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Allergen extract birch pollen oral

Updated 2 Feb 2023 | Allergen Immunotherapy


Oral lyophilisate formation of birch pollen (Betula verrucosa) standardised allergen extract.

Drugs List

  • ITULAZAX 12 SQ-BET oral lyophilisate tablet
  • white birch pollen allergen extract 12 sq-bet oral lyophilisates sugar-free
  • Therapeutic Indications


    Allergic rhinitis and/or conjunctivitis - birch pollen

    Moderate to severe allergic rhinitis or conjunctivitis induced by pollen from the birch homologous group.

    The birch homologous group includes Betula verrucosa (birch), Alnus glutinosa (alder), Carpinus betulus (hornbeam), Corylus avellana (hazel), Quercus alba (oak) and Fagus sylvatica (beech).



    One oral lyophilisate (12 SQ-Bet) daily.

    Additional Dosage Information

    Contact a physician before resuming treatment if interruption occurs for more than 7 days.

    Taking anti-allergic medications concomitantly with birch pollen allergen extract may increase patient's tolerance level to immunotherapy. Therefore, this needs to be taken into consideration when discontinuing anti-allergic medications.


    Autoimmune disease
    Children under 18 years
    Acute severe oral inflammation
    FEV1 below 70% of predicted value at baseline
    Malignant neoplasm
    Oral wound
    Severe asthma
    Severe asthma exacerbation within 3 months prior to initiation

    Precautions and Warnings

    History of autoimmune disorder
    Patients over 65 years
    Cardiac disorder

    First dose should be given under medical supervision: Risk of anaphylaxis
    Treatment to be initiated and supervised by a specialist
    Contains fish-derived gelatine
    Monitor patient for 30 minutes after first administration
    Advise patient to seek medical advice if asthma seems to be worsening
    Consider antihistamines if severe local adverse reactions occur
    Discontinue if serious allergic or anaphylactic reaction occurs
    Advise patient not to swallow for 1 min or eat/drink for 5 mins after use
    Advise patient to contact the doctor immediately in the event of a reaction

    Treatment should be initiated outside of pollen season and continued during tree pollen season. Clinical effectiveness has been shown when treatment has been initiated 16 weeks prior to tree (birch homologous group) pollen season.

    Discontinue treatment and contact physician in cases 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. Onset of system symptoms can include flushing, pruritus, sense of heat, general discomfort and agitation/anxiety.

    Treatment should be postponed in asthmatic patients experiencing an acute respiratory tract infection.

    Consider treatment carefully for patients with a history of systemic allergic reaction to subcutaneous tree pollen allergy immunotherapy.

    Postpone or interrupt treatment if patient experiences severe oral inflammation such as oral lichen planus, mouth ulcers or thrush, oral wounds, oral surgery including dental extraction or tooth loss to allow healing of the oral cavity.

    Patients with severe or persistent gastro-oesophageal symptoms such as dysphagia or dyspepsia should seek medical evaluation.

    Pregnancy and Lactation


    Use birch pollen allergen extract with caution during pregnancy.

    The manufacturer does not recommend the use of birch pollen allergen extract during pregnancy. If pregnancy occurs during treatment, the treatment can be continued after an evaluation of lung function. Patients with pre-existing asthma requires close supervision during pregnancy. Animal studies do not indicate an increased risk to foetus. At the time of writing, there is limited information on the use of birch pollen allergen extract during pregnancy.


    Use birch pollen allergen extract with caution during breastfeeding.

    The manufacturer states that no effects on breastfed infants are expected. At the time of writing, limited clinical data are available for the use of birch pollen allergen extract during breastfeeding.


    Immediately after opening, take with dry fingers from the blister unit. Dissolve the medicine under the tongue.

    Avoid swallowing within 1 minute and food and drinks for the next 5 minutes.

    Advise patient to seek medical advice if asthma appears to be worsening.

    Advise patient to contact the doctor immediately in the event of a reaction.

    Side Effects

    Abdominal pain
    Anaphylactic reaction
    Chest discomfort
    Dry throat
    Ear pruritus
    Gastroesophageal reflux disease
    Laryngeal oedema
    Lip blister
    Lip pruritus
    Mouth ulcers
    Oedema of the lips
    Oral allergy syndrome
    Oral discomfort
    Oral hypoaesthesia
    Oral mucosal blistering
    Oral oedema
    Oral paraesthesia
    Oral pruritus
    Oropharyngeal oedema
    Oropharyngeal pain
    Pharyngeal paraesthesia
    Sensation of foreign body
    Throat irritation
    Throat tightness
    Tongue pruritus
    Tongue swelling


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2022

    Reference Sources

    Summary of Product Characteristics: ITULAZAX 12 SQ-Bet. ALK-Abello Ltd. Revised June 2021.

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