Acarizax

Acarizax

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dermatophagoides pteronyssinus extr, Dermatophagoides farinae extr
Indications/Uses
Adult patients 18-65 yr diagnosed by clinical history & a positive test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication; &/or house dust mite allergic asthma not well controlled by inhaled corticosteroids & associated w/ mild to severe house dust mite allergic rhinitis. Adolescents 12-17 yr diagnosed by clinical history & positive test of house dust mite sensitisation (skin prick test &/or specific IgE) w/ persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.
Dosage/Direction for Use
Adult & adolescent 12-17 yr 1 oral lyophilisate (12 SQ-HDM) daily.
Administration
Should be taken on an empty stomach: Tab should be removed from blisters w/dry fingers. Place tab under the tongue & let it disperse. Avoid swallowing in the following 1 min. Do not consume food & drink for 5 min after taking.
Contraindications
Hypersensitivity. Patients w/ FEV1 <70% of predicted value at initiation of treatment; severe asthma exacerbation w/in the last 3 mth; active or poorly controlled autoimmune disease, immune defects, immunodeficiencies, immunosuppression, or malignant neoplastic diseases w/ current disease relevance; acute severe oral inflammation or oral wounds. Postpone treatment in patients w/ asthma & experiencing acute resp tract infection until infection has resolved.
Special Precautions
Not intended for acute asthma exacerbations. Should initially be used as add-on therapy & not as a substitute of pre-existing asthma medication. Discontinue treatment 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. Patients w/ cardiac disease; previous systemic allergic reaction to SC house dust mite immunotherapy; autoimmune diseases in remission; & fish allergy. Postpone initiation of treatment & interrupt ongoing treatment w/ Acarizax in patients w/ severe oral inflammation (eg, oral lichen planus, mouth ulcers or thrush), oral wounds or following oral surgery including dental extraction, or following tooth loss. Risk of local allergic reactions; eosinophilic esophagitis. Pregnancy. Not intended for treatment of allergic rhinitis in childn <12 yr. Not intended for treatment of allergic asthma in childn <18 yr. Not intended for use in elderly >65 yr.
Adverse Reactions
Nasopharyngitis; ear pruritus; throat irritation; lip & mouth oedema, oral pruritus. Bronchitis, pharyngitis, rhinitis, sinusitis; dysgeusia; eye pruritus; asthma, dysphonia, dyspnoea, oropharyngeal pain, pharyngeal oedema; abdominal pain, diarrhoea, dysphagia, dyspepsia, GERD, glossodynia, glossitis, lip pruritus, mouth ulceration, tongue pruritus, nausea, oral discomfort, oral mucosal erythema, oral paraesthesia, stomatitis, tongue oedema, vomiting; pruritus, urticaria; chest discomfort, fatigue. Systemic allergic reactions, including anaphylactic reactions; hypertensive crisis; eosinophilic esophagitis.
Drug Interactions
Increased tolerance level of patient to immunotherapy w/ concomitant symptomatic anti-allergic medications.
ATC Classification
V01AA03 - house dust mites ; Belongs to the class of allergen extracts. Used as antigenic substances capable of producing immediate-type hypersensitivity.
Presentation/Packing
Form
Acarizax oral lyophilisate 12 SQ-HDM
Packing/Price
30's
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