise non-hormonal contraception during treatment.

Drug Interactions:
Avoid concomitant use with clotting factor concentrates (CFCs) or bypassing agents (BPAs) beyond 7 days after initiating Fitusiran, as this may increase the risk of thrombosis.
If breakthrough bleeding occurs, manage with reduced doses and frequency of CFCs/BPAs

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.