ACTAIR

What it is

ACTAIR is a sublingual tablet containing a mixture of American and European house dust mite allergen extracts. The tablets contain a 50% mixture of allergen extracts from European house dust mites (Dermatophagoides pteronyssinus) and American house dust mites (Dermatophagoides farinae), with each tablet containing 100 IR or 300 IR. The IR (Index of Reactivity) unit measures 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

The treatment is composed of an initiation phase with a 3-day dose escalation and a continuation phase. During initiation, the dose is increased over three days: Day 1 requires one 100 IR tablet, Day 2 requires two 100 IR tablets taken simultaneously, and Day 3 requires one 300 IR tablet. The dose-escalation period may be prolonged when considered necessary by the physician. The continuation dose for adults, adolescents and children is 300 IR daily. Tablets should be placed under the tongue until complete disintegration (at least 2 minutes) and then swallowed, with food or beverage not taken for the following 5 minutes.

Key safety warnings

Severe allergic reactions including severe laryngopharyngeal disorders or systemic allergic reactions may occur with sublingual allergen immunotherapy, and patients should be made aware of the signs and symptoms of severe allergic reactions. Severe allergic reactions may be treated with adrenaline (epinephrine), and patients should discontinue treatment and seek immediate medical care in case of severe allergic reactions. Asthma status should be carefully evaluated before starting 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 duration of ACTAIR treatment. Abrupt discontinuation of asthma controller medication after initiation of ACTAIR treatment is not recommended. Cases of eosinophilic oesophagitis have been reported in association with ACTAIR treatment and other sublingual immunotherapies; if severe or persistent gastroesophageal symptoms including dysphagia or chest pain occur, ACTAIR should be interrupted and patients evaluated by their physician, with treatment only resumed upon physician instruction. Patients with cardiac disease may be at increased risk in case of systemic allergic reactions to allergen immunotherapy, and this should be considered prior to initiating ACTAIR. Patients taking beta-adrenergic blockers may be unresponsive to usual doses of adrenaline used to treat serious systemic reactions, as beta-adrenergic blockers antagonise the cardiostimulating and bronchodilating effects of adrenaline.

Contraindications

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

Regulatory history

ACTAIR Initiation Treatment (100 IR & 300 IR sublingual tablets) and ACTAIR Continuation Treatment (300 IR sublingual tablets) were first registered on the ARTG on 15 April 2016.