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House Dust Mite Allergen Extract

Medically reviewed by Drugs.com. Last updated on Sep 27, 2020.

Pronunciation

(house dust mite al er juhn EK strakt)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Sublingual, Sublingual:

Odactra: 12 SQ-HDM

Brand Names: U.S.

  • Odactra

Pharmacologic Category

  • Allergen-Specific Immunotherapy

Pharmacology

While the exact mechanism has not been fully elucidated, specific immunotherapy (SIT) may act by inducing a switch from T helper 2 cell response (Th2) to T helper 1 cell (Th1) response resulting in decreased interleukin-4 (IL-4) and interleukin-5 (IL-5) and increased interleukin-10 (IL-10), production of IgG-blocking antibodies that compete with IgE antibodies for allergen binding, proliferation of regulatory T lymphocytes and cytokines, and decreases in mast cells, eosinophils, and early- and late-phase allergic responses (Leith 2006).

Use: Labeled Indications

House dust mite-induced allergic rhinitis: Treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or D. pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts in adults ≤65 years.

Limitations of use: Not indicated for the immediate relief of allergic symptoms.

Contraindications

Hypersensitivity to any component of the formulation; severe, unstable, or uncontrolled asthma; history of any severe systemic allergic reaction; history of any severe local reaction after taking any sublingual allergen immunotherapy; history of eosinophilic esophagitis.

Canadian labeling: Additional contraindications (not in the US labeling): Coadministration with beta-blockers; active oral cavity inflammatory conditions (eg, oral lichen planus with ulcerations, severe oral candidiasis, dental extraction).

Dosing: Adult

House dust mite-induced allergic rhinitis: Sublingual: One tablet once daily. Note: Data regarding restarting treatment after missing a dose are limited; in clinical trials, treatment interruptions ≤7 days were allowed.

Administration

Administer the first dose in a healthcare setting due to the potential for allergic reactions; monitor patient for ≥30 minutes after first dose. If well tolerated, subsequent doses may be taken at home. With dry hands, remove sublingual tablet from blister immediately prior to administration. Place tablet under tongue until completely dissolved and then wait at least 1 minute before swallowing. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following administration. Auto-injectable epinephrine should be made available to patients.

Storage

Store at 20ºC and 25ºC (68ºF and 77ºF). Store in original package to protect from moisture.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Dermatologic: Pruritus of the ear (52%)

Gastrointestinal: Glossalgia (14%), nausea (14%), oral itching (61%), stomach pain (11%), swelling of lips (18%), swollen tongue (16%), tongue ulcer (12%)

Hypersensitivity: Mouth edema (20%, uvula/back of mouth)

Respiratory: Pharyngeal edema (14%; can be severe), throat irritation (67%)

1% to 10%:

Cardiovascular: Chest discomfort (1%)

Dermatologic: Urticaria (1%)

Gastrointestinal: Diarrhea (7%), dysgeusia (10%), dyspepsia (2% to 3%), dysphagia (1%), gastroesophageal reflux disease (2%), lip pruritus (1%), oral mucosal erythema (2%), oral mucosa ulcer (10%), oral paresthesia (9%), stomatitis (3%), tongue pruritus (5%), vomiting (3%)

Nervous system: Mouth pain (3%)

Ophthalmic: Eye pruritus (2%)

Respiratory: Dry throat (1%), oropharyngeal pain (1%), pharyngeal erythema (2%), sneezing (2%), upper respiratory tract infection (2%)

<1%: Gastrointestinal: Eosinophilic esophagitis

Frequency not defined:

Hypersensitivity: Anaphylaxis

Respiratory: Laryngeal edema (can be severe)

Postmarketing: Dermatologic: Erythema of skin

ALERT: U.S. Boxed Warning

Severe allergic reactions:

House dust mite allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.

Do not administer to patients with severe, unstable, or uncontrolled asthma.

Observe patients in the office for at least 30 minutes following the initial dose.

Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

House dust mite allergen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.

House dust mite allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Warnings/Precautions

Concerns related to adverse effects:

• Esophagitis: Eosinophilic esophagitis has been reported with sublingual tablet immunotherapy; discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms (eg, dysphagia, chest pain). Use is contraindicated in patients with a history of eosinophilic esophagitis.

• Hypersensitivity reactions: [US Boxed Warning]: Life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restrictions, may occur. Local reactions in the mouth or throat may occur; consider discontinuation in patients experiencing escalating and persistent adverse reactions in the mouth or throat. Increased risk of local or systemic adverse reactions may occur when given with concomitant allergen immunotherapy.

Disease-related concerns:

• Respiratory disease: [US Boxed Warning]: Do not administer to patients with severe, unstable, or uncontrolled asthma. Withhold treatment if patient is experiencing an acute asthma exacerbation. Re-evaluate patients with recurrent asthma exacerbations and consider discontinuation. Use is contraindicated in patients with unstable or uncontrolled asthma.

Other warnings/precautions:

• Administration: [US Boxed Warning]: Auto-injectable epinephrine should be prescribed to patients; instruct patients on appropriate use and to obtain immediate medical care upon its use.

• Appropriate patient selection: [US Boxed Warning]: Use may not be suitable for patients with conditions that may reduce their ability to survive a serious allergic reaction, including but not limited to markedly compromised lung function (chronic or acute) and cardiovascular conditions (eg, unstable angina, recent MI, significant arrhythmia, uncontrolled hypertension).

• Appropriate use: [US Boxed Warning]: Use may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators due to concomitant drug therapy. The effect of epinephrine may be potentiated or inhibited by the following medications: Beta blockers, alpha blockers, ergot alkaloids, tricyclic antidepressants, levothyroxine, monoamine oxidase inhibitors, antihistamines (ie, chlorpheniramine, diphenhydramine), cardiac glycosides, and diuretics.

• Experienced health care provider: Should be administered under the supervision of healthcare providers experienced in the diagnosis and treatment of allergic diseases.

• Monitoring: [US Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a healthcare setting.

• Oral inflammation/wounds: Discontinue therapy to allow for complete healing of the oral cavity due to oral inflammation (eg, oral lichen planus, mouth ulcers, or thrush) or oral wounds following oral surgery or dental extraction.

Monitoring Parameters

Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose.

Pregnancy Considerations

Information related to the use of house dust mite allergen extract in pregnant women is limited (Shaikh 2012). In general, allergy immunotherapy may continue in women tolerating treatment who become pregnant after therapy has started. However, initiating allergy immunotherapy during pregnancy is generally avoided (Larenas-Linnemann 2016; Oykhman 2015).

Patient Education

What is this drug used for?

• It is used to treat a house dust mite allergy.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Itching in ear, mouth, or tongue

• Throat pain

• Throat irritation

• Diarrhea

• Change in taste

• Abdominal pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Painful swallowing

• Trouble swallowing

• Trouble speaking

• Heartburn

• Chest pain

• Fast heartbeat

• Passing out

• Dizziness

• Flushing

• Shortness of breath

• Cough

• Severe nausea

• Vomiting

• Abdominal cramps

• Mouth irritation

• Mouth sores

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.