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Allergen immunotherapy (sublingual) Pregnancy: Section 4.6: 'There is no data on the clinical experience for the use of ITULAZAX in pregnant women. Animal studies do not indicate increased risk to the foetus. Treatment with ITULAZAX should not be initiated during pregnancy. If pregnancy occurs during treatment, the treatment may continue after evaluation of the general condition (including lung function) of the patient and reactions to previous administration of ITULAZAX. In patients with pre-existing asthma close supervision during pregnancy is recommended.' Breastfeeding: 'No clinical data are available for the use of ITULAZAX during lactation. No effects on the breastfed infants are anticipated.' Fertility: 'There is no clinical data with respect to fertility for the use of ITULAZAX. In a repeat dose toxicity study in naïve mice no effects were observed in the reproductive organs of both genders.'

Tree pollen extracts

Brand names: Itulazax

Tree pollen extracts are standardised allergen preparations used for allergen immunotherapy in patients with tree-pollen-driven allergic rhinitis or conjunctivitis not adequately controlled by standard treatment.

Adult dose

Dose: Treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group, in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE) - Itulazax: Adults: one sublingual lyophilisate (12 SQ-Bet) daily.
Route: Sublingual (lyophilisate placed under the tongue, where it disperses). The first sublingual lyophilisate should be taken under medical supervision and the patient monitored for at least half an hour. Specialist-initiated: 'ITULAZAX treatment should be initiated by physicians with experience in treatment of allergic diseases.'
Frequency: Once daily. Initiate outside the pollen season and continue during the tree pollen season; clinical effect has been demonstrated when treatment is started at least 16 weeks before the expected start of the tree (birch homologous group) pollen season and continued throughout the season (no clinical data for an in-season start). International guidelines refer to a treatment period of 3 years for allergy immunotherapy to achieve disease modification; if no improvement is observed during the first year of treatment, there is no indication for continuing.
PRODUCT AND SCOPE: this entry reproduces the UK SPC for ONE product only - ITULAZAX 12 SQ-Bet sublingual lyophilisate (standardised allergen extract of pollen from white birch, Betula verrucosa; 12 SQ-Bet per sublingual lyophilisate; Bet v 1 content 194 micrograms on average per lyophilisate - SPC section 2). The SPC indication covers the BIRCH HOMOLOGOUS GROUP only: Betula verrucosa (birch), Alnus glutinosa (alder), Carpinus betulus (hornbeam), Corylus avellana (hazel), Quercus alba (oak) and Fagus sylvatica (beech). Other tree-pollen allergens, other allergen products, units and schedules are not covered here. ADMINISTRATION (SPC 4.2): take with dry fingers from the blister unit immediately after opening and place under the tongue, where it will disperse; avoid swallowing for approximately 1 minute; do not take food or beverages for the following 5 minutes. INTERRUPTION: if treatment is interrupted for up to 7 days it can be resumed by the patient; if interrupted for more than 7 days, contact a physician before resuming. SPECIAL POPULATIONS: elderly - clinical experience in patients 65 years or over is limited; children below 5 years - not established and ITULAZAX is not intended for them (see paedDose). SPC 4.4 points that affect the regimen: in patients with asthma and an acute respiratory tract infection, postpone initiation until the infection has resolved; in severe oral inflammation (e.g. oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery including dental extraction or tooth loss, postpone initiation and temporarily interrupt ongoing treatment to allow healing of the oral cavity; in patients with severe or persistent gastro-oesophageal symptoms such as dysphagia or dyspepsia, interrupt ITULAZAX and seek medical evaluation (eosinophilic oesophagitis reported). Some sections of the product information we used were incomplete — check the full SPC. The SPC prints no maximum dose.

Paediatric dose

Dose: Children 5-17 years (moderate-to-severe allergic rhinitis and/or conjunctivitis induced by birch homologous group pollen): one sublingual lyophilisate (12 SQ-Bet) daily - the same posology as adults (SPC: 'The posology to be used in children (5-17 years) is the same as in adults').
Route: Sublingual (placed under the tongue)
Frequency: Once daily, as for adults
SPC: clinical experience in treatment of allergic rhinitis and/or conjunctivitis with ITULAZAX in children below 5 years of age has not been established, and ITULAZAX is not intended for children below 5 years of age - no dose is given for them. Initiate under a physician experienced in treating allergic diseases, with the first lyophilisate taken under medical supervision and the patient monitored for at least half an hour.

