House Dust Mite Immunotherapy

House dust mite immunotherapy is used indicated for dust mite-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, in people aged 18-65 years.

House dust mite immunotherapy is available under the following different brand names: Odactra.

Dosages of House Dust Mite Immunotherapy:

Dosage Forms and Strengths

Tablet, Sublingual

• 12 SQ-HDM
• SQ is a method of standardization of biological potency, major allergen content, and complexity of allergen extract; HDM is an abbreviation for house dust mite

Dosage Considerations – Should be Given as Follows:

Allergic Rhinitis

• Sublingual allergy immunotherapy (SLIT) tablet indicated for dust mite-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, in people aged 18-65 years
• 1 tablet sublingually (SL) once daily
• Children under 18 years: Safety and efficacy not established
• Adults over 65 years: Safety and efficacy not established

Common side effects of house dust mite immunotherapy include:

• Itching in the ear
• Itching in the mouth
• Swelling of the uvula/back of the mouth
• Swelling of the lips
• Swelling of the tongue
• Nausea
• Tongue pain
• Tongue ulcer/sore on the tongue
• Stomach pain
• Mouth ulcer/sore in the mouth
• Throat irritation/tickle
• Throat swelling
• Taste alteration/food tastes different
• Diarrhea

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• House dust mite immunotherapy has no listed severe interactions with other drugs.
• House dust mite immunotherapy has no listed serious interactions with other drugs.
• House dust mite immunotherapy has no listed moderate interactions with other drugs.
• House dust mite immunotherapy has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains house dust mite immunotherapy. Do not take Odactra if you are allergic to house dust mite immunotherapy or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

• Life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restriction, may occur
• Not for administration to patients with severe, unstable, or uncontrolled asthma
• Observe patients for at least 30 min following the initial dose
• Prescribe patients auto-injectable epinephrine; instruct and train patients on appropriate use and instruct patients to seek immediate care upon use
• Administration may not be suitable for patients with certain underlying medical conditions that may reduce the ability to survive serious allergic reactions or for patients unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers

Contraindications

• Severe, unstable, or uncontrolled asthma
• History of a severe systemic allergic reaction
• History of severe local reaction after taking sublingual allergen immunotherapy
• History of eosinophilic esophagitis
• Hypersensitivity to product or components

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using House Dust Mite Immunotherapy?”

Long-Term Effects

• See "What Are Side Effects Associated with Using House Dust Mite Immunotherapy?”