TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML [SIN17511P]
Active ingredients: TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML
Last updated 9 June 2026
Product Info
TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML
[SIN17511P]
Product information
Active Ingredient and Strength | LANADELUMAB - 300 MG/2 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | VETTER PHARMA-FERTIGUNG GMBH & CO KG (SCHÜTZENSTRASSE) - GERMANY |
Registration Number | SIN17511P |
Licence Holder | TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B06AC05 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic Indications
TAKHZYRO is indicated for routine prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and paediatric patients aged 2 years and older (see Clinical Studies, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Dosing
4.2 Posology and Method of Administration
Posology
Adult Patients
The recommended dose is 300 mg administered subcutaneously every 2 weeks (q2wks). A dosing interval of 300 mg every 4 weeks (q4wks) may be considered in patients who are well-controlled (e.g., attack free) for 6 months on treatment (see Pharmacodynamic Properties, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Special Patient Populations
Elderly Patients
No dose adjustment is required for patients above 65 years of age (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Pediatric Patients
12 to <18 years
The recommended dose is 300 mg administered subcutaneously q2wks. A dosing interval of 300 mg q4wks may be considered in patients who are well-controlled (e.g., attack free) for 6 months on treatment (see Pharmacodynamic Properties, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
6 to <12 years
The recommended dose is 150 mg administered subcutaneously q2wks. A dosing interval of 150 mg q4wks may be considered if the patient is well-controlled (e.g., attack free) for 26 weeks (see Pharmacodynamic Properties, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
2 to <6 years
The recommended dose is 150 mg administered subcutaneously q4wks (see Pharmacodynamic Properties, 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
The safety and efficacy of TAKHZYRO in paediatric patients < 2 years of age have not been studied.
Impaired Renal Function
No dedicated study has been conducted in subjects with renal impairment (see Pharmacokinetic Properties, 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Impaired Hepatic Function
No dedicated study has been conducted in subjects with hepatic impairment.
Method of Administration
Adult Patients and Paediatric Patients (12 to <18 Years)
For Single-dose 2 mL Prefilled Syringe:
TAKHZYRO is administered subcutaneously only.
TAKHZYRO is provided as a ready-to-use solution in a single-dose prefilled syringe.
Inspect the prefilled syringe for any damage. TAKHZYRO is supplied as a colourless to slightly yellow solution, appearing either clear or slightly opalescent. Do not use the prefilled syringe if the solution appears discoloured or contains visible particles. Avoid vigorous agitation of the prefilled syringe.
TAKHZYRO is intended for self-administration or administration by a healthcare provider or caregiver. The patient or caregiver should be trained by a healthcare professional.
Inject TAKHZYRO subcutaneously into the abdomen or thigh. Inject subcutaneously into the upper arm only if a healthcare provider or caregiver is giving the injection. Healthcare providers, caregivers or patients should inject the complete dose as prescribed.
For detailed instructions on the administration of TAKHZYRO using the prefilled syringe (see Instructions for Use/Handling, 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
If a dose of TAKHZYRO is missed, instruct the patient to administer the dose as soon as possible, ensuring at least 10 days between the doses.
Paediatric Patients (2 to <12 years)
For Single-dose 1 mL Prefilled Syringe:
TAKHZYRO is administered subcutaneously only.
TAKHZYRO is provided as a ready-to-use solution in a single-dose prefilled syringe.
TAKHZYRO is supplied as a colourless to slightly yellow solution, appearing either clear or slightly opalescent. Do not use the prefilled syringe if the solution appears discoloured or contains visible particles. Avoid vigorous agitation of the prefilled syringe.
TAKHZYRO is intended for administration by a healthcare provider or caregiver. The caregiver should be trained by a healthcare professional.
Inject TAKHZYRO subcutaneously into the abdomen, thigh, or upper arm. The complete dose should be injected as prescribed.
For detailed instructions on the administration of TAKHZYRO using the prefilled syringe (see Instructions for Use/Handling, 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
If a dose of TAKHZYRO is missed, instruct the caregiver to administer the dose as soon as possible, ensuring at least 10 days (6 to <12 years) and at least 24 days (2 to <6 years) between the doses.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.