Dose adjustments

Renal

Not stated in the product information we used — check the full SPC.

Hepatic

Not stated in the product information we used — check the full SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to any of the excipients (SPC section 6.1)
  • Patients with FEV1 < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment
  • Patients who have experienced a severe asthma exacerbation within the last 3 months prior to initiation
  • Patients with uncontrolled asthma within the last 3 months prior to initiation
  • Patients with active systemic autoimmune disorders (unresponsive to treatment) and patients with immune defects, immunodeficiencies or immunosuppression
  • Patients with malignant neoplasia with current disease relevance
  • Patients with acute severe oral inflammation or oral wounds

Side effects

  • Mild to moderate local allergic reactions within the first few days of treatment that disappear within a few months (in many cases within a week or two); usually start within 10 minutes of intake and abate within an hour
  • Oral pruritus in 38% of patients, throat irritation in 29% and tongue pruritus in 13%
  • Very common: ear pruritus, throat irritation, oedema mouth, oral pruritus, paraesthesia oral, tongue pruritus
  • Common: oral allergy syndrome; dysgeusia; symptoms of allergic conjunctivitis; cough, dry throat, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema, pharyngeal paraesthesia, rhinitis; abdominal pain, diarrhoea, dyspepsia, dysphagia, gastro-oesophageal 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
  • Uncommon: laryngeal oedema, throat tightness; glossitis, lip blister, mouth ulceration, oesophageal irritation; angioedema
  • Not known: anaphylactic reaction, eosinophilic oesophagitis

Interactions

  • No interaction trials have been conducted in humans and no potential drug interactions have been identified from any source (SPC 4.5)
  • Concomitant symptomatic anti-allergic medications may increase the patient's tolerance level to immunotherapy - consider this at discontinuation of such medications
  • Adrenaline for severe systemic allergic reactions: effects may be potentiated in patients treated with tricyclic antidepressants, MAOIs and/or COMT inhibitors with possible fatal consequences, and reduced in patients treated with beta-blockers
  • Simultaneous vaccination: clinical experience is missing; vaccination may be given without interrupting ITULAZAX after medical evaluation of the patient's general condition

Monitoring

  • First sublingual lyophilisate under medical supervision, monitoring the patient for at least half an hour for any immediate side effect
  • On the first few days of at-home administration, adverse reactions not seen on the first day may occur - inform patients which reactions to expect and how to manage them
  • Stop and contact a physician immediately for severe systemic allergic reactions, severe asthma exacerbation, severe pharyngeal oedema, difficulty in swallowing or breathing, changes in voice, hypotension or a feeling of fullness in the throat
  • Patients with asthma must be told to seek medical attention immediately if their asthma deteriorates suddenly; ITULAZAX has not been studied in severe and/or uncontrolled asthma
  • Patients who previously had a systemic allergic reaction to subcutaneous tree pollen immunotherapy: consider initiation carefully and have measures to treat reactions available
  • Patients with cardiac disease may be at increased risk in severe systemic allergic reactions; prescribe with caution in severe cardiovascular disease
  • Autoimmune diseases in remission: limited data - prescribe with caution
  • Consider allergy pharmacotherapy (e.g. antihistamines) for significant local adverse reactions
  • Review for improvement after the first year of treatment; no indication to continue if no improvement

Clinical monograph

How it works

Repeated controlled exposure to the relevant tree pollen allergens modifies the immune response, promoting tolerance and reducing allergic reactivity over time.

Prescribing in practice

  • There is a risk of systemic allergic reactions including anaphylaxis, so treatment must be supervised by appropriately trained staff with resuscitation facilities available, particularly for the first dose.
  • It is generally contraindicated in poorly controlled or severe asthma, which increases the risk of serious reactions.
  • Beta-blockers may worsen and complicate the management of any anaphylactic reaction and should be reviewed before treatment.

Monitoring

Observe the patient for a period after administration for systemic and local allergic reactions, especially during initiation.

Counselling the patient

  • You may be asked to wait under observation after each dose in case of a reaction.
  • Tell your team if your asthma is unstable or your symptoms worsen.
  • Carry any prescribed emergency treatment and know how to recognise a serious reaction.

Evidence & guidelines

Allergen immunotherapy is recommended for selected patients with troublesome allergic rhinitis inadequately controlled by standard pharmacotherapy, as reflected in UK and specialist allergy guidance.

Reference: SmPC; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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