ACARIZAX Oral lyophilisate Ref.[50644] Active ingredients:

Asthma

Asthma is a known risk factor for severe systemic allergic reactions.

Patients should be advised that 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.

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 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 ACARIZAX of patients with cardiac disease is limited.

This should be taken into consideration prior to initiating allergy immunotherapy.

Initiation of 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 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 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 esophagitis

Isolated cases of eosinophilic esophagitis have been reported in association with ACARIZAX treatment. In patients with severe or persisting gastro-esophageal symptoms such as dysphagia or dyspepsia, medical attention must be sought.

Autoimmune diseases in remission

Limited data is available on treatment with allergy immunotherapy in patients with autoimmune diseases in remission. ACARIZAX should therefore be prescribed with caution in these patients.

Food allergy

ACARIZAX may contain trace amounts of fish protein. Available data have not indicated an increased risk of allergic reactions in patients with fish allergy.

No interaction trials have been conducted in humans and no potential drug interactions have been identified from any source. Concomitant therapy with symptomatic anti-allergic medications may increase the tolerance level of the patient to immunotherapy. This should be considered at discontinuation of such medications.

Pregnancy

There is no data on the clinical experience for the use of ACARIZAX in pregnant women. Animal studies do not indicate increased risk to the foetus.

Treatment with ACARIZAX should not be initiated during pregnancy. If pregnancy occurs during treatment, the treatment may continue after evaluation of the general condition (including lung function) of the patient and reactions to previous administration of ACARIZAX. In patients with pre-existing asthma close supervision during pregnancy is recommended.

Breast-feeding

No clinical data are available for the use of ACARIZAX during lactation. No effects on the breastfed infants are anticipated.

Fertility

There is no clinical data with respect to fertility for the use of ACARIZAX. In a repeat dose toxicity study in mice no effects were observed in the reproductive organs of both genders.

Treatment with ACARIZAX has no or negligible influence on the ability to drive or use machines.

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 section 4.4). 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 section 4.4).

Isolated cases of severe acute worsening of asthma symptoms have been reported. Patients with known risk factors should not initiate treatment with ACARIZAX (see section 4.3).

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).

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 section 4.2). 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 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 section 4.4).

^* In clinical trials cough was observed with the same frequency for ACARIZAX and placebo.

Paediatric population

ACARIZAX is not indicated in children <12 years of age (see section 4.2). 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 authorisation 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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.