Qfitlia (Fitusiran) instruction manual Chinese introduction

1. Name:Qfitlia, Fitusiran

2. Indications:

Qfitlia (Fitusiran) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding in adult and pediatric patients 12 years of age and older with hemophilia A or B, with or without factor VIII or IX inhibitors.

3. Usage and dosage:

1. Recommended dosage

Qfitlia is for subcutaneous use only. It is recommended that Qfitlia be used under the supervision of a healthcare professional experienced in treating hemophilia or bleeding disorders. Antithrombin-lowering (AT) activity was monitored using a U.S. Food and Drug Administration-approved test. The starting dose of Qfitlia is 50 mg, administered subcutaneously every two months. If necessary, adjust dose and/or dosing interval to maintain activity between 15-35%.

Measurements are taken in the activity before launching Qfitlia. If AT activity <60%, do not start dosing. After starting Qfitlia, patients can continue their previous clotting factor concentrate (CFC) or bypass agent (BPA) prophylaxis for the first 7 days of treatment. Stop CFC or BPA prophylaxis within 7 days after your first dose of Qfitlia.

2. Dosage modification

Activity measurements were performed using an FDA-approved test at weeks 4 (month 1), 12 (month 3), 20 (month 5), and 24 (month 6) after starting dosing and after any dose adjustment. If any AT activity <15%, dose reduction is required. The lower dose should be started 3 months after the previous dose. After dose reduction, AT measurements should be restarted. If AT activity is >35% after 6 months, or if the patient does not achieve satisfactory bleeding control, a dose increase should be considered. After dose increase, AT measurements should be restarted.

3. Preparation and administration instructions

QfitliaSuitable for use under the guidance of a healthcare provider. Provide patients and /or caregivers with appropriate training in preparing and administering Qfitlia(IFU) prior to use according to the instructions for use. Patients can inject Qfitlia themselves, or the patient's caregiver can give the patient Qfitlia. For pediatric patients 12 to 17 years of age, it is recommended that Qfitlia be administered by an adult or under adult supervision.

Qfitlia is administered by subcutaneous injection into the thigh or abdominal area (except 2 inches (5 cm) around the belly button). Caregivers can also inject Qfitlia into the outer area of u200bu200bthe patient's upper arm. Qfitlia should not be injected into delicate, damaged, bruised or scarred skin. Do not inject into a vein.

4. Adverse reactions:

In clinical studies of Qfitlia, common adverse reactions include viral infections, nasopharyngitis and bacterial infections.

5. Supply and storage:

Qfitlia is a colorless to pale yellow, clear solution available in single-dose prefilled pens or single-dose vials. Each prefilled pen is designed to hold 0.5 ml of 50 mg Qfitlia. Each vial is designed to deliver 0.2 ml of 20 mg of Qfitlia.

For prefilled pens, Qfitlia is stored refrigerated in the original carton at 2°C to 8°C (36°F to 46°F) to avoid light. Within the expiry date printed on the label, Qfitlia can be stored at room temperature between 15°C and 30°C (59°F and 86°F) for up to 3 months. Throw away from the refrigerator no later than 3 months or the expiration date, whichever comes first. After storing at room temperature, do not return product to the refrigerator.

For 20 mg vials of Qfitlia, store in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature at 15°C to 30°C (59°F to 86°F) in the original carton to protect from light. After storing at room temperature, do not return product to the refrigerator. Do not shake Qfitlia at any time. Do not heat Qfitlia. Do not freeze. Do not place in direct sunlight.

6. Mechanism of action:

Fitusiran, the main ingredient in Qfitlia, is a double-stranded siRNA that causes AT messenger RNA (mRNA) degradation through RNA interference and reduces plasma AT levels.

Reference materials:https://www.drugs.com/pro/qfitlia.html