C1 Inhibitor Human｜Hereditary Angioedema｜HongKong DengYue Medicine

C1 Inhibitor HumanApplication Scope

C1 Inhibitor Human is indicated for:

• Treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients.

• Routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients (6 years and older) with HAE.

C1 Inhibitor Human Characteristics

Ingredients:

• Active Ingredient: C1 Inhibitor Human, a plasma-derived protein.

• Excipients vary by product formulation.

Properties:

• Appearance: Lyophilized powder for reconstitution.

• Source: Human plasma.

• Purity: >95% by SDS-PAGE.

Specification:

• Available in single-dose vials containing 500 IU of C1 Inhibitor Human.

Packaging Specification:

• Supplied in single-dose vials with accompanying diluent for reconstitution.​

Storage:

• Store at 2°C to 25°C (36°F to 77°F).

• Do not freeze.

• Protect from light.

Expiry Date:

• Refer to the expiration date printed on the vial label and carton.​

Executive Standard:

• Manufactured in accordance with current Good Manufacturing Practices (cGMP) and applicable regulatory standards.​

Approval Number:

• FDA Biologics License Application (BLA) Number: 125287.

Date of Revision:

• Refer to the latest revision date on the official prescribing information.​

Manufacturer:

• CSL Behring GmbH.

Guidelines for the Use of C1 Inhibitor Human

Dosage and Administration:

• For Acute HAE Attacks:

  • Administer 20 IU per kg body weight by intravenous injection.

• For Routine Prophylaxis:

  • Dosage varies based on specific product formulations and patient needs; refer to prescribing information for detailed guidance.​

Adverse Reactions:

• Common adverse reactions include:

  • Headache

  • Nausea

  • Rash

  • Vomiting

  • Fever

• Serious allergic reactions, including anaphylaxis, may occur.

Contraindications:

• Known life-threatening hypersensitivity reactions, including anaphylaxis, to C1 Inhibitor Human preparations. ​

Precautions:

• Monitor patients for signs of hypersensitivity reactions during and after administration.

• Use with caution in patients with a history of thromboembolic events. ​

C1 Inhibitor Human Interactions

Drug Interactions:

• No formal drug interaction studies have been conducted.

• Use caution when administering concurrently with medications that increase the risk of thrombosis.​

 

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.