Caplacizumab must be used in conjunction with plasma exchange and immunosuppressive therapy. Precise timing of medication administration and standardized injection techniques are crucial for ensuring efficacy and safety. During clinical application, dynamic assessment of bleeding risk and disease activity is required to avoid treatment interruption or dosage deviations.

Dosage and Administration of Caplacizumab (Cablivi)

1. Recommended Dosage and Administration Regimen

First day of treatment: Administer an intravenous bolus of 11 mg at least 15 minutes before plasma exchange; on the same day after the completion of plasma exchange, give a subcutaneous injection of 11 mg.

Subsequent treatment during daily plasma exchange: After daily plasma exchange, administer a subcutaneous injection of 11 mg.

Post-plasma exchange treatment: After the last daily plasma exchange, administer a subcutaneous injection of 11 mg once daily for 30 consecutive days. If there are signs of persistent underlying disease (e.g., suppressed ADAMTS13 activity level) after the initial treatment course, the treatment can be extended for a maximum of 28 days.

Management of recurrence: If a patient experiences more than 2 recurrences of acquired thrombotic thrombocytopenic purpura (aTTP) during treatment with caplacizumab, the drug should be discontinued.

Management of missed doses: If a dose is missed during the plasma exchange period, it should be supplemented as soon as possible; if a dose is missed after the plasma exchange period, administration can be given if it is within 12 hours of the scheduled dose. If more than 12 hours have passed, the missed dose should be skipped, and the next dose should be given according to the regular administration schedule.

2. Discontinuation for Surgery and Other Interventions

Caplacizumab should be discontinued 7 days before elective surgery, dental procedures, or other invasive interventions.

3. Reconstitution and Administration Instructions

The first dose must be administered via intravenous bolus by a healthcare professional. Subsequent doses are given as subcutaneous injections in the abdomen, avoiding the area around the navel, and consecutive injections should not be given in the same abdominal quadrant. Patients or caregivers may administer subcutaneous injections after receiving appropriate training on the preparation and administration of caplacizumab (including aseptic techniques).

Ensure that the caplacizumab vial and diluent syringe are at room temperature. Reconstitute caplacizumab using the accompanying syringe containing 1 mL of Water for Injection (USP) to obtain a single-dose solution with a concentration of 11 mg/mL.

Use aseptic techniques throughout the solution preparation process: Attach the vial adapter to the vial containing caplacizumab, remove the plastic cap of the syringe, and connect the syringe to the vial adapter by rotating it clockwise until it can no longer turn. Slowly push the syringe plunger until the syringe is empty, and do not remove the syringe from the vial adapter. Gently rotate the vial until the cake or powder is completely dissolved; do not shake the vial.

Visually inspect the reconstituted solution to ensure it is clear and colorless. Draw all of the clear and colorless reconstituted solution from the vial into the syringe, label the syringe as containing caplacizumab, and then inject the entire volume of the reconstituted solution.

For the initial intravenous injection: If an intravenous infusion set is used, the glass syringe should be connected to a standard Luer lock (not a needle-free connector) and flushed with 0.9% Sodium Chloride Injection (USP) or 5% Dextrose Injection (USP).

The reconstituted caplacizumab solution should be used immediately. If not used immediately, it can be stored in a refrigerator at 2°C–8°C (36°F–46°F) and must be used within 4 hours after reconstitution.