Drugs List

Therapeutic Indications

Uses

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).

Contraindications

Autoimmune disease
Children under 18 years
Immunosuppression
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
Asthma
Breastfeeding
Cardiac disorder
Pregnancy

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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal pain
Anaphylactic reaction
Angioedema
Chest discomfort
Cough
Diarrhoea
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Ear pruritus
Gastroesophageal reflux disease
Glossitis
Glossodynia
Laryngeal oedema
Lip blister
Lip pruritus
Mouth ulcers
Nausea
Oedema of the lips
Oesophagitis
Oral allergy syndrome
Oral discomfort
Oral hypoaesthesia
Oral mucosal blistering
Oral oedema
Oral paraesthesia
Oral pruritus
Oropharyngeal oedema
Oropharyngeal pain
Pharyngeal paraesthesia
Rhinitis
Sensation of foreign body
Stomatitis
Throat irritation
Throat tightness
Tongue pruritus
Tongue swelling
Urticaria

Presentation

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

Drugs List

Therapeutic Indications

Uses

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).

Dosage

Adults

Additional Dosage Information

Contraindications

Autoimmune disease
Children under 18 years
Immunosuppression
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
Asthma
Breastfeeding
Cardiac disorder
Pregnancy

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

Pregnancy

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.

Lactation

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.

Counselling

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
Angioedema
Chest discomfort
Cough
Diarrhoea
Dry throat
Dysgeusia
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Ear pruritus
Gastroesophageal reflux disease
Glossitis
Glossodynia
Laryngeal oedema
Lip blister
Lip pruritus
Mouth ulcers
Nausea
Oedema of the lips
Oesophagitis
Oral allergy syndrome
Oral discomfort
Oral hypoaesthesia
Oral mucosal blistering
Oral oedema
Oral paraesthesia
Oral pruritus
Oropharyngeal oedema
Oropharyngeal pain
Pharyngeal paraesthesia
Rhinitis
Sensation of foreign body
Stomatitis
Throat irritation
Throat tightness
Tongue pruritus
Tongue swelling
Urticaria

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2022

Reference Sources

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