TAKHZYRO

What it is

TAKHZYRO is lanadelumab supplied as a subcutaneous injection. It is a sterile, preservative-free solution supplied in a single-dose pre-filled syringe or a single-dose vial. Each pre-filled syringe contains either 300 mg of lanadelumab in 2 mL solution or 150 mg of lanadelumab in 1 mL solution, and each vial contains 300 mg of lanadelumab in 2 mL solution. Lanadelumab is a fully human monoclonal antibody (IgG1/κ-light chain) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lanadelumab inhibits active plasma kallikrein proteolytic activity without binding prekallikrein, the inactive precursor found in the circulation.

Approved indications

— Routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 2 years and older.

Dosing overview

TAKHZYRO therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE). TAKHZYRO is administered subcutaneously only and is provided as a ready-to-use solution that does not require additional reconstitution or dilution for administration.

Key safety warnings

TAKHZYRO should not be used to treat an acute attack. Patients and caregivers should continue to be prepared to treat attacks with acute HAE treatments when necessary. Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%). TAKHZYRO can increase activated partial thromboplastin time (aPTT) due to an interaction of TAKHZYRO with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by TAKHZYRO can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

TAKHZYRO 300 mg in 2 mL single-use pre-filled syringe is listed on the PBS with authority required restriction. The ex-manufacturer price is A$18,440.10.

Regulatory history

The 300 mg/2 mL vial was first approved on 30 January 2019, the 300 mg/2 mL pre-filled syringe on 15 June 2020, and the 150 mg/1 mL pre-filled syringe on 25 July 2024. PBAC recommended the product for hereditary angioedema in July 2021. PBAC recommended an extension of indication in November 2024 for preventative treatment of hereditary angioedema in patients aged less than 12 years. The product is subject to additional monitoring in Australia due to approval of an extension of indication, which will allow quick identification of new safety information.