Garadacimab-ANDEMBRY instruction manual in Chinese

1. Name: garadacimab, garadacimab, ANDEMBRY

2. Indications:

Garadacimab (garadacimab)-ANDEMBRY is used to prevent the onset of hereditary angioedema (HAE) in adults and children 12 years of age and older.

3. Usage and dosage:

1. Recommended dose: The recommended dose of gadaximab is an initial loading dose of 400 mg subcutaneously on the first day of treatment (two injections of 200 mg), followed by a monthly maintenance dose of 200 mg subcutaneously.

2. Missed dose: If you miss a dose of gadaximab, please take it as soon as possible.

3. Instructions for the preparation and use of Ampere's prefilled auto-injectors and prefilled syringes with needle safety devices

Gadaximab is for subcutaneous use only, for self-administration or caregiver-administration. Before initiating treatment, educate patients/caregivers on the proper preparation and subcutaneous (SC) administration techniques of gadaximab.

Before administration, remove gadaximab from the refrigerator and leave it at room temperature for 30 minutes before use. Inject gadaximab subcutaneously into the thigh or abdomen, making sure it is 1 inch (2 cm) from the belly button. The upper arm may also be used if the caregiver is administering the subcutaneous injection. Discard used gadaximab in a sharps disposal container (closed puncture-resistant container).

4. Adverse reactions:

In clinical studies of gadaximab, common adverse reactions (incidence>7%) included nasopharyngitis and abdominal pain.

5. Supply and storage:

Gadaximab injection is a ready-to-use, slightly milky to clear, tan to yellow solution available in a single-dose prefilled autoinjector or a prefilled syringe with needle safety device (200 mg/1.2 mL [167 mg/mL]). Do not freeze. Don't shake. Store prefilled autoinjectors and prefilled syringes with needle safety devices in their original cartons to protect them from light. Store prefilled autoinjectors and prefilled syringes with needle safety devices refrigerated at 36°F to 46°F (2°C-8°C).

6. Taboo:

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7. Mechanism of action:

Gadaximabis an inhibitor of activatedFXII, binding to the catalytic domain (FXIIa and βFXIIa) of activated factor XII and inhibiting its catalytic activity. FXII is the first factor activated in the contact activation pathway and initiates the production of inflammatory bradykinin by the kallikrein-kinin system. Inhibition of FXIIa reduces the activation of kallikrein by prekallikrein and the production of bradykinin, which is associated with inflammation and swelling in HAE attacks, thereby reducing the cascade of events leading to HAE attacks.

8. Listing situation:

1. Original drug:

United States: 2025-06, approved for marketing (trade name: Andembry)

EU: 2025-02, approved for marketing (trade name: Andembry)

China: Not approved for listing yet

2. Generic drugs: None.

Reference materials:https://www.andembryhcp.com/