Acarizax

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Acarizax

Quick Facts

Property Description
Active ingredient Standardized house dust mite (HDM) allergen extract
Form Sublingual tablet (lyophilisate)
Pharmacological class Allergen Immunotherapy (AIT)
Common use Long-term treatment of HDM allergy
Origin Modified natural extract (biological drug)

What Type of Medicine is Acarizax and Its Class?

Acarizax is a prescription-only medicine that is classified as a biological drug and belongs to the therapeutic group of Allergen Immunotherapy (AIT), often referred to as specific immunotherapy. Its primary role is disease-modifying, aiming for the long-term treatment of the underlying allergic condition, rather than providing only temporary relief from symptoms. This class of therapy involves gradually altering the patient's immune system response to a specific allergen. As part of a therapeutic strategy that targets the root cause of the allergy, this approach is clinically recognized for providing sustained benefit beyond the treatment period. Acarizax is specifically positioned for use in adults and adolescents with confirmed HDM allergy.

Acarizax Composition and Sublingual Form

The active ingredients in Acarizax are a standardized allergen extract sourced from two primary species of house dust mite: Dermatophagoides pteronyssinus and Dermatophagoides farinae. This precise, measured blend makes it a combination product that targets the major allergens responsible for house dust mite allergy. A distinctive feature is its dosage form: a sublingual tablet (a lyophilisate), a highly soluble tablet designed to be placed under the tongue for absorption, utilizing the sublingual route of administration. The sublingual form provides a non-injectable, standardized way to deliver the allergen for the purpose of desensitization, offering a convenient alternative to traditional subcutaneous injection methods.

General Purpose: Inducing Long-Term Tolerance

The main objective of Acarizax therapy is to achieve immunological tolerance and subsequent desensitization in individuals with confirmed HDM allergy. By continuously presenting a controlled dose of the house dust mite allergen extract to the immune system, the treatment gradually trains the body to reduce its hypersensitive reaction. This disease-modifying approach is supported by pharmacological studies demonstrating its ability to affect the underlying mechanisms of allergy, providing a means of achieving a lasting reduction in the severity of allergic symptoms. This is the foundational goal for long-term treatment of associated conditions like allergic rhinitis or allergic asthma.

Regulatory References

  1. MedlinePlus: Allergies

What side effects are possible with Acarizax?

Possible side effects and safety information

The official safety profile for Acarizax, a sublingual allergen immunotherapy, is structured around adverse reactions categorized by frequency and system-organ class, strictly based on regulatory documents.


Frequency-Classified Adverse Reactions

The majority of documented adverse reactions are local allergic effects consistent with the sublingual route of administration. These events are classified in official regulatory information as:

Classification Representative Adverse Reactions
Very Common Oral pruritus (itching), Mouth oedema (swelling), Lip oedema, Throat irritation, Ear pruritus.
Common Asthma symptoms, Diarrhoea, Abdominal pain, Dyspepsia, Dysphagia, Urticaria (hives), Pruritus, Headache.
Uncommon Anaphylactic reaction, Palpitations, Dizziness, Pharyngeal oedema.
Rare Laryngeal oedema, Eosinophilic oesophagitis.

Safety Considerations and Restrictions

The label officially notes that local allergic reactions are most common during the first few days or weeks of treatment and are generally expected to subside with continued exposure (typically within three months). The official safety documentation identifies Severe Systemic Allergic Reactions, including Anaphylaxis, and rare events like Eosinophilic Oesophagitis, as potential risks of the therapy.

Specific safety restrictions apply, particularly regarding co-existing conditions. Acarizax is officially contraindicated in patients with a history of a severe asthma exacerbation within the previous three months or a Forced Expiratory Volume in 1 second (FEV1) below 70% of the predicted value. Furthermore, treatment initiation is officially postponed during an acute respiratory tract infection. The label also specifies that treatment should be temporarily interrupted in the presence of severe oral inflammation or following oral surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Acarizax is officially documented as potentially causing an exaggerated immunological manifestation, resulting in an increase in allergic symptoms or localized reactions. Taking more than the prescribed dose may lead to a range of presentations, primarily involving local symptoms in the mouth and throat.


Severe Outcomes and Emergency Actions

The primary concern is the potential for life-threatening systemic reactions, including anaphylaxis. Regulatory documents list severe outcomes affecting the respiratory system (such as bronchospasm and laryngopharyngeal swelling) and the circulatory system (including hypotension and syncope). Overdose can also result in the worsening of existing asthma.

