ACARIZAX® 12 SQ-HDM sublingual lyophilisate (tablet) for allergy immunotherapy contains standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae. Indications: 1) Indicated in adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite (HDM) sensitisation (skin prick test and/or specific IgE) with at least one of these conditions: persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving medication, or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis. Patients’ asthma status should be carefully evaluated before the initiation of treatment. 2) Indicated in children (5-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
Posology and administration: The recommended dose for patients (5-65 years) is one sublingual lyophilisate (12 SQ-HDM) daily. The first tablet should be taken under medical supervision for at least half an hour. The daily dose is one tablet to be placed under the tongue. Avoid swallowing for about 1 minute. Food and beverage should not be taken for the following 5 minutes. Treatment should be initiated by physicians with experience in treatment of allergic diseases. (Allergic asthma: Use in children <18 years of age has not been established.)
Contraindications: Hypersensitivity to excipients. Predicted FEV1<70% (after adequate pharmacological treatment) at initiatio n of treatment. Severe asthma exacerbation within the last 3 months. Patients with asthma and experiencing an acute respiratory tract infection, initiation of treatment should be postponed. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance. Acute severe oral inflammation or oral wounds.
Special warnings and precautions: Asthma is a risk factor for severe systemic allergic reactions. ACARIZAX is not intended to treat acute asthma exacerbation and should initially be used as add on therapy. Abrupt discontinuation of asthma controller medication is not recommended. Treatment should be discontinued, and a physician should be contacted immediately in case of severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the
throat. One option for treating severe systemic allergic reactions is adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, MAOls and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers. Initiation in patients who have previously had a systemic allergic reaction to subcutaneous HDM immunotherapy should be carefully considered. Cas es of eosinophilic oesophagitis have been reported in association with treatment. In patients with severe or persisting gastro-oesophageal symptoms such as dysphagia or dyspepsia, treatment should be interrupted, and medical evaluation must be sought. There are additional precautions listed including regarding use in patients with oral inflammation or oral wounds, local allergic reaction, autoimmune diseases in remission. ACARIZAX may contain trace amounts of fish protein.
Interactions: Concomitant therapy with symptomatic anti-allergic medications may increase the tolerance level of the patient to immunotherapy.
Pregnancy and lactation: Treatment should not be initiated during pregnancy. No clinical data are available for use during lactation.
Undesirable effects: Expect mild to moderate local allergic reactions to occur within the first few days and subsiding with continued treatment (1-3 months). For most events, the reaction should be expected to start within 5 minutes after intake and abate after minutes to hours. More severe oropharyngeal allergic reactions may occur. Severe acute worsening of asthma symptoms and serious systemic allergic reactions, including anaphylaxis, have been reported. Hypertensive crisis has been reported following respiratory distress shortly after intake. Very common adverse reactions (≥1/10): nasopharyngitis, ear pruritus, throat irritation, lip oedema, mouth oedema, oral pruritus. Common (≥1/100 to <1/10): bronchitis, pharyngitis, rhinitis, sinusitis, dysgeusia, eye pruritus, asthma, cough, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema, abdominal pain, diarrhoea, dysphagia, dyspepsia, gastroesophageal reflux disease, 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. Consult the SmPC for details of adverse reactions.
Overdose: If doses higher than the recommended daily dose are taken, the risk of side effects may increase, including the risk of systemic allergic reactions or severe local allergic reactions. ATC Code: V01AA03
Legal Category: Prescription-Only Medicine (POM).
Marketing Authorisation Holder: ALK-Abelló A/S, Bøge Alle 6–8, DK-2970 Hørsholm, Denmark.
UK Office: ALK-Abelló Ltd, The Place, Bridge Avenue, Maidenhead, SL61AF
Marketing Authorisation Number: PL10085/0058.
NHS List Price: £80.12 per 30 tablets.
Updated: August 2026. GB-AZX-2500026