Application Scope

For prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older

Characteristics

Ingredients:
- Active ingredient: Lanadelumab (recombinant human monoclonal antibody)
- Excipients: (as per local label) formulation components for stability (refer to full label for exact excipients).
Properties: A clear to slightly opalescent, colorless to pale-yellow solution for injection. Supplied as single-use vial(s).
Packaging Specification: 300 mg / 2 mL (150 mg/mL), 1 vial per box (single-use)
Storage: Refrigerate at 2 °C – 8 °C (36 °F – 46 °F). Do not freeze. Protect from light. Keep in original carton until use.
Expiry Date: Refer to the vial/outer carton. Typical shelf life per label: 36 months from manufacture (see packaging).
Executive Standard: Manufactured and released according to regulatory requirements for therapeutic biological products (NMPA/ICH/GMP standards as applicable).
Approval Number: China registration / approval: SJ20200025 (registered/imported product).
Date of Revision: First approval in China: Dec 4, 2020; consult carton/label for latest revision date.
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc. (Marketing/MAH in China / Takeda local authorization). Imported product; local authorized entity per label.

Guidelines for the Use of lanadelumab-flyo injection

Dosage and Administration:
- Recommended Dose:
  - Initial / starting regimen: 300 mg subcutaneously every 2 weeks.
  - Alternative maintenance option: 300 mg every 4 weeks may be considered for patients who have been well controlled (e.g., attack-free) for >6 months.
- Administration:
- Subcutaneous injection only. Administer as single 300 mg injection (use appropriate volume/vial). Can be given by healthcare professional or trained patient/caregiver according to local practice and training. Follow preparation and aseptic technique in label.
- Missed Dose:
- If a scheduled dose is missed, administer as soon as possible and then resume the previous dosing schedule. Do not double doses. (Refer to local prescribing information for detailed guidance.)
Adverse Reactions:
- Common Adverse Reactions:
  - Injection site reactions (pain, erythema, bruising) — most common.
  - Upper respiratory tract infections, headache, myalgia, arthralgia, injection site pain. Frequency varies by regimen.
- Serious Adverse Reactions:
  - Hypersensitivity reactions (including anaphylaxis) — rare but possible.
  - As with most biologics, monitor for severe allergic reactions; discontinue and treat if they occur.
Contraindications: Known hypersensitivity to lanadelumab or any excipient in the formulation.
Precautions:
- Monitor for signs of hypersensitivity after injection.
- Limited data in certain special populations — consult local label for pregnancy, lactation, pediatric (12–17), renal/hepatic impairment guidance.
- Counsel patients to seek urgent care if they experience signs of a severe allergic reaction.

Lanadelumab Interactions

No clinically significant pharmacokinetic drug–drug interactions identified to date. Monitor concomitant immunomodulatory therapies per standard clinical practice. Refer to full prescribing information for detailed interaction data. (Some drug-interaction databases list theoretical interactions; check label / DrugBank for specifics.)

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.