Odactra

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Odactra

Method of action: Immunological Agent

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Odactra

What is Odactra? Defining the Immunological Agent

Property Description
Active ingredient House Dust Mite Allergen Extract
Form Sublingual tablet (lyophilized)
Pharmacological class Allergen Immunotherapy (AIT)
Common use Disease modification in dust mite allergy
Origin Modified biological product (mite cultures)

Odactra is a prescription biological product whose active ingredient is House Dust Mite Allergen Extract, classified as an Allergenic Extract. It belongs to the therapeutic category of Allergen Immunotherapy (AIT), which is a specialized, long-term form of treatment designed to alter the core allergic disease process. Odactra is indicated for individuals aged 5 through 65, defining a distinct patient group for this therapy.

Unlike traditional medications intended for immediate symptom relief, such as antihistamines, AIT functions as a disease-modifying therapy. The general therapeutic purpose is to address the underlying cause of the allergy by gradually reprogramming the immune system's response to the specific allergen, fostering the long-term goal of immune tolerance.


Composition and Form: A Standardized Sublingual Tablet

The active component is derived from standardized extracts of the two primary house dust mite species, Dermatophagoides farinae and Dermatophagoides pteronyssinus, making it a modified natural extract. This extract contains specific allergen proteins, such as Der p 1 and Der f 1, which are crucial for the therapy’s intended effect.

Odactra is supplied as a lyophilized sublingual tablet for sublingual administration—that is, the tablet is placed under the tongue where it rapidly dissolves. The extract is standardized using a method known as SQ-HDM, which ensures consistent potency and allergen content between batches. This quality control measure is a functional requirement for immunotherapy and is a key feature of regulated AIT products.


Odactra’s Therapeutic Strategy: Tolerance, Not Symptom Relief

The central strategy of the therapy is the induction of tolerance through controlled, sustained exposure to the specific mite allergens. This process involves shifting the immune system's activity away from immediate, inflammatory reactions toward a less reactive state. This sustained desensitization process is key to the therapeutic goal.

This approach is focused on achieving a sustained desensitization to the mite proteins, which aims to reduce the severity of the body’s allergic responses to subsequent natural environmental exposure. This mechanism supports its role as a therapeutic tool aimed at reducing the underlying hypersensitivity over the long term, rather than providing temporary symptomatic relief.

Regulatory References

  1. NIH Review on Allergen Immunotherapy

What side effects are possible with Odactra?

Possible Side Effects and Safety Information

The safety profile for Odactra (House Dust Mite Allergen Extract), a sublingual allergen immunotherapy, is structured by regulatory documents based on the type and frequency of reported adverse reactions. The most frequently observed reactions are localized allergic responses at the administration site, consistent with the nature of the therapy. These effects are classified using standard frequency tiers established by regulatory authorities.


Frequency-Classified Adverse Reactions

The adverse reactions most commonly documented in official regulatory labeling involve the oral cavity and throat, falling primarily into the System-Organ Classes of Gastrointestinal Disorders and Respiratory, Thoracic and Mediastinal Disorders.

Classification Examples of Documented Reactions
Very Common (ge 1/10) Oral Pruritus (mouth itching), Throat Irritation
Common (ge 1/100 to < 1/10) Mouth Edema (swelling), Tongue Pruritus, Nasal Congestion
Uncommon (ge 1/1,000 to < 1/100) Dysphagia (difficulty swallowing), Laryngeal Edema

Serious Safety Considerations and Restrictions

Official labeling recognizes the potential for Anaphylaxis as a serious systemic allergic reaction. The frequency of adverse reactions, including local effects, is explicitly documented as being more frequent during the first week of treatment initiation.

Safety is formally established only within specific patient groups. Use is restricted by several documented contraindications, including patients with severe, unstable, or uncontrolled asthma. Additionally, regulatory agencies limit use to specific age ranges, such as 12 to 65 years in the U.S. and 5 to 65 years in the E.U., with safety and effectiveness not established outside these groups.

Overdose and Emergency Response

The official overdose profile for Odactra (House Dust Mite Allergen Extract) is primarily defined by the potential for life-threatening systemic allergic reactions, including anaphylaxis, which is documented in regulatory prescribing information.

The clinical manifestations that warrant urgent intervention include severe respiratory distress such as trouble breathing, throat tightness, or upper airway compromise. Other signs listed in official documentation include dizziness or fainting, rapid or weak heartbeat, and severe reactions affecting the skin or gut, such as flushing, hives, or severe stomach cramps and vomiting.

In the event of these severe symptoms, government regulatory documents mandate that the patient must stop taking ODACTRA immediately and seek immediate medical care. To manage this risk, auto-injectable epinephrine is officially required to be prescribed to all patients for use as emergency treatment.

The regulatory framework emphasizes vigilance, requiring the initial dose to be administered under medical supervision, with the patient observed for at least 30 minutes. Additionally, official labeling notes specific population constraints, indicating that patients with conditions like markedly compromised lung function or cardiovascular disease may have reduced capacity to survive a serious allergic reaction.

