Identification

Summary

Dermatophagoides pteronyssinus is an extract from Dermatophagoides pteronyssinus used in allergy testing.

Brand Names
Acarizax, Odactra
Generic Name
Dermatophagoides pteronyssinus
DrugBank Accession Number
DB10401
Background

Dermatophagoides pteronyssinus extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. This combination is approved for as a year-round, once-a-day tablet that's dissolved under the tongue as a treatment for dust mite allergies.

Type
Biotech
Groups
Approved
Biologic Classification
Allergenics
Allergen Extract
Synonyms
  • AE-mite, dermatophagoides pteronyssinus
  • Dermatophagoides pteronyssinus whole
  • European house dust mite
  • European house dust mite extract
  • House dust mite extract, dermatophagoides pteronyssinus
  • Insects (whole body), mite dermatophagoides pteronyssinus
  • Mite D.P.
  • Mite D.P. (dermatophagoides pteronyssinus) standardized

Pharmacology

Indication

Dermatophagoides pteronyssinus is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. It is approved for use in adults 18 through 65 years of age.3

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Treatment with ACTAIR has been shown to induce a systemic antibody response towards house dust mite allergens, with an increase in specific IgG4 antibodies in some patients. These immunoglobulins may compete with IgE for allergen binding, thereby decreasing allergen capture and presentation.

Mechanism of action

The complete mechanisms of allergen immunotherapy are not clear and remain the subject of investigation. The allergic reaction is dependent on the presence of allergen-specific immunoglobulin E (IgE) antibodies that are bound to specific receptors on mast cells and basophils. The presence of IgE antibodies sensitizes these cells, and upon interaction with the appropriate allergens, histamine and other mediators are released which produce local or systemic responses in sensitive individuals, and characteristic symptoms of atopic diseases, such as allergic rhinitis and allergic asthma. Changes in serum antibody and T-lymphocyte responses resulting from immunotherapy have been demonstrated, and these changes often correlate closely with clinical (symptom) improvements. Specific mechanisms may vary depending on the nature of the allergic disease, the allergenic specificities of patients and populations, extract formulations, route of administration, dose and duration of treatment. Subcutaneous administration of allergenic extracts is known to elicit numerous immunological changes that are both time and dose-dependent. Many of these changes appear to be related to (or a precursor to) improvements in symptoms and other clinical parameters, as noted above. Specific changes found after immunotherapy with dust mite extracts include significant increases in mite-specific IgG4 antibodies, interleukin-10-positive T cells, and several T-cell receptors, and significant decreases in serum nitric oxide, eosinophil catonic protein, interleukin-4-positive T cells and IgE-mediated basophil histamine release.

Absorption

Allergens in ACTAIR consist mainly of proteins and glycoproteins. There is no direct bioavailability of intact allergens in the blood. Therefore, no pharmacokinetic studies in animals or in humans have been carried out to investigate the pharmacokinetic profile and metabolism of ACTAIR.

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

Products

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dosage, form, labeller, route of administration, and marketing period.
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Allergen Pack Dermatophagoides PteronyssinusSolution10000 [AU]/1mLIntradermal; SubcutaneousAlvix Laboratories2015-06-252018-03-08US flag
Allergenic Extract - Standardized Mite Dermatophagoides PteronyssinusLiquid5000 unit / mLIntradermal; SubcutaneousGreer LaboratoriesNot applicableNot applicableCanada flag
Allergenic Extract - Standardized Mite Dermatophagoides PteronyssinusLiquid10000 unit / mLIntradermal; SubcutaneousGreer Laboratories1999-03-15Not applicableCanada flag
Allergenic Extract Standardized Mite DpLiquid30000 unit / mLSubcutaneousHollister Stier, Unit Pharm, Division Of Miles Canada Inc.1992-12-311998-09-25Canada flag
Allergenic Extract Standardized Mite DpLiquid10000 unit / mLSubcutaneousHollister Stier, Unit Pharm, Division Of Miles Canada Inc.1992-12-311998-09-25Canada flag
Allergenic Extract Standardized Mite Dp (10,000 Au/ml)Solution10000 unit / mLPercutaneous; SubcutaneousJubilant Hollisterstier Llc1998-01-16Not applicableCanada flag
Allergenic Extract Standardized Mite Dp (30,000 Au/ml)Solution30000 unit / mLPercutaneous; SubcutaneousJubilant Hollisterstier Llc1997-01-03Not applicableCanada flag
Allergenic Extract, Standardized Mite, D.pteronyssinusLiquid10000 unit / mLIntradermal; Percutaneous; SubcutaneousAlk Abello, Inc.1997-09-15Not applicableCanada flag
Allergenic Extracts - Standardized Mite Dermatophagoides PteronyssinusLiquid30000 unit / mLIntradermal; SubcutaneousGreer LaboratoriesNot applicableNot applicableCanada flag
House Dust Mite, Dermatophagoides pteronyssinusInjection10000 [AU]/1mLCutaneous; Intradermal; SubcutaneousAllermed Laboratories, Inc.1986-12-24Not applicableUS flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ACARIZAXDermatophagoides pteronyssinus (6 AU) + Dermatophagoides farinae (6 AU)PowderOralบริษัท แอ๊บบอต ลาบอแรตอรีส จำกัด2018-03-28Not applicableThailand flag
AcarizaxDermatophagoides pteronyssinus (6 unit) + Dermatophagoides farinae (6 unit)TabletSublingualAlk Abelló A/S2017-11-06Not applicableCanada flag
Allergenic Extract - Standardized Mite MixDermatophagoides pteronyssinus (5000 unit / mL) + Dermatophagoides farinae (5000 unit / mL)LiquidIntradermal; SubcutaneousGreer Laboratories2002-08-20Not applicableCanada flag
Allergenic Extract Mixture Of Standardized Mites (15,000 Au/ml)Dermatophagoides pteronyssinus (15000 unit / mL) + Dermatophagoides farinae (15000 unit / mL)SolutionPercutaneous; SubcutaneousJubilant Hollisterstier Llc1998-01-16Not applicableCanada flag
Allergenic Extract Mixture Of Standardized Mites (5,000 Au/ml)Dermatophagoides pteronyssinus (5000 unit / mL) + Dermatophagoides farinae (5000 unit / mL)SolutionPercutaneous; SubcutaneousJubilant Hollisterstier Llc1998-01-16Not applicableCanada flag
Allergenic Extract Standardized Mite MixDermatophagoides pteronyssinus (15000 unit / mL) + Dermatophagoides farinae (15000 unit / mL)LiquidSubcutaneousHollister Stier, Unit Pharm, Division Of Miles Canada Inc.1992-12-311998-09-23Canada flag
Allergenic Extract Standardized Mite MixDermatophagoides pteronyssinus (5000 unit / mL) + Dermatophagoides farinae (5000 unit / mL)LiquidSubcutaneousHollister Stier, Unit Pharm, Division Of Miles Canada Inc.1992-12-311998-09-25Canada flag
Allergenic Extract, Standardized Mite MixedDermatophagoides pteronyssinus (5000 unit / mL) + Dermatophagoides farinae (5000 unit / mL)LiquidIntradermal; Percutaneous; SubcutaneousAlk Abello, Inc.2006-02-28Not applicableCanada flag
Mixture of Standardized MitesDermatophagoides pteronyssinus (5000 [AU]/1mL) + Dermatophagoides farinae (5000 [AU]/1mL)Injection, solutionIntradermal; SubcutaneousAntigen Laboratories, Inc.1991-10-22Not applicableUS flag
OdactraDermatophagoides pteronyssinus (6 [arb'U]/1) + Dermatophagoides farinae (6 [arb'U]/1)TabletSublingualALK-Abello A S2018-01-01Not applicableUS flag

