Takhzyro Lanadelumab Injection

1. Indications and Usage
Hereditary Angioedema (HAE):
Indicated for prophylaxis to prevent attacks of HAE in patients 12 years of age and older.
2. Dosage and Administration
Recommended Dosage:
Initial Dosage: 300 mg (2 mL) administered subcutaneously once every 2 weeks.
Maintenance Dosage Adjustment: For patients who have not experienced an HAE attack for at least 6 months, the dosage may be reduced to 300 mg once every 4 weeks.
Administration Instructions:
Route: Administer by subcutaneous injection into the abdomen, thigh, or upper arm.
Preparation: Lanadelumab is a ready-to-use solution supplied in single-dose vials; no reconstitution or dilution is required.
Handling: Allow the vial to reach room temperature (approx. 15 minutes) before use. Do not shake vigorously.
3. Mechanism of Action
Plasma Kallikrein Inhibitor:
Lanadelumab is a human monoclonal antibody that selectively and potently inhibits plasma kallikrein.
Physiological Effect:
It binds to plasma kallikrein, inhibiting its proteolytic activity and reducing the excessive generation of bradykinin, the mediator responsible for the edema and pain associated with HAE attacks.
4. Safety and Warnings
Hypersensitivity Reactions:
Hypersensitivity reactions, including angioedema, urticaria, and rash, have been reported. If a hypersensitivity reaction occurs, discontinue lanadelumab and initiate appropriate therapy.
Vaccinations:
Ensure that patients are up to date with all age-appropriate vaccinations, especially against Streptococcus pneumoniae and Haemophilus influenzae type b, prior to initiating treatment.
5. Adverse Reactions
Most Common:
Injection site reactions (pain, erythema, bruising), upper respiratory tract infections, headache, rash, myalgia, dizziness, and diarrhea.
6. Drug Interactions
No Significant Interactions:
No formal drug interaction studies have been conducted. However, no clinically significant drug interactions have been identified to date.
7. Pharmaceutical Information
Chemical Description:
Lanadelumab is a recombinant human IgG4 monoclonal antibody.
Storage and Handling:
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze or shake.
If needed, can be stored at room temperature up to 25°C (77°F) for up to 48 hours in the original carton.