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 Precautions). 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 Precautions).
Isolated cases of severe acute worsening of asthma symptoms have been reported. Patients with known risk factors should not initiate treatment with ACARIZAX (see Contraindications).
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). (See Table 4.)
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Description of selected adverse reactions: If the patient experiences significant adverse reactions from the treatment, anti-allergic medication should be considered.
Cases of systemic allergic reactions, including anaphylactic reactions have been reported post marketing and are considered a class effect. The medical supervision at first oral lyophilisate intake is therefore an important precaution (see Dosage & Administration). In some cases, the serious systemic allergic reaction has 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. Isolated cases of eosinophilic esophagitis have been reported (see Precautions).
Paediatric population: ACARIZAX is not indicated in children <12 years of age (see Dosage & Administration). 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 of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Health Authorities.