Categories

ATC Codes
V01AA03 — House dust mites
Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
57L1Z5378K
CAS number
Not Available

References

General References
  1. FDA label [Link]
  2. Drug information [Link]
  3. FDA Approved Drug Products: ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use [Link]
PubChem Substance
347910576
RxNav
1116979
Wikipedia
House_dust_mite

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentAllergic Asthma Due to Dermatophagoides Pteronyssinus1
4CompletedTreatmentAllergic Reaction1
3Active Not RecruitingTreatmentAllergic Asthma Due to Dermatophagoides Farinae / Allergic Asthma Due to Dermatophagoides Pteronyssinus / House Dust Mite Allergy1
3Active Not RecruitingTreatmentAllergic Rhinitis Due to Dermatophagoides Farinae / Allergic Rhinitis Due to Dermatophagoides Pteronyssinus / House Dust Mite Allergy1
3CompletedTreatmentAllergic Rhinitis (AR) / Rhinoconjunctivitis, Allergic1
3RecruitingTreatmentRhinoconjunctivitis, Allergic1
Not AvailableCompletedNot AvailableAllergic Asthma Due to Dermatophagoides Farinae / Allergic Asthma Due to Dermatophagoides Pteronyssinus / House Dust Mite Allergy1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
PowderOral
Tablet, orally disintegratingOral
SolutionIntradermal; Subcutaneous10000 [AU]/1mL
LiquidIntradermal; Subcutaneous5000 unit / mL
SolutionPercutaneous; Subcutaneous
Injection, solution10000 AU/1ml
LiquidSubcutaneous10000 unit / mL
LiquidSubcutaneous30000 unit / mL
SolutionPercutaneous; Subcutaneous10000 unit / mL
SolutionPercutaneous; Subcutaneous30000 unit / mL
LiquidSubcutaneous
LiquidIntradermal; Percutaneous; Subcutaneous
LiquidIntradermal; Percutaneous; Subcutaneous10000 unit / mL
LiquidIntradermal; Subcutaneous30000 unit / mL
Injection, suspensionSubcutaneous
InjectionCutaneous; Intradermal; Subcutaneous10000 [AU]/1mL
TabletSublingual
TabletSublingual
Injection, solutionPercutaneous; Subcutaneous10000 [AU]/1mL
Injection, solutionSubcutaneous5000 [AU]/1mL
SolutionPercutaneous10000 [AU]/1mL
ConcentrateIntradermal; Percutaneous; Subcutaneous10000 [AU]/1mL
ConcentrateIntradermal; Percutaneous; Subcutaneous30000 [AU]/1mL
ConcentrateIntradermal; Percutaneous; Subcutaneous5000 [AU]/1mL
Injection, solutionIntradermal; Subcutaneous10000 [AU]/1mL
ConcentrateIntradermal; Percutaneous; Subcutaneous
Injection, solutionSubcutaneous
LiquidIntradermal; Subcutaneous10000 unit / mL
Injection, solutionIntradermal; Subcutaneous3000 [AU]/1mL
Injection, solutionIntradermal; Subcutaneous5000 [AU]/1mL
Injection, solutionSubcutaneous10000 [AU]/1mL
Injection, solutionIntradermal30 [AU]/1mL
Injection, solutionIntradermal300 [AU]/1mL
Injection, solutionPercutaneous; Subcutaneous30000 [AU]/1mL
LiquidIntradermal; Subcutaneous
Injection, solutionPercutaneous
Injection, solutionIntradermal; Subcutaneous
Solution10000 AU/1ml
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created at December 01, 2015 20:03 / Updated at July 01, 2022 12:31