Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: ALK-Abelló A/S, Bøge Alle 6-8, DK-2970 Hørsholm, Denmark
ACARIZAX is indicated in adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions:
ACARIZAX is indicated in adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
The recommended dose for adults and adolescents (12-17 years) is one oral lyophilisate (12 SQ-HDM) daily.
Onset of the clinical effect is to be expected 8-14 weeks after initiation.
International treatment guidelines refer to a treatment period of 3 years for allergy immunotherapy to achieve disease modification. Efficacy data is available for 18 months of treatment with ACARIZAX in adults; no data is available for 3 years of treatment (see section 5.1).
If no improvement is observed during the first year of treatment with ACARIZAX there is no indication for continuing treatment.
Allergic rhinitis: The posology is the same for adults and adolescents (12-17 years). The safety and efficacy of ACARIZAX in children <12 years of age have not been established. No data are available.
Allergic asthma: The efficacy of ACARIZAX in children <18 years of age has not been established. No data are available.
There is no clinical experience on immunotherapy with ACARIZAX in adults >65 years of age.
ACARIZAX treatment should be initiated by physicians with experience in treatment of allergic diseases.
The first oral lyophilisate should be taken under medical supervision and the patient should be monitored for at least half an hour, to enable discussion and possible treatment of any immediate side effects.
ACARIZAX is an oral lyophilisate. The oral lyophilisate should be taken with dry fingers from the blister unit immediately after opening the blister and placed under the tongue, where it will disperse. Swallowing should be avoided for approximately 1 minute. Food and beverage should not be taken for the following 5 minutes.
If treatment with ACARIZAX is interrupted for a period up to 7 days, treatment can be resumed by the patient. If the treatment is interrupted for more than 7 days it is recommended to contact a physician before resuming the treatment.
In phase I studies adult patients with house dust mite allergy were exposed to doses up to 32 SQ-HDM. No data are available in adolescents regarding exposure to doses above the recommended daily dose of 12 SQ-HDM.
If doses higher than the recommended daily dose are taken, the risk of side effects increases, including the risk of systemic allergic reactions or severe local allergic reactions. In case of severe reactions such as angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, or feeling of fullness in the throat, immediate medical evaluation is needed. These reactions should be treated with relevant symptomatic medication.
4 years.
This medicinal product does not require any special storage conditions.
Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates.
Pack sizes: 30 and 90.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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