ACARIZAX

What it is

ACARIZAX is a sublingual tablet containing a 50% mixture of house dust mite allergen extracts from European house dust mites (Dermatophagoides pteronyssinus) and American house dust mites (Dermatophagoides farinae). The medicine is available in two formulations: Initiation Treatment sublingual tablets containing 100 IR or 300 IR, and Continuation Treatment sublingual tablets containing 300 IR. IR (Index of Reactivity) is a unit defined to measure the allergenicity of an allergen extract.

Approved indications

— Treatment of house dust mite allergic rhinitis with or without conjunctivitis in adults, adolescents and children 5 years and over diagnosed with house dust mite allergy.

Dosing overview

ACARIZAX treatment comprises an initiation phase with a 3-day dose escalation and a continuation phase. During initiation, one 100 IR tablet is taken on Day 1, two 100 IR tablets are placed under the tongue simultaneously on Day 2, and one 300 IR tablet is taken on Day 3. The dose escalation period may be prolonged when considered necessary by the physician according to the patient's condition. The maintenance dose for adults, adolescents and children is 300 IR daily. Tablets should be taken during the day in an empty mouth, placed under the tongue until complete disintegration (at least 2 minutes) and then swallowed, with no food or beverage consumed for the following 5 minutes. The dosage is the same for adults, adolescents and children aged 5 years and over.

Key safety warnings

Severe allergic reactions including severe laryngopharyngeal disorders or systemic allergic reactions may occur with ACARIZAX, and patients should be made aware of the signs and symptoms of such reactions. It is recommended that the first tablet of ACARIZAX is taken under medical supervision and that the patient is monitored for 30 minutes. The asthma status should be carefully evaluated before starting ACARIZAX therapy, as asthma is a known risk factor for severe systemic allergic reactions, and patients with associated asthma should be controlled at initiation and during all the duration of ACARIZAX treatment. Patients with cardiac disease may be at increased risk in case of systemic allergic reactions and this should be taken into consideration prior to initiating ACARIZAX. Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of adrenaline used to treat serious systemic reactions, including anaphylaxis, as beta-adrenergic blockers antagonise the cardiostimulating and bronchodilating effects of adrenaline. Cases of eosinophilic oesophagitis have been reported in association with ACARIZAX treatment, and if severe or persistent gastroesophageal symptoms including dysphagia or chest pain occur, ACARIZAX should be interrupted and the patient evaluated by their physician.

Contraindications

ACARIZAX is contraindicated in patients with hypersensitivity to any excipients, and in those with severe, uncontrolled or unstable asthma (FEV1 < 80% of predicted value) or severe exacerbation of asthma within the previous 3 months. It is contraindicated in patients with active or poorly controlled autoimmune disease, immune defects, immunodeficiencies or immunosuppression or malignant neoplasia with current disease relevance. ACARIZAX is contraindicated in patients with severe oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis. Initiation of allergen immunotherapy treatment during pregnancy is contraindicated.

Regulatory history

ACARIZAX was approved by the TGA for registration on 21 July 2016 and subsequently entered onto the Australian Register of Therapeutic Goods on 1 August 2016. The TGA found no objections on quality grounds for ACARIZAX.