Allergen extracts house dust mite oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral lyophilisate formulation of house dust mite standardised allergen extract.
Drugs List
Therapeutic Indications
Uses
Allergic asthma - house dust mite
Allergic rhinitis - house dust mite
Persistent moderate to severe house dust mite allergic rhinitis despite using medication to alleviate symptoms.
House dust mite allergic asthma associated with mild to severe house dust mite allergic rhinitis when symptoms not controlled well by inhaled corticosteroids.
Dosage
Adults
One oral lyophilisate (12 SQ-HDM) daily up to 18 months.
Children
Children aged 12 to 18 years
(See Dosage; Adult)
Additional Dosage Information
Contact a physician before resuming treatment if interruption occurs for more than 7 days.
Taking anti-allergic medications concomitantly with house dust mite allergen extract may increase patient's tolerance level to immunotherapy. Therefore, this needs to be taken into consideration when discontinuing anti-allergic medications.
Contraindications
Autoimmune disease
Children under 12 years
Immunosuppression
Acute respiratory infection in pre-existing asthma
Acute severe oral inflammation
FEV1 below 70% of predicted value at baseline
Malignant neoplasm
Oral wound
Severe asthma
Precautions and Warnings
Children aged 12 to 18 years
History of autoimmune disorder
Patients over 65 years
Asthma
Breastfeeding
Cardiac disorder
Pregnancy
Not suitable for acute treatment of asthma
Exclude gastrointestinal infection before commencing treatment
First dose should be given under medical supervision: Risk of anaphylaxis
Treatment to be initiated and supervised by a specialist
Have adrenaline injection ready for use in case of anaphylaxis
Monitor patient for 30 minutes after first administration
Advise patient to report gastrointestinal signs or symptoms
Advise patient to report if allergic reaction occurs
Advise patient to seek medical advice if asthma seems to be worsening
Consider antihistamines if severe local adverse reactions occur
Discontinue if no improvement after treatment for one year
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue permanently if hypertensive crisis occurs
Not licensed for all indications in all age groups
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
House dust mite allergen extracts should be used initially as add on therapy, not a substitution of pre-existing asthma medication. It is not recommended to discontinue asthma medication abruptly after starting the treatment.
Discontinue treatment and contact physician in case of severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty swallowing and breathing, voice changes, hypotension or throat feeling full. The onset of systemic symptoms include flushing, pruritus, sense of heat, general discomfort and agitation/anxiety.
Consider treatment carefully if patient previously experienced systemic allergic reaction to subcutaneous house dust mite immunotherapy due to increase risk of severe allergic reaction.
Postpone treatment and interrupt ongoing treatment if patient experiences severe oral inflammation such as oral lichen planus, mouth ulcers or thrush, oral wounds, oral surgery, or tooth loss to allow healing of the oral cavity.
Pregnancy and Lactation
Pregnancy
Use house dust mite allergen extracts with caution during pregnancy.
The manufacturer does not recommend initiating treatment during pregnancy and use with caution if pregnancy occurs during treatment. At the time of writing, there is limited published information regarding the use of house dust mite allergen extracts during pregnancy. Animal studies indicate no increased risk of teratogenic or developmental effects however potential risks are unknown. If house dust mite allergen extracts is used during pregnancy, evaluate lung function and reaction to previous use to consider continuation of treatment during pregnancy. Close supervision of pre-existing asthma in pregnant patients is recommended.
Lactation
Use house dust mite allergen extracts with caution during breastfeeding.
The manufacturer advises caution if house dust mite allergen extracts is used when breastfeeding. The presence of house dust mite allergen extracts in human breast milk is unknown. Effects on exposed infants are not anticipated.
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.
Side Effects
Abdominal pain
Allergic conjunctivitis
Allergic reaction
Anaphylactic reaction
Angioedema
Asthma
Bronchitis
Chest discomfort
Cough
Diarrhoea
Dizziness
Dry mouth
Dyspepsia
Dysphagia
Dysphonia
Dyspnoea
Ear discomfort
Ear pruritus
Erythema
Exacerbation of pre-existing asthma
Eye pruritus
Fatigue
Gastroesophageal reflux disease
Glossitis
Glossodynia
Hypertensive crisis
Laryngeal oedema
Laryngitis
Lip pain
Lip pruritus
Lip ulceration
Malaise
Mouth ulcers
Nasal congestion
Nasal discomfort
Nasal obstruction
Nasal oedema
Nasopharyngitis
Nausea
Oedema of the lips
Oesophagitis
Oral discomfort
Oral mucosal blistering
Oral mucosal erythema
Oral oedema
Oral pain
Oral paraesthesia
Oral pruritus
Oropharyngeal irritation
Oropharyngeal pain
Palpitations
Paraesthesia
Pharyngeal erythema
Pharyngeal oedema
Pharyngitis
Pruritus
Rhinitis
Rhinorrhoea
Salivary gland enlargement
Salivary hypersecretion
Sensation of foreign body
Sinusitis
Sneezing
Stomatitis
Taste disturbances
Throat irritation
Throat tightness
Tongue oedema
Tongue pruritus
Tonsillar hypertrophy
Tracheal oedema
Urticaria
Vomiting
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 ).
Reference Sources
Summary of Product Characteristics: Acarizax 12 SQ-HDM. ALK-Abello Ltd. Revised May 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 January 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.