Therapeutic Uses of Odactra

What Odactra Treats: Main Uses and Benefits

The treatment is relevant in situations where patients experience discomfort associated with house dust mite allergy. The therapy is used in conditions presenting with systemic or localized discomfort associated with perennial allergic disease, where symptoms are caused by year-round exposure to Dermatophagoides farinae and Dermatophagoides pteronyssinus. The primary therapeutic domain is long-term disease modification, which may assist with maintaining functional stability.

The medication is used to help with managing symptom clusters related to inflammatory or irritative states, associated with allergic rhinitis and allergic conjunctivitis. This includes symptoms related to physical discomfort such as chronic sneezing, runny nose, nasal congestion, and recurring itchy or watery eyes. By contributing to easing the overall symptom load, the treatment may assist with maintaining a sense of stability when symptoms are more noticeable, supporting improved day-to-day comfort.


Quick Fact: Relief for Year-Round Symptoms Odactra is relevant for managing perennial (year-round) allergic symptoms, helping to control persistent discomfort caused by continuous exposure to house dust mites indoors.

Eligibility and Restrictions for Use

Eligibility for Odactra

Odactra is approved for use in individuals 5 through 65 years of age who have house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by specific allergy testing.


Who Must Not Take Odactra (Contraindications)

Odactra is contraindicated and must not be used in people who have:

  • Severe, unstable, or uncontrolled asthma.
  • A history of eosinophilic esophagitis.
  • A history of any severe systemic allergic reaction.
  • A history of any severe local reaction after taking any sublingual allergen immunotherapy (SLIT).
  • Known hypersensitivity (allergy) to any of the inactive ingredients.

Use Restrictions and Special Considerations

Treatment should be stopped to allow for complete healing if oral inflammation or wounds (e.g., mouth ulcers, cuts, or thrush) are present. The first dose must be taken under the supervision of a healthcare professional in a medical setting, with observation for at least 30 minutes, due to the risk of severe allergic reactions. The safety and effectiveness of Odactra are not established for patients younger than 5 or older than 65.

What should I know about interactions with other medicines?

Odactra Interactions with other medicines and products

The interaction profile for Odactra (House Dust Mite Allergen Extract) is based primarily on pharmacodynamic effects related to managing a severe allergic reaction, as this standardized biological product does not undergo typical small-molecule metabolism. Officially documented interactions focus on preserving the efficacy of emergency treatment.

Documented Interactions with Medicines

Interaction Type Examples of Interacting Agent Classes
Epinephrine Response Beta-blockers, MAOIs, TCAs, Cardiac Glycosides, Diuretics
Immunotherapy Risk Other concurrent Allergen Immunotherapy (AIT) products

Medications that can inhibit or potentiate the effects of epinephrine are officially noted because they may compromise a patient’s ability to survive a serious systemic allergic reaction. This list includes Beta-blockers and Tricyclic Antidepressants (TCAs), among others. Co-administration with other forms of AIT is not studied and carries a potential for increased systemic adverse reactions.

Procedural and Pharmacokinetic Considerations

Timing Constraints: The official labeling includes a procedural constraint for administration: the tablet must not be taken with food or beverages, and consumption must be avoided for at least 5 minutes after taking the dose.

Pharmacokinetics: The regulatory data does not document any clinically relevant pharmacokinetic interactions, such as those mediated by CYP enzymes or drug transporters, which is consistent with the nature of the active ingredient.

Mechanism of Action

How Odactra Works: Mechanism of Action

Odactra functions as an immunomodulator that specifically modifies the immune system's response to house dust mite (HDM) allergens. This process is initiated by the allergen component acting upon Antigen-Presenting Cells and T-lymphocytes in the oral mucosa.

The initial interaction promotes a fundamental shift in T-cell polarization, favoring the development of Regulatory T-cells and a T-helper 1 (Th1) response. This shift suppresses the production of Th2-related cytokines, which drives allergic inflammation. Downstream, this influences B-lymphocyte activity, resulting in an Immunoglobulin Class Switch—a reduction in allergic IgE antibodies and a corresponding increase in IgG4 blocking antibodies. These IgG4 antibodies circulate and bind directly to the HDM allergen, competing with IgE for binding sites.

The net physiological consequence of the altered T-cell activity and the presence of blocking antibodies is the desensitization of effector cells, such as Mast Cells and Basophils. This mechanism raises the physiological threshold required for effector cell degranulation upon subsequent natural allergen exposure.

Dosage and Administration Information

Odactra is a sublingual tablet that must be taken once daily according to the instructions provided by a healthcare professional. It is approved for use in individuals 5 through 65 years of age.

Administration Procedure

For proper use, follow these steps:

  1. Take the tablet from the blister unit after carefully removing the foil using dry hands.
  2. Place the tablet immediately under the tongue where it will dissolve within approximately 10 seconds.
  3. Do not swallow for at least one minute.
  4. Do not take food or beverages with the tablet, and avoid consuming any food or beverage for at least five minutes after taking the dose.
  5. Wash your hands after handling the tablet.