If severe symptoms are experienced—such as difficulty in swallowing or breathing, changes in voice, or low blood pressure—official guidance mandates that the user must immediately stop the treatment and contact a doctor or a hospital immediately.


Management Profile

The official management approach for overdose involves symptomatic and supportive treatment. While no specific antidote is explicitly documented in the regulatory labeling, management procedures address the systemic reactions. Hospital monitoring is required for any case presenting with severe symptoms. No population-specific differential overdose severity is explicitly noted in the official labeling.

Therapeutic Uses of Acarizax

Main Uses of Acarizax

Acarizax is a sublingual immunotherapy (SLIT) designed to treat persistent allergic rhinitis and allergic asthma caused specifically by house dust mites. It is used for individuals whose symptoms are not well-controlled by symptom-relieving medications, such as antihistamines or nasal corticosteroids.

The treatment works by exposing the immune system to small, controlled doses of house dust mite allergens. Over time, this process aims to increase the body's tolerance, addressing the underlying cause of the allergic reaction rather than just temporarily masking the symptoms.

Conditions Treated

  • House Dust Mite Allergic Rhinitis: This includes chronic symptoms such as sneezing, an itchy or runny nose, and nasal congestion. Acarizax is indicated when these symptoms are moderate to severe and persist despite the use of other allergy medications.
  • House Dust Mite Allergic Asthma: In cases where allergic rhinitis is present alongside house dust mite-induced asthma, this treatment may be used as an add-on therapy. It is intended for those whose asthma is stabilized but continues to be triggered by dust mite exposure.

Benefits and Clinical Goals

The primary objective of treatment with Acarizax is to improve the patient's quality of life by reducing the frequency and intensity of allergic episodes.

Reduction in Symptoms

By modifying the immune response, the treatment can lead to a significant decrease in the daily discomfort associated with dust mite allergies. This includes clearer nasal passages and a reduction in ocular symptoms like itchy or watery eyes.

Improved Disease Control

For patients with allergic asthma, the treatment aims to enhance overall asthma control. This may result in a decreased risk of exacerbations (asthma attacks) and a reduced reliance on inhaled corticosteroids over the long term.

Long-term Tolerance

Unlike symptomatic treatments that only work while they are being used, immunotherapy is designed to provide lasting effects. The goal is to train the immune system so that it no longer perceives house dust mites as a significant threat, potentially providing relief that continues after the course of treatment is completed.

Regulatory References

  1. Australian Therapeutic Goods Administration (TGA) Public Assessment Report

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Acarizax — Official Regulatory Information

Acarizax eligibility is strictly defined by regulatory authorities based on age, indication, and specific clinical status. The medicine requires a confirmed House Dust Mite (HDM) sensitization diagnosis (via IgE or skin prick testing) before use.

Population Status Regulatory Rule (Official Classification)
Allowed Adults (18–65) for allergic rhinitis and asthma. Adolescents (12–17) for allergic rhinitis. Children (5–11) for allergic rhinitis (regionally).
Contraindicated Unstable, severe asthma (FEV1 < 70% predicted). Severe asthma exacerbation in the last 3 months. Active autoimmune or malignant diseases. Acute severe oral inflammation/wounds. Patients taking beta-blockers.
Use Not Established Children under 5 years of age. Adults over 65 years of age. All patients under 18 years for the allergic asthma indication.

Important Eligibility Statuses:

  • Pregnancy: Treatment must not be initiated during pregnancy. If pregnancy occurs during therapy, continuation may be permitted following careful patient evaluation.
  • Acute Illness: Initiation is postponed if the patient has asthma and is experiencing an acute respiratory tract infection.
  • Oral Health: Treatment must be temporarily interrupted following any oral surgery, such as dental extraction, until the oral cavity has healed.

What should I know about interactions with other medicines?

The official regulatory profile for this standardized house dust mite allergen extract is structured primarily by pharmacodynamic considerations related to the management of potential systemic allergic reactions.

Interaction Status

Classification Interacting Substance/Class Official Constraint
Contraindicated Beta-blockers May reduce the efficacy of adrenaline (epinephrine), which is the required rescue treatment.
Potentiation Risk Tricyclic Antidepressants, MAOIs, COMT Inhibitors May potentiate the effects of adrenaline, potentially leading to fatal consequences.
No Documented PK CYP Enzymes, Transporters, Food, Alcohol No formal human drug interaction trials have been conducted or identified.

Regulatory documents explicitly state that no drug interaction trials have been conducted in humans, and no potential drug interactions involving traditional pharmacokinetic mechanisms (metabolism or transport) have been identified from any source. This reflects the product's nature as an allergen extract.

