Concizumab-Mtci Application Scope

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged 12 years and older with hemophilia A (with factor VIII inhibitors) or hemophilia B (with factor IX inhibitors) .

Concizumab-Mtci Characteristics

Ingredients: Concizumab-mtci is a recombinant, humanized monoclonal antibody that targets tissue factor pathway inhibitor (TFPI).
Properties: Acts as a TFPI antagonist, enhancing thrombin generation and improving clot formation in patients with hemophilia A or B with inhibitors .
Specification: Administered as a subcutaneous injection via prefilled pens in specified dosages.
Packaging Specification: Prefilled, premixed pens designed for subcutaneous injection using a 32-gauge, 4 mm needle (needle provided separately) .
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Once in use, can be stored at room temperature (below 30°C or 86°F) for up to 28 days. Protect from light and do not freeze .
Expiry Date: 24 months from the date of manufacture when stored at 2°C to 8°C, including an in-use period of 4 weeks below 30°C .
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) under Biologics License Application (BLA) 761315.
Approval Number: BLA 761315 .
Date of Revision: December 2024 .
Manufacturer: Novo Nordisk Inc.

Guidelines for the Use of Concizumab-Mtci

Dosage and Administration:
- Loading Dose: 1 mg/kg administered subcutaneously on Day 1.
- Maintenance Dose: 0.2 mg/kg administered subcutaneously once daily starting on Day 2.
- Dose Adjustment: After 4 weeks, measure plasma concizumab levels to individualize maintenance dosing:
  - <200 ng/mL: Increase to 0.25 mg/kg once daily.
  - 200–4000 ng/mL: Continue 0.2 mg/kg once daily.
  - 4000 ng/mL: Decrease to 0.15 mg/kg once daily .
Adverse Reactions:
- Common (≥5%): Injection site reactions (18%), urticaria (6%) .
- Less Common (1–10%): Increased fibrin D-dimer levels (9.1%), increased prothrombin fragment 1+2 levels (5.6%) .
- Rare (<1%): Hypersensitivity reactions, including anaphylaxis .
Contraindications:
- Known serious hypersensitivity to concizumab-mtci or any of its components .
Precautions:
- Thromboembolic Events: Reported in 1.3% of patients; caution advised in patients with multiple risk factors for thrombosis .
- Hypersensitivity Reactions: Monitor for signs of allergic reactions; discontinue use if severe reactions occur .
- Laboratory Monitoring: Increased levels of fibrin D-dimer and prothrombin fragment 1+2 may not reliably predict thrombosis; interpret with caution .
- Pregnancy: Potential risk to the fetus; use only if the potential benefit justifies the potential risk .

Concizumab-Mtci Interactions

Drug Interactions:
- No significant drug interactions have been reported.
- Bypassing Agents: When treating breakthrough bleeding episodes, use the lowest effective dose of bypassing agents. For activated prothrombin complex concentrate (aPCC), do not exceed 100 units/kg within 24 hours .

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.