ACARIZAX Der Pte Extract (Dermatophagoides Pteronyssinus) / Der Far Extract (Dermatophagoides Farinae) 6 SQ-HDM per active substance Tablet 30's

Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is indicated in adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitization (skin prick test and/or specific IgE) with at least one of the following conditions: persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication; house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment (see Contraindications).
Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is indicated in adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitization (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication.

 

Posology: 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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) in adults; no data is available for 3 years of treatment (see Pharmacology: Pharmacodynamics under Actions). If no improvement is observed during the first year of treatment with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) there is no indication for continuing treatment.
Pediatric population: Allergic rhinitis: The posology is the same for adults and adolescents (12-17 years). Clinical experience in treatment of allergic rhinitis with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) in children <12 years of age has not been established. Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is not intended for treatment of allergic rhinitis in children <12 years of age. Currently available data are described in Pharmacology: Pharmacodynamics under Actions.
Allergic asthma: Clinical experience in treatment of allergic asthma with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) in children <18 years of age has not been established. Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is not intended for treatment of allergic asthma in children <18 years of age.
Elderly population: Clinical experience on immunotherapy with Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) in adults >65 years of age has not been established. Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) is not intended for use in adults >65 years of age (see Pharmacology: Pharmacodynamics under Actions).
Method of administration: Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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.
Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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.

 

Overdosage

Should be taken on an empty stomach: Take 5 min before meals & beverage. Take w/ dry fingers from the blister unit immediately after opening the blister & place under the tongue, where it will disperse. Avoid swallowing for approx 1 min.

Hypersensitivity to any of the excipients.
Patients with FEV₁ < 70% of predicted value (after adequate pharmacological treatment) at initiation of treatment.
Patients who have experienced a severe asthma exacerbation within the last 3 months.
In patients with asthma and experiencing an acute respiratory tract infection, initiation of Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) treatment should be postponed until the infection has resolved.
Patients with active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance.
Patients with acute severe oral inflammation or oral wounds (see 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.

 

Use In Pregnancy & Lactation

Summary of the safety profile: Subjects taking Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) (see Contraindications).
Tabulated list of adverse reactions: The following table of adverse reactions is based on data from placebo-controlled clinical trials investigating Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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.)

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 oral lyophilisate intake is therefore an important precaution (see Dosage & Administration). 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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (Acarizax) and placebo.
Pediatric population: Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract (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 authorization 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 via the national reporting system.

 

Caution For Usage

Storage

Action

Antihistamines & Antiallergics