Emicizumab is a revolutionary humanized bispecific monoclonal antibody that mimics the function of coagulation factor VIII by bridging activated coagulation factors IX and X.

Indications of Emicizumab

Main Indications

Emicizumab is approved for routine prophylactic treatment in adult and pediatric patients with hemophilia A who have developed coagulation factor VIII inhibitors, aiming to reduce or prevent the occurrence of bleeding events.

Target Population: Patients with congenital factor VIII (FVIII) deficiency (hemophilia A) who have developed FVIII inhibitors, covering infants aged 1 month and above to adults.

Treatment Goal: Achieve long-term steady-state plasma drug concentrations through weekly subcutaneous injections, thereby reducing the risk of spontaneous bleeding and joint bleeding.

Special Notes: This drug is not suitable for patients with non-inhibitor hemophilia A. Additionally, bypass agent prophylaxis regimens must be discontinued 24 hours before initiating treatment with this drug.

Specifications and Properties of Emicizumab

Dosage Form Specifications

30mg/mL (1mL/vial): Contains 26.1mg of L-arginine and 3.1mg of L-histidine.

60mg/0.4mL (150mg/mL): Contains 10.5mg of L-arginine.

105mg/0.7mL (150mg/mL): Contains 18.3mg of L-arginine.

150mg/mL (1mL/vial): Contains 26.1mg of L-arginine.

Physicochemical Properties

Appearance: Clear solution ranging from colorless to pale yellow, with a pH of 6.0 (in an L-aspartic acid buffer system).

Excipients: Contains Poloxamer 188 (as a stabilizer) and no preservatives.

Contraindications for Use: If the solution is turbid, discolored, or contains particles, it must be discarded.

Storage Methods of Emicizumab

Routine Storage

Temperature: 2°C–8°C (refrigerator cold storage compartment).

Light Protection: Store in the original packaging box.

Prohibitions: Freezing or vigorous shaking is strictly prohibited.

Temporary Retrieval and Use

Unopened vials can be stored at a temperature of ≤30°C for a cumulative period of no more than 7 days, but the time away from refrigeration must be recorded.

Once the drug solution is drawn into a syringe, it must be used immediately.

Waste Disposal

Any remaining drug solution in single-dose vials must be discarded.

Used injection devices shall be disposed of in accordance with medical sharp instrument regulations.