ALUSTAL

What it is

ALUSTAL is prepared from freeze-dried allergen extracts adsorbed onto aluminium hydroxide gel. The product contains pollen extract of five grasses: Dactylis glomerata, Poa pratensis, Lolium perenne, Anthoxanthum odoratum and Phleum pratense pollen extracts. Each 5 mL vial contains specific allergen extract(s) in suspension and are available in various concentrations. Three concentrations are available: yellow cap (0.1 IR/mL), green cap (1.0 IR/mL) and blue cap (10.0 IR/mL). The IR (Index of Reactivity) unit measures the allergenicity of an allergen extract, defined by skin prick-testing standardisation.

Approved indications

— Type 1 allergy presenting as seasonal or perennial rhinitis. — Type 1 allergy presenting as conjunctivitis. — Type 1 allergy presenting as rhinoconjunctivitis with or without associated asthma.

Dosing overview

Treatment is given in two phases: an initiation phase with dose escalation (weekly injections) and a maintenance phase with constant dose (monthly injections). During the initiation phase, the product is injected by the deep subcutaneous route at progressively escalating dosage, starting with 0.1 mL of 0.1 IR/mL concentration in week one and escalating through the 1 IR/mL and 10 IR/mL concentrations over 14 to 23 weeks to a maximum tolerated dose of 0.8 mL. During the maintenance phase, the highest tolerated dose (maximum 0.8 mL) of 10 IR/mL concentration is repeated at intervals of two weeks, then monthly or at longer intervals not exceeding six weeks between successive injections. As a general rule, treatment with ALUSTAL should be continued for between three and five years.

Key safety warnings

Treatment must be performed in the presence of or by a physician with experience in allergen immunotherapy and in conditions allowing immediate emergency treatment if necessary, including adrenaline. The patient should remain under medical supervision for 30 minutes after each injection. Severe allergic reactions including systemic allergic reactions may occur, and patients should be made aware of the signs and symptoms of severe allergic reactions. Asthma is a known risk factor for severe systemic allergic reactions. Patients with associated asthma should be controlled at the initiation and during all the duration of treatment. 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. ALUSTAL contains four milligrams of aluminium per five millilitre vial, and risk of accumulation of aluminium into tissues should be kept in mind, especially in cases of renal insufficiency.

Contraindications

ALUSTAL is contraindicated in patients with hypersensitivity to any excipient. The medicine is contraindicated in patients with active or poorly controlled autoimmune disease, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance. ALUSTAL is contraindicated in patients with severe, uncontrolled or unstable asthma (FEV1 less than 70 percent of predicted value) or severe exacerbation of asthma within the last three months. Initiation of allergen immunotherapy treatment is contraindicated during pregnancy. ALUSTAL is contraindicated in patients with renal insufficiency, those on treatment with beta-blockers and patients with a bleeding tendency.

Regulatory history

ALUSTAL pollen extract of five grasses maintenance (10 IR/mL) was first listed on the ARTG on 3 October 2006. ALUSTAL pollen extract of five grasses initial treatment was also first listed on the ARTG on 3 October 2006.