The critical interaction-related restriction is the contraindication with beta-blockers, as these medicines can inhibit the therapeutic effects of adrenaline used for severe allergic reactions. Furthermore, substances such as tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOIs), and Catechol-O-methyl transferase (COMT) inhibitors may officially potentiate the effects of adrenaline, which is associated with a risk of severe cardiovascular events. Concomitant therapy with anti-allergic medications may officially increase the patient's tolerance level to the immunotherapy.

Mechanism of Action

The mechanism involves initiating an immunological shift in the T-cell population by controlled exposure to the house dust mite (HDM) allergen extract at the sublingual mucosa. This promotes the differentiation of specialized Regulatory T-cells (Treg cells). These Treg cells actively suppress the Type 2 Inflammatory Pathway through the release of inhibitory cytokines, such as Interleukin-10 and Transforming Growth Factor-beta, resulting in the long-term modulation of the hypersensitivity response.

This mechanism facilitates a molecular change in immunoglobulin production by influencing B-lymphocytes. The process reduces the synthesis of pathological Immunoglobulin E (IgE) antibodies while promoting the creation of high levels of Immunoglobulin G4 (IgG4). The accumulated IgG4 intercepts HDM allergens, preventing their binding to existing IgE fixed on Mast Cells and Basophils. By physically blocking this initial binding, the treatment inhibits the degranulation of these effector cells, leading to a modified physiological response in mucosal tissue.

Dosage and Administration Information

How to Use Acarizax: Official Administration Guidelines

Administration of Acarizax is based on a fixed-dose, sublingual, continuous maintenance regimen.


Dosing and Route

Acarizax is administered via the sublingual route (under the tongue) using a lyophilisate (freeze-dried tablet). The standard daily dose is a single 12 SQ-HDM sublingual lyophilisate, with no dose-escalation phase required before initiating treatment. This dose is used continuously for the recommended treatment duration, typically spanning three years.


Procedural Instructions

The medicine is designed for self-administration, but the first dose must be taken under medical supervision in a healthcare setting.

For daily use, the sublingual tablet must be placed immediately under the tongue after being removed from the blister with dry hands. It is essential to avoid swallowing for approximately one minute to ensure proper absorption. Furthermore, to maintain the effectiveness of the sublingual administration, consuming any food or drink must be avoided for at least 5 minutes after taking the medicine. The tablet must not be chewed or crushed.


Scheduling and Adjustments

Acarizax is taken once daily. If a dose is missed, it should be taken later that day, but a double dose must not be taken the following day. If the continuous daily administration is interrupted for more than seven days, patients should consult a physician before resuming the treatment. The 12 SQ-HDM dose is the same for adults and adolescents 12 years and older.

Recent Clinical Evidence

Research evidence / Overview of studies for Acarizax


Evidence for Use in Persistent HDM Allergic Rhinitis

Research involving Acarizax for persistent House Dust Mite (HDM) allergic rhinitis has included several large, international Randomized Controlled Trials (RCTs), which are considered the highest standard of clinical evidence. These trials are designed to evaluate the differences observed between the treatment group and a placebo group. These findings are supported by subsequent analyses, including Systematic Reviews and Meta-analyses. Furthermore, Real-World Observational Studies have been used to track the medicine's use in daily-life settings.

In these studies, the research examined patient-reported outcomes related to physical discomfort and functional imbalance that characterizes allergic rhinitis. Researchers monitored changes in specific scores that combine measurements of symptoms (such as sneezing, nasal congestion, and itchy eyes) with the use of symptomatic relief medications. Findings were reported based on comparisons made between the treatment group and the placebo group. Outcomes reflecting daily functioning or activity level, such as Quality-of-Life questionnaires, were also studied. Historical meta-analyses of HDM sublingual immunotherapy research have noted heterogeneity in the design, specific dose, and outcome measures across the broader scientific literature.


Evidence for Use in Associated HDM Allergic Asthma

Research involving Acarizax was evaluated for the indication of HDM Allergic Asthma when it occurs alongside allergic rhinitis. These studies were designed to examine the medicine in a specific population of Adults (18–65 years) whose asthma was not well controlled by standard inhaled corticosteroids. The primary evidence base consists of pivotal, placebo-controlled Phase III trials.

The main focus of these trials was to monitor episodic or acute changes by tracking the time to the first occurrence of a moderate or severe asthma exacerbation (a flare-up). Other research examined temporary physiological imbalance by monitoring changes in the required dose of inhaled corticosteroid (ICS) medication during defined reduction or withdrawal periods. Studies reported data related to these acute episodic changes. Evidence contributes to understanding symptom patterns in patients with conditions involving periods of heightened symptoms.

