PRESCRIBING INFORMATION – UK ONLY

ITULAZAX^® 12 SQ-Bet oral lyophilisate (tablet) for sublingual allergen immunotherapy, contains standardised allergen extract of pollen from white birch (Betula verrucosa).
Indications: The treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group in adults and children (5 years or older) with a clinical history of symptoms despite use of symptomrelieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE). The birch homologous group include: Betula verrucosa (birch), Alnus glutinosa (alder), Carpinus betulus (hornbeam), Corylus avellana (hazel), Quercus alba (oak), Fagus sylvatica (beech).
Posology and Administration: The recommended daily dose for adults and children (5 years or older) is one oral
tablet (12 SQ-Bet) to be placed under the tongue. The first tablet should be taken under medical supervision for at least
half an hour. Avoid swallowing for about 1 minute. Food and beverage should not be taken for the following 5 minutes.
Clinical effect during the tree (birch homologous group) pollen season has been demonstrated when treatment is
initiated at least 16 weeks prior to the expected start of the tree pollen season and continued throughout the season.
Treatment should be initiated by physicians with experience in the treatment of allergic diseases.
Contraindications: Hypersensitivity to excipients, malignancy or active systemic disorders affecting the immune system, severe oral inflammation, or oral wounds. Predicted FEV1<70% (after adequate pharmacologic treatment) at initiation of treatment. Severe asthma exacerbation or uncontrolled asthma within last 3 months prior to initiation.
Special Warnings and Precautions: Treatment should be discontinued, and a physician should be contacted immediately in case of severe systemic allergic reactions, severe asthma exacerbation, severe pharyngeal oedema, 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, mono amino oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers. Patients with cardiac disease may be at increased risk in case of severe systemic allergic reactions. Initiation in patients who have previously had a systemic allergic reaction to subcutaneous tree pollen allergy immunotherapy should be carefully considered. Asthma is a known risk factor for severe systemic reactions. In severe oral inflammation, oral wounds or following oral surgery or tooth loss, initiation of treatment should be postponed. In severe or persisting gastro-oesophageal symptoms, medical evaluation must be sought. ITULAZAX 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 of treatment and disappear within a few months (in many cases within a week or two). For most events, the reaction starts within 10 minutes after intake of ITULAZAX on each day of occurrence and abates within an hour. More severe local allergic reactions may occur. Systemic allergic reactions, including anaphylactic reactions, are known risks. Oral allergy syndrome can occur upon ingestion of certain raw vegetables, fruits, or nuts. Very common adverse reactions: ear pruritus, throat irritation, oedema mouth, oral pruritus, paraesthesia oral, tongue pruritus. Common: rhinitis, oral allergy syndrome, dysgeusia, cough, dry throat, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema, pharyngeal paraesthesia, abdominal pain, diarrhoea, dyspepsia, dysphagia, gastrooesophageal reflux disease, glossodynia, hypoaesthesia oral, lip oedema, lip pruritus, nausea, oral discomfort, oral mucosal blistering, stomatitis, swollen tongue, urticaria, chest discomfort, sensation of foreign body. Unknown: anaphylactic reaction, eosinophilic oesophagitis. 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 severe systemic or local allergic reactions.
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, SL6 1AF. Telephone: +44 (0)1189 037940.
Marketing Authorisation Number: PL 10085/0059.
Pack Size: 30 tabs.
NHS List Price: £80.12 per 30 tablet pack
Updated: July 2026. GB-IZX-2500007