Adverse reactions : תופעות לוואי

4.8            Undesirable effects
Summary of the safety profile
Subjects taking ACARIZAX should primarily expect mild to moderate local allergic reactions to occur within the first few days and subsiding again with continued treatment (1-3 months) (see section 4.4). For the majority of events, the reaction should be expected to start within 5 minutes after intake of ACARIZAX on each day of occurrence and abate after minutes to hours. More severe oropharyngeal allergic reactions may occur (see section 4.4).
Isolated cases of severe acute worsening of asthma symptoms have been reported. Patients with known risk factors should not initiate treatment with ACARIZAX (see section 4.3).
Tabulated list of adverse reactions
The following table of adverse reactions is based on data from placebo-controlled clinical trials investigating ACARIZAX in adult and adolescent patients with house dust mite allergic rhinitis and/or allergic asthma and spontaneous reporting.
Adverse reactions are divided into groups according to the MedDRA convention frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
System Organ Class           Frequency               Adverse Drug Reaction 
Infections and infestations Very common              Nasopharyngitis
Common                   Bronchitis, pharyngitis, rhinitis, sinusitis Uncommon                Laryngitis
Immune system disorders      Uncommon                Anaphylactic reaction Nervous system disorders     Common                  Dysgeusia
Uncommon                Dizziness, paraesthesia
Eye Disorders                Common                  Eye pruritus
Uncommon                Conjunctivitis allergic
Ear and labyrinth            Very common             Ear pruritus disorders
Uncommon                Ear discomfort
Cardiac disorders            Uncommon                Palpitations
Respiratory, thoracic and    Very common             Throat irritation mediastinal disorders
Common                  Asthma, cough*, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema
Uncommon                Nasal congestion, nasal discomfort, nasal oedema, pharyngeal erythema, rhinorrhoea, sneezing, throat tightness, tonsillar hypertrophy
Rare                    Laryngeal oedema, nasal obstruction, tracheal oedema Gastrointestinal disorders   Very common             Lip oedema, oedema mouth, oral pruritus Common                  Abdominal pain, diarrhoea, dysphagia, dyspepsia, gastrooesophageal reflux disease, glossodynia, glossitis,
lip pruritus, mouth ulceration, oral pain, tongue pruritus,
nausea, oral discomfort, oral mucosal erythema,
paraesthesia oral, stomatitis, tongue oedema, vomiting
Uncommon                Dry mouth, lip pain, lip ulceration, oesophageal irritation, oral mucosal blistering, salivary gland enlargement,
salivary hypersecretion
Rare                    Eosinophilic oesophagitis
Skin and subcutaneous        Common                  Pruritus, urticaria tissue disorders
Uncommon                Erythema
Rare                    Angioedema
General disorders and        Common                  Chest discomfort, fatigue administration site
Uncommon                Malaise, sensation of foreign body conditions


Description of selected adverse reactions
If the patient experiences significant adverse reactions from the treatment, anti-allergic medication should be considered.
Cases of serious systemic allergic reactions, including anaphylaxis have been reported post marketing. The medical supervision at first sublingual lyophilisate intake is therefore an important precaution (see section 4.2). However, cases of serious systemic allergic reaction have occurred at doses subsequent to the initial dose.
In case of acute worsening in asthma symptoms or severe systemic allergic reactions, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat a physician should be contacted immediately. Hypertensive crisis has been reported following respiratory distress shortly after intake of ACARIZAX. In such cases treatment should be discontinued permanently or until otherwise advised by the physician.
*In clinical trials cough was observed with the same frequency for ACARIZAX and placebo.
Paediatric population
ACARIZAX is not indicated in children <12 years of age (see section 4.2). Only limited data from children 5-11 years of age are available and no data on treatment with ACARIZAX in children <5 years of age exist.
Reported adverse reactions in adolescents have been similar in frequency, type and severity as in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il