Generalizability of some asthma trial findings may be limited. The study design included a period where patients reduced or withdrew their inhaled corticosteroids; this methodology has been noted in regulatory assessments as potentially impacting how widely the exacerbation rate data can be applied to all clinical settings.


Long-Term Clinical Studies and Follow-up Duration

The core efficacy period for primary outcomes in the randomized controlled studies was typically assessed after approximately one year of treatment. However, continuous use has been observed in trials and post-marketing surveys, documenting responses over defined time intervals lasting up to three to four years.

What remains largely uncertain are the outcomes that extend many years beyond the treatment period itself. Long-term effects are not fully established, and there is limited information available concerning the durability of any observed changes after the full course of treatment has ended.

Key Studies & References

  1. Sublingual immunotherapy for allergic rhinitis: a systematic review and meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Acarizax (FAQ)


Q: How quickly can I expect to see any changes from taking Acarizax?

Studies and official product information indicate that initial symptom improvements may begin to be observed after approximately 8 to 14 weeks of consistent daily treatment. However, the comprehensive efficacy of the treatment is typically assessed after one full year of use, as the medicine works gradually to modify the immune response.


Q: Do I need to take Acarizax forever?

No. Official documents state that the standard recommended treatment duration is typically three years. If a patient does not show improvement after the first year of therapy, official guidance indicates that continuation is not indicated.


Q: What is the duration of the recommended treatment course for Acarizax?

The recommended duration for continuous daily treatment with Acarizax is typically three years.


Q: Is it safe to get vaccinated while taking Acarizax?

Regulatory guidance suggests that a consultation with a healthcare professional is recommended if a vaccination is planned. Regulatory documents recommend consulting with a healthcare professional before receiving a vaccination.


Q: Can Acarizax interact with herbal supplements?

Formal human drug interaction studies have not been conducted for this allergen extract. For safety, regulatory documents generally suggest that patients inform their healthcare professional about all other medicines, including supplements and herbal remedies, that they are taking.


Q: Can Acarizax be taken with blood pressure medication?

Official information lists beta-blockers as a contraindication because they can reduce the effectiveness of adrenaline (epinephrine), which is essential for treating a severe allergic reaction. No specific warnings are listed against taking Acarizax with other classes of blood pressure medications.


Q: Can Acarizax interact with medications for depression or anxiety?

Regulatory documents list special warnings for medicines such as tricyclic antidepressants and Monoamine Oxidase Inhibitors (MAOIs). These medicines may potentially increase the effects of adrenaline, which is used to treat severe allergic reactions, requiring caution.


Q: Is Acarizax a cure for my dust mite allergy?

Acarizax is classified as a disease-modifying Allergen Immunotherapy (AIT). Its function is to gradually increase the body’s immunological tolerance to the allergen, aiming for a lasting reduction in allergy symptoms. It is not described as a 'cure' in official product information.


Q: Is Acarizax the same as an allergy shot?

Acarizax is a type of Allergen Immunotherapy, but unlike traditional allergy shots (subcutaneous injections), it is a sublingual lyophilisate—a tablet that dissolves under the tongue. This provides a non-injectable, standardized way to administer the allergen extract.


Q: Can Acarizax be used to treat allergies other than dust mites?

No. The medicine contains a standardized allergen extract exclusively sourced from two primary species of house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae). It is officially indicated only for the treatment of house dust mite allergy.


Q: What is the difference between Acarizax and other allergy medications like antihistamines?

Acarizax is an Allergen Immunotherapy designed to be disease-modifying, meaning it works over a long period to alter the underlying immune system response and induce tolerance. Medications like antihistamines, conversely, are used primarily for temporary relief from allergy symptoms.


Q: Does Acarizax cause weight gain?

Weight gain is not listed as a very common, common, uncommon, or rare side effect in official regulatory documents.


Q: Is Acarizax safe for children to use?

Official product information states that the medicine is indicated for adolescents (12–17 years) for allergic rhinitis. It is not intended for use in children below 5 years of age. Additionally, it is not indicated for allergic asthma in patients under 18 years of age.


Q: Are there any long-term effects of using Acarizax?

Clinical trials have monitored continuous use for up to three or four years. Official documents indicate that long-term safety effects extending many years beyond the treatment period are not fully established, and information on the durability of the beneficial effects after the course ends is limited.


