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House dust mite sublingual tablet: Drug information

House dust mite sublingual tablet: Drug information
(For additional information see "House dust mite sublingual tablet: Patient drug information" and see "House dust mite sublingual tablet: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians 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.

Brand Names: US
  • Odactra
Brand Names: Canada
  • Acarizax
Pharmacologic Category
  • Allergen-Specific Immunotherapy
Dosing: Adult
House dust mite-induced allergic rhinitis

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "House dust mite sublingual tablet: Pediatric drug information")

House dust mite-induced allergic rhinitis

House dust mite-induced allergic rhinitis: Children ≥12 years and Adolescents: Sublingual: One tablet once daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults unless otherwise specified.

>10%:

Dermatologic: Pruritus of the ear (50% to 52%)

Gastrointestinal: Glossalgia (1% to 25%; including tongue discomfort), nausea (14% to 17%), oral itching (children and adolescents: 73%; adults: 61%), oral mucosa ulcer (10% to 11%), stomach pain (children and adolescents: 23%; adults: 11%), tongue ulcer (12% to 13%)

Hypersensitivity: Mouth edema (20%, uvula/back of mouth), swelling of lips (18% to 20%), swollen tongue (16% to 19%)

Respiratory: Pharyngeal edema (14% to 18%; can be severe), throat irritation (67% to 73%)

1% to 10%:

Cardiovascular: Chest discomfort (1% to 2%), chest pain (children and adolescents: 1%), flushing (children and adolescents: 1%)

Dermatologic: Lip pruritus (adults: 1%), pruritus (children and adolescents: 2%), urticaria (adults: 1%)

Gastrointestinal: Aphthous stomatitis (children and adolescents: 1%), diarrhea (7% to 8%), dysgeusia (4% to 10%), dyspepsia (adults: 2% to 3%), dysphagia (1%), enlargement of salivary glands (children and adolescents: 1%), eosinophilic esophagitis (≤1%), gastroesophageal reflux disease (adults: 2%), mouth pain (3% to 4%), oral mucosal erythema (adults: 2%), oral paresthesia (5% to 9%), stomatitis (2% to 3%), tongue pruritus (3% to 5%), vomiting (3% to 4%)

Nervous system: Noncardiac chest pain (children and adolescents: 1%), tightness in chest and throat (children and adolescents: 1%)

Neuromuscular & skeletal: Arthralgia (children and adolescents: 1%), neck pain (children and adolescents: 1%)

Ophthalmic: Eye pruritus (1% to 2%), swelling of eye (children and adolescents: 1%)

Otic: Otalgia (children and adolescents: 1%)

Respiratory: Acute sinusitis (children and adolescents: 1%), dry throat (adults: 1%), oropharyngeal pain (1%), pharyngeal erythema (adults: 2%), rhinorrhea (children and adolescents: 1%), sneezing (adults: 2%), tonsillar hypertrophy (children and adolescents: 1%), upper respiratory tract infection (adults: 2%)

Frequency not defined (any population): Respiratory: Laryngeal edema (can be severe)

Postmarketing (any population):

Dermatologic: Erythema of skin

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Respiratory: Cough

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).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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: 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: 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:

• Appropriate patient selection: 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: 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.

• 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.

Dosage Forms: US

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

Solution, Injection:

Generic: 10000 AU/ML (10 mL, 50 mL); 15000-15000 AU/ML (50 mL)

Solution, Subcutaneous:

Generic: 10000 AU/ML (5 mL, 10 mL)

Tablet Sublingual, Sublingual:

Odactra: 12 SQ-HDM

Generic Equivalent Available: US

May be product dependent

Pricing: US

Solution (Dust Mite Mixed Allergen Ext Injection)

10000AU/ML (per mL): $58.65

30000AU/ML (per mL): $109.70

Solution (Dust Mite Mixed Allergen Ext Subcutaneous)

10000AU/ML (per mL): $57.01

Sublingual (Odactra Sublingual)

12SQ-HDM (per each): $13.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution, Subcutaneous:

Generic: 10000 AU/ML (5 mL, 16 mL, 30 mL, 50 mL)

Tablet Sublingual, Sublingual:

Acarizax: 12 SQ-HDM

Administration: Adult

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.

Administration: Pediatric

Note: Administer the first dose in a health care 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. Auto-injectable epinephrine should be made available to patients.

Sublingual: 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.

Missed doses: Data regarding restarting treatment after missing a dose are limited; in clinical trials, treatment interruptions ≤7 days were allowed.

Use: Labeled Indications

House dust mite-induced allergic rhinitis: Treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or D. pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts in patients 12 to 65 years of age.

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

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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

Breastfeeding Considerations

It is not known if house dust mite allergen extract is present in breast milk.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

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

Mechanism of Action

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Acarizax | Acaroid | Acarovac | Actair | Lais milben;
  • (BE) Belgium: Acarizax | Orylmyte;
  • (BG) Bulgaria: Actair;
  • (CH) Switzerland: Acarizax;
  • (CO) Colombia: Extracto alergenico acaros;
  • (CZ) Czech Republic: Acarizax;
  • (DE) Germany: Acarizax | Lais | Tyromilbe;
  • (EE) Estonia: Acarovac plus;
  • (ES) Spain: Acarizax;
  • (FI) Finland: Acarizax;
  • (FR) France: Acarizax | Orylmyte;
  • (IE) Ireland: Acarizax;
  • (JP) Japan: Miticure;
  • (KR) Korea, Republic of: Acarizax | Actair maintenance treatment | Lais;
  • (LU) Luxembourg: Acarizax | Orylmyte;
  • (LV) Latvia: Lais;
  • (NL) Netherlands: Acarizax | Actair;
  • (NO) Norway: Acarizax;
  • (NZ) New Zealand: Acarizax;
  • (PL) Poland: Acarizax;
  • (PR) Puerto Rico: Odactra;
  • (QA) Qatar: Acarizax;
  • (RU) Russian Federation: Allergen from Dermatophagoides farinae for diagnosis and treatment | Lais dermatophagides;
  • (SE) Sweden: Acarizax | Alutard SQ dermatophagoides farinae;
  • (SI) Slovenia: Actair;
  • (SK) Slovakia: Acarizax;
  • (TW) Taiwan: Acarizax
  1. Acarizax (house dust mite allergen extract) [product monograph]. Hørsholm, Denmark: ALK-Abello; January 2022.
  2. Larenas-Linnemann DE, Hauswirth DW, Calabria CW, Sher LD, Rank MA. American Academy of Allergy, Asthma & Immunology membership experience with allergen immunotherapy safety in patients with specific medical conditions. Allergy Asthma Proc. 2016;37(5):112-122. [PubMed 27657518] 10.2500/aap.2016.37.3981.
  3. Leith E, Bowen T, Butchey J, et al. Consensus Guidelines on Practical Issues of Immunotherapy-Canadian Society of Allergy and Clinical Immunology (CSACI). Allergy Asthma Clin Immunol. 2006;2(2):47-61. [PubMed 20525157]
  4. Odactra (house dust mite allergen extract) [prescribing information]. Swindon, Wiltshire, UK: Catalent Pharma Solutions Limited; January 2023.
  5. Oykhman P, Kim HL, Ellis AK. Allergen immunotherapy in pregnancy. Allergy Asthma Clin Immunol. 2015;11:31. [PubMed 26561490] 10.1186/s13223-015-0096-7.
  6. Shaikh WA, Shaikh SW. A prospective study on the safety of sublingual immunotherapy in pregnancy. Allergy. 2012;67(6):741-743. [PubMed 22486626] 10.1111/j.1398-9995.2012.02815.x.
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