Molecule
Lanadelumab is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older. It is available as injection for subcutaneous use. MedsAcross supplies Lanadelumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TAKHZYRO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older. TAKHZYRO is a plasma kallikrein inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.
Source: US FDA prescribing information
Lanadelumab-flyo is a fully human monoclonal antibody (IgG1/κ-light chain) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.
Source: US FDA prescribing information
For subcutaneous use only. Recommended Dosage: Adult and pediatric patients 12 years of age and older: administer 300 mg every 2 weeks by the patient or caregiver. Dosing interval every 4 weeks may be considered in some patients. Pediatric patients 6 years to less than 12 years of age: administer 150 mg every 2 weeks by a healthcare provider or caregiver. Pediatric patients 2 years to less than 6 years of age: administer 150 mg every 4 weeks by a healthcare provider or caregiver. See Full Prescribing Information for Preparation and Administration Instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
Source: US FDA prescribing information
The most common adverse reactions (≥10%) are injection site reactions, upper respiratory infections, headache, rash, dizziness, diarrhea, and myalgia.
Source: US FDA prescribing information
No dedicated drug interaction studies have been conducted.
Source: US FDA prescribing information
Store the prefilled syringes refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Keep the prefilled syringe in the original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Lanadelumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Takhzyro 150 mg/1 mL injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
| Takhzyro 300 mg/2 mL injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Lanadelumab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Lanadelumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lanadelumab, including Takhzyro.
Yes. The US FDA first approved Lanadelumab on 23 August 2018, according to Drugs@FDA.
Yes. Lanadelumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Lanadelumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Lanadelumab is classified under ATC code B06AC05 (Lanadelumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.