Q: Can women who are planning to become pregnant use Acarizax?

Official information states that treatment must not be started during pregnancy. If pregnancy occurs during therapy, continuation may be permitted following careful patient evaluation by a physician.


Q: Is it okay to stop taking Acarizax once my allergy symptoms improve?

If the medicine is not taken as prescribed for the full recommended duration, the patient may not achieve the long-term beneficial effects intended by the treatment. The recommended duration is typically three years of continuous use.


Q: Does Acarizax affect my ability to drive or operate machinery?

Official regulatory documents specifically state that Acarizax has no or negligible influence on the ability to drive vehicles or operate machinery.


Q: Can Acarizax be used for all types of dust mite allergies?

The medicine contains a standardized allergen extract from two specific species of house dust mites, Dermatophagoides pteronyssinus and Dermatophagoides farinae. It is used to treat allergy caused by confirmed sensitization to these specific mites.


Q: Does Acarizax work for year-round allergy symptoms?

Yes. Acarizax is indicated for the treatment of persistent moderate to severe house dust mite allergic rhinitis, which refers to allergy symptoms that occur throughout the entire year.


Q: What should I do if I miss multiple doses of Acarizax?

If a single daily dose is missed, regulatory guidance is to take it later that day. A double dose must not be taken the next day. If the continuous daily treatment is interrupted for more than seven days, official documents recommend consulting a healthcare professional before resuming therapy.


Q: Is Acarizax approved in different countries?

Acarizax has been authorized by multiple major governmental regulatory agencies around the world, which include the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Australia’s Therapeutic Goods Administration (TGA).


Q: Does Acarizax have a known withdrawal effect if treatment is stopped?

Official product information states that if the medicine is not taken as prescribed, the patient may not receive the beneficial effects of the treatment. There are no specific 'withdrawal' effects listed in the regulatory documents.


Q: Why is Acarizax taken once a day?

The daily administration schedule is a fixed-dose regimen based on the required pharmacodynamic effect. This single daily dose is sufficient to initiate and maintain the desired long-term immunological tolerance by the body.


Q: Is there a maximum time I can safely use Acarizax?

The standard recommended treatment course is typically three years, and studies have observed continuous use for up to four years. Official regulatory documents do not define a specific maximum safe duration beyond the periods that have been studied.


Q: What level of evidence supports the use of Acarizax?

The use of Acarizax is supported by evidence from large, international Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews, which are considered a high standard of clinical evidence by regulatory bodies.


Q: What are the requirements for starting Acarizax treatment?

Official requirements for initiating treatment include a confirmed diagnosis of House Dust Mite (HDM) sensitization, usually through a skin prick test or specific IgE blood test. Additionally, the patient must fall within the approved age and indication range and must not have any listed contraindications, such as severe, unstable asthma.


Q: Is it described in official sources that Acarizax is safe during breastfeeding?

Official product information states there is no clinical experience of using Acarizax during breastfeeding. However, it is stated that no effects on the breast-fed infant are anticipated. Patients are advised to consult their healthcare professional about continuing treatment while breastfeeding.


Q: Does Acarizax contain lactose or gluten?

Official product information on the excipients states that Acarizax does not contain lactose or gluten. Other excipients, such as fish gelatine, mannitol, and sodium hydroxide, are used.


Q: Why is this type of treatment often given for a long period?

The long-term nature of this therapy is required to achieve the fundamental shift in the immune system known as immunological tolerance. This process needs continuous, controlled exposure to the allergen over an extended period to ensure the therapeutic benefits are sustained.


Q: Are there specific storage requirements for Acarizax?

The medicine does not require special storage conditions concerning temperature. It must be kept in its original blister and carton until the time of use to protect the sensitive sublingual lyophilisate from the environment and moisture.

How should Acarizax be stored and disposed of?

Official Storage and Disposal Requirements

This section outlines the labeled conditions for storing and disposing of Acarizax, based strictly on regulatory documentation.

Storage Conditions

Acarizax does not require any special storage conditions regarding temperature. The product must be protected from the environment by being kept in its original carton and blister until the time of use. Because the sublingual lyophilisate is sensitive to moisture, it must be handled with dry hands and used immediately after the individual blister unit is opened.

For safety, the medicine must be stored out of the sight and reach of children.

Disposal Instructions

To ensure environmentally responsible disposal, Acarizax must not be disposed of via wastewater or household waste. Expired or unused medicine should be taken to a pharmacist for proper, sanctioned disposal. Do not use Acarizax after the expiry date stated on the carton.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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