ORALAIR

What it is

ORALAIR is an allergen pollen extract of 5 grasses presented as sublingual tablets in two treatment phases: Initiation Treatment Tablets in 100 IR and 300 IR strengths, and Continuation Treatment Tablets in 300 IR strength. The allergen extract contains grass pollen from Cocksfoot, Sweet vernal grass, Rye grass, Meadow grass and Timothy. The IR (Index of Reactivity) unit measures the allergenicity of the allergen extract, defined by its capacity to induce a specific wheal diameter in sensitised patients on skin prick-test.

Approved indications

— Treatment of grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 with clinically relevant symptoms, confirmed by a positive cutaneous test and/or a positive titre of the specific IgE to the grass pollen.

Dosing overview

The therapy comprises an initiation treatment with a 3-day dose escalation followed by a continuation treatment. During initiation, the dose is increased over three days: 1 tablet of 100 IR on day 1, 2 tablets of 100 IR simultaneously on day 2, and 1 tablet of 300 IR on day 3. For maintenance treatment, the dose for adults, adolescents and children is 300 IR daily, continued with one ORALAIR 300 IR sublingual tablet per day until the end of the pollen season. Treatment should be initiated each year about 4 months before the expected onset of the pollen season and must be maintained until the end of the pollen season. Tablets should be placed under the tongue until complete dissolution (at least 2 minutes) and then swallowed. It is recommended to take the tablets during the day in an empty mouth, and food and beverage should not be taken for the following 5 minutes.

Key safety warnings

Severe allergic reactions including severe laryngopharyngeal disorder or systemic allergic reactions can occur with allergen immunotherapy, and patients should seek immediate medical care and discontinue therapy should these occur. Asthma is a known risk factor for severe systemic allergic reactions; asthma status should be carefully evaluated before starting therapy, and patients with associated asthma should be controlled at initiation and during all the duration of ORALAIR treatment. Patients with cardiovascular disease may be at increased risk in case of systemic allergic reactions and this should be taken into consideration prior to initiating ORALAIR. Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of adrenaline used to treat serious systemic reactions, as beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of adrenaline. Mild or moderate local allergic reactions in the oropharyngeal area (such as oral pruritus, throat irritation and ear pruritus) may be expected during therapy. Eosinophilic esophagitis has been reported in association with ORALAIR; if severe or persistent gastrointestinal symptoms including dysphagia or chest pain occur during treatment, ORALAIR should be interrupted and the patient evaluated by their physician.

Contraindications

ORALAIR is contraindicated in patients with hypersensitivity to any of the excipients, severe uncontrolled or unstable asthma (FEV1 < 70% of predicted value) or severe exacerbation of asthma within the previous 3 months, active or poorly controlled autoimmune disease, immune defects, immunodeficiencies or immunosuppression or malignant neoplastic diseases with current disease relevance, and severe oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis. Initiation of allergen immunotherapy treatment during pregnancy is contra-indicated.

Regulatory history

ORALAIR was first listed on the ARTG on 3 May 2011 with two registrations: ARTG 167565 for Initiation Treatment Sublingual Tablets 100IR & 300IR and ARTG 167566 for Continuation Treatment Sublingual Tablets 300IR. The TGA approved ORALAIR Sublingual Tablets for the treatment of grass pollen allergic rhinitis with or without conjunctivitis on 19 April 2011, following a submission for a new route of administration and dosage form. The TGA evaluation found that sublingual immunotherapy with natural extract tablets such as ORALAIR demonstrated a high level of evidence for efficacy in both adult and paediatric populations for treating grass pollen allergic rhinitis and was considered generally safer than traditional subcutaneous immunotherapy.