ANDEMBRY

What it is

ANDEMBRY is garadacimab 200 mg solution for subcutaneous injection, available in pre-filled pen and pre-filled syringe formulations with 1.2 mL of solution per single dose. Garadacimab is a recombinant, fully human, monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovarian cells. Garadacimab is a specific inhibitor of activated FXII and binds to the catalytic domain of activated Factor XII to potently inhibit its catalytic activity. By inhibiting FXIIa, it prevents the activation of prekallikrein to kallikrein and the generation of bradykinin, which blocks the cascade of events leading to hereditary angioedema attacks.

Approved indications

— Routine prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 years and older with C1-INH HAE (C1-esterase inhibitor deficiency or dysfunction).

Dosing overview

The recommended dose of ANDEMBRY is an initial loading dose of 400 mg administered subcutaneously as two 200 mg injections on the first day of treatment followed by a monthly dose of 200 mg. ANDEMBRY is intended for subcutaneous administration only. ANDEMBRY should be administered into the abdomen or thigh; if administered by somebody else, the upper arm can also be used.

Key safety warnings

ANDEMBRY is not intended for treatment of acute HAE attacks; in case of breakthrough HAE attack, individualised treatment should be initiated with an approved rescue medicine. Hypersensitivity reactions have been observed; signs and symptoms may include hives (local and generalised), tightness of the chest, difficulty breathing, wheezing, hypotension, and/or anaphylaxis during or after injection. In case of severe hypersensitivity, appropriate treatment should be instituted immediately and ANDEMBRY administration discontinued. Garadacimab can prolong activated partial thromboplastin time (aPTT) due to an interaction with the aPTT assay, as inhibition of plasma FXIIa can prolong aPTT in this assay. None of the increases in aPTT in patients treated with garadacimab were associated with bleeding adverse events. No studies have been conducted in patients with hepatic impairment and the safety of garadacimab in such patients has not been established.

Contraindications

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

PBS listing

ANDEMBRY 200 mg in 1.2 mL pre-filled pen is listed on the PBS with 4 items under authority required restriction, at an ex-manufacturer price of A$30012.63.

Regulatory history

ANDEMBRY garadacimab 200 mg was first listed on the ARTG on 14 January 2025, with both pre-filled syringe and pre-filled pen formulations registered. The TGA approved ANDEMBRY on 9 January 2025 for routine prevention of recurrent hereditary angioedema attacks in patients aged 12 years and older with C1-INH HAE. The product was granted orphan drug designation and evaluated under the standard prescription medicines registration process. The PBAC recommended ANDEMBRY in November 2024 for prophylaxis of recurrent HAE attacks Types I and II for General Schedule Authority Required listing. This medicinal product is subject to additional monitoring in Australia.