Acarizax

Adults 18-65 yr diagnosed by clinical history & +ve test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ at least 1 of the following conditions: persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication; house dust mite allergic asthma not well controlled by inhaled corticosteroids & associated w/ mild to severe house dust mite allergic rhinitis. Adolescents 12-17 yr diagnosed by clinical history & +ve test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.

1 oral lyophilisate (12 SQ-HDM) daily.

Should be taken on an empty stomach: Take w/ dry fingers immediately after opening blister & place under the tongue. Avoid swallowing for approx 1 min. Do not take food & beverage for the following 5 min.

Hypersensitivity. Patients w/ FEV₁ <70% of predicted value (after adequate pharmacological treatment) at treatment initiation. Patients who have experienced severe asthma exacerbation w/in the last 3 mth. Patients w/ active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases w/ current disease relevance. Patients w/ acute severe oral inflammation or oral wounds. Postpone treatment initiation in patients w/ asthma & experiencing acute resp tract infection until infection has resolved.

No indication for continuing treatment if no improvement is observed during the 1st yr of treatment. 1st oral lyophilisate should be taken under medical supervision & patient monitored for at least ½ hr. Carefully evaluate patient's asthma status before treatment initiation. Not intended to treat acute asthma exacerbations. Initially use as add-on therapy & not as substitute of pre-existing asthma medication. Abrupt discontinuation of asthma controller medication after initiation of Acarizax treatment is not recommended. Discontinue treatment in case of severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing/breathing, voice changes, hypotension or feeling of throat fullness. Carefully consider initiation in patients who have previously had systemic allergic reaction to SC house dust mite immunotherapy. Postpone treatment initiation & temporarily interrupt ongoing treatment in patients w/ severe oral inflammation (eg, oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery, including dental extraction, or following tooth loss. Local allergic reactions are to be expected during treatment period. Reports of eosinophilic esophagitis. Interrupt treatment in patients w/ severe or persisting gastroesophageal symptoms eg, dysphagia or dyspepsia. Caution in patients w/ cardiac disease; autoimmune diseases in remission. May contain trace amounts of fish protein. Treatment should not be initiated during pregnancy. If pregnancy occurs during treatment, treatment may continue after evaluation of patient's general condition (including lung function) & reactions to previous administration. Close supervision during pregnancy is recommended in patients w/ pre-existing asthma. Not intended for treatment of allergic rhinitis in childn <12 yr & allergic asthma in childn <18 yr. Not intended for use in adults >65 yr.

Nasopharyngitis; ear pruritus; throat irritation; lip/mouth oedema, oral pruritus. Bronchitis, pharyngitis, rhinitis, sinusitis; dysgeusia; eye pruritus; asthma, cough, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema; abdominal pain, diarrhoea, dysphagia, dyspepsia, GERD, glossodynia, glossitis, lip pruritus, mouth ulceration, oral pain, tongue pruritus, nausea, oral discomfort, oral mucosal erythema, oral paraesthesia, stomatitis, tongue oedema, vomiting; pruritus, urticaria; chest discomfort, fatigue.

Concomitant therapy w/ symptomatic anti-allergic medications may increase patient's tolerance level to immunotherapy.

Antihistamines & Antiallergics

V01AA03 - house dust mites ; Belongs to the class of allergen extracts. Used as antigenic substances capable of producing immediate-type hypersensitivity.

P₁S₁S₃