First Dose and Missed Doses

The first dose of Odactra must be administered in a healthcare setting under the supervision of a healthcare professional experienced in treating allergic diseases. The patient must be observed for at least 30 minutes following this initial dose.

If a dose is missed, do not take two tablets (do not double the dose). The patient should resume the normal dosing schedule by taking the next tablet at the next scheduled time the following day. If more than one dose is missed, the patient or caregiver should contact the healthcare provider before restarting therapy.

Recent Clinical Evidence

Research evidence / Overview of studies for Odactra


Evidence for Use in Allergic Rhinitis and Conjunctivitis

Odactra was studied for its use in individuals with year-round (perennial) allergy symptoms caused by house dust mites, specifically focusing on outcomes related to physical discomfort like allergic rhinitis and allergic conjunctivitis. The core research was evaluated in a series of large-scale clinical trials, primarily using a Randomized, Double-Blind, Placebo-Controlled design. The studies monitored patient-reported outcomes over an extended period, typically around one year (52 weeks) of daily administration. Researchers tracked a Total Combined Score (TCS), which measures the daily severity of symptoms and the daily use of rescue allergy medications. In these research scenarios, the findings describe patterns observed in the studies over the course of the treatment year.


Study Design and How Outcomes Were Measured

The research for Odactra was conducted using robust study methods, such as randomized, double-blind protocols. The participants in these studies were observed in settings with controlled study protocols. To measure the results of the research, scientists relied on patient-reported outcomes describing perceived discomfort. Using these methods, studies monitored changes in outcomes linked to inflammatory or irritative states. The research designs across different trials are considered consistent, contributing to the broader evidence landscape.


Long-Term Follow-up and Durability of Response

Most of the primary clinical research was evaluated in trials that lasted for approximately one year. This means the research provides context on short-term changes and patterns observed while the patient is actively receiving the study product. The follow-up durations were limited primarily to this one-year period for the main efficacy assessment. Research is ongoing and evidence is limited regarding the durability of the observations years after the one-year course is completed. Therefore, the degree to which the observations persist over many years after the study product was stopped remains an area where certainty remains low.


Evidence in Special Populations

Odactra was studied for use in a broad range of ages, including dedicated trials that enrolled children aged 5 through 11 years, as well as adolescents and adults up to age 65. The results apply only to the populations studied, meaning there is limited information for children younger than 5 years old and adults over the age of 65. In addition, some research explored the use of the therapy in participants who also had co-morbid mild to moderate allergic asthma. However, the primary focus and endpoints of these studies remained on the outcomes related to physical discomfort of allergic rhinitis and conjunctivitis.

Frequently Asked Questions (FAQ)

Common questions about Odactra (FAQ)

Q: Does Odactra interact with food or drink?

A: Yes, official administration guidelines include a constraint regarding food and beverages. Regulatory documents state that consuming food or drink during or immediately after placing the tablet under your tongue may reduce the amount of the allergen extract available for absorption. Therefore, it is recommended to avoid all food and drinks for at least five minutes after the dose, as outlined in the administration guidelines.

Q: Can I take Odactra with other allergy medicines like antihistamines or nasal sprays?

A: Official labeling notes that co-administration with medications that can inhibit or potentiate the effects of epinephrine, such as certain beta-blockers, is a documented concern. The product information also warns that co-administration with other types of Allergen Immunotherapy (AIT) may increase the likelihood of adverse reactions. Interactions with common, non-AIT allergy symptom relief medications like oral antihistamines or nasal sprays are not specifically addressed on the label.

Q: How long do I have to take Odactra to see results?

A: Odactra is a disease-modifying therapy, meaning it is designed to work over time by altering the immune system's response. Clinical studies designed to measure efficacy and symptom improvement monitored patient outcomes over an extended period, typically around one year (52 weeks) of daily administration.

Q: Can I drink coffee or alcohol while on Odactra?

A: Official product information advises against the use of alcohol with the allergen extract. This is because it may increase the risk and severity of allergic reactions that could occur while on therapy. Coffee is not specifically mentioned in the interaction warnings.

Q: Where exactly should I store Odactra in my home?

A: Odactra must be stored according to specific regulatory requirements to maintain its stability and effectiveness. Official guidance requires the product to be kept at controlled room temperature (20 C to 25 C), protected from moisture, and stored in its original package. It must also be kept out of the reach of children.

How should Odactra be stored and disposed of?

How to Store and Dispose of Odactra?

The storage and disposal of Odactra (House Dust Mite Allergen Extract) must adhere strictly to the conditions defined in the official prescribing information to maintain product stability and ensure safety.


Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature: 20 C to 25 C (68 F to 77 F).
Environment Must be kept in a dry place and protected from moisture.
Prohibited Keep from freezing and away from excessive heat.
Packaging Store in the original package (carton and blister pack) until immediately before use.
Child Safety Mandatory to keep out of the reach of children.

Stability and Disposal

Official labeling ties the product's 36-month shelf-life to maintaining the required storage temperature. Any unused or expired Odactra must be thrown away after the expiration date listed on the package. Consistent with regulatory guidelines for many prescription medicines, tablets should not be flushed down the toilet or poured into a drain.

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

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