- Indications and Usage Lanadelumab is indicated for the prevention of angioedema attacks in patients with hereditary angioedema (HAE) aged 2 years and older.
- Dosage and Administration Standard Dosage: The recommended dosage is 300 mg administered subcutaneously every 2 weeks. Dosage Adjustment: The dosage may be extended to every 4 weeks based on clinical judgment if the patient remains attack-free for at least 6 months. Administration: Must be administered by a qualified healthcare professional. It is for subcutaneous use only and must not be administered intravenously. The injection site should be rotated, and the medication should be inspected visually for particulate matter and discoloration prior to administration.
- Mechanism of Action Lanadelumab is a fully human monoclonal antibody that selectively binds to and inhibits plasma kallikrein. By inhibiting this enzyme, it prevents the cleavage of high-molecular-weight kininogen to bradykinin, thereby reducing the frequency of angioedema attacks associated with HAE.
- Safety and Warnings Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported. Injection Site Reactions: Localized pain, erythema, swelling, or induration at the injection site are common. Thrombosis: Thrombotic events have been reported in patients receiving lanadelumab.
- Adverse Reactions and Clinical Research Adverse Reactions: The most common adverse reactions include injection site reactions, nausea, vomiting, and arthralgia. Clinical Research: In pivotal clinical trials, lanadelumab significantly reduced the rate of acute angioedema attacks compared to placebo without inducing significant resistance.
- Drug Interactions No formal drug interaction studies have been conducted. Lanadelumab is primarily metabolized via non-specific proteolytic degradation, and no clinically significant drug-drug interactions are expected.
- Pharmaceutical Information Composition: Active ingredient is lanadelumab. Excipients include L-histidine, L-histidine hydrochloride monohydrate, L-arginine, sucrose, polysorbate 80, and water for injection. Appearance: Clear to slightly opalescent, colorless to pale yellow liquid. Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
Takhzyro Lanadelumab Injection
Brand Name: 达泽优 ®（Takhzyro® ）
Generic Name: Lanadelumab
Strength: 300mg/2mL (150mg/mL), single-dose vial, 1 vial per box
Manufacturer: Catalent Indiana, LLC / Vetter Pharma-Fertigung GmbH & Co. KG
Marketing Authorization Holder: Takeda Pharmaceutical Company Limited
Approval Date in China: 2020
Registration Number: 国药准字SJ20200025
Storage: Store refrigerated at 2°C–8°C in original carton to protect from light; do not freeze or shake. Can be stored below 25°C for a maximum of 14 days once removed from refrigeration, and cannot be put back into refrigeration afterward. Refer to the full package insert for detailed storage specifications.
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