Acarizax Special Precautions

Asthma: Asthma is a known risk factor for severe systemic allergic reactions.
Patients should be advised that Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is not intended to treat acute asthma exacerbations. In the event of an acute asthma exacerbation, a short-acting bronchodilator should be used. If patients find short-acting bronchodilator treatment ineffective or they need more inhalations than usual, medical attention must be sought.
Patients must be informed of the need to seek medical attention immediately if their asthma deteriorates suddenly.
Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) should initially be used as add on therapy and not as a substitute of pre-existing asthma medication. Abrupt discontinuation of asthma controller medication after initiation of Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) treatment is not recommended. Reductions in asthma controller medication should be performed gradually under the supervision of a physician according to asthma management guidelines.
Severe systemic allergic reactions: Treatment should be discontinued and a physician should be contacted immediately in case of severe systemic allergic reactions, severe asthma exacerbation, angioedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat. The onset of systemic symptoms may include flushing, pruritus, sense of heat, general discomfort and agitation/anxiety.
One option for treating severe systemic allergic reactions is adrenaline. The effects of adrenaline may be potentiated in patients treated with tricyclic antidepressants, mono amino oxidase inhibitors (MAOIs) and/or COMT inhibitors with possible fatal consequences. The effects of adrenaline may be reduced in patients treated with beta-blockers.
Patients with cardiac disease may be at increased risk in case of systemic allergic reactions. Clinical experience in treatment with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) of patients with cardiac disease is limited.
This should be taken into consideration prior to initiating allergy immunotherapy.
Initiation of Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) in patients who have previously had a systemic allergic reaction to subcutaneous house dust mite immunotherapy should be carefully considered, and measures to treat potential reactions should be available. This is based on post-marketing experience from a corresponding sublingual tablet product for grass pollen immunotherapy which indicates that the risk of a severe allergic reaction may be increased for patients who have previously experienced a systemic allergic reaction to subcutaneous grass pollen immunotherapy.
Oral inflammation: In patients with severe oral inflammation (e.g. oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery, including dental extraction, or following tooth loss, initiation of Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) treatment should be postponed and ongoing treatment should be temporarily interrupted to allow healing of the oral cavity.
Local Allergic Reactions: When treated with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) the patient is exposed to the allergen that causes the allergic symptoms. Therefore, local allergic reactions are to be expected during the treatment period. These reactions are usually mild or moderate; however, more severe oropharyngeal reactions may occur. If the patient experiences significant local adverse reactions from the treatment, anti-allergic medication (e.g. antihistamines) should be considered.
Eosinophilic oesophagitis: Cases of eosinophilic oesophagitis have been reported in association with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) treatment. In patients with severe or persisting gastro-oesophageal symptoms such as dysphagia or dyspepsia, Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) should be interrupted and medical evaluation must be sought.
Autoimmune diseases in remission: Limited data is available on treatment with allergy immunotherapy in patients with autoimmune diseases in remission. Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) should therefore be prescribed with caution in these patients.
Food allergy: Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) may contain trace amounts of fish protein. Available data have not indicated an increased risk of allergic reactions in patients with fish allergy.
Effects on ability to drive and use machines: Treatment with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) has no or negligible influence on the ability to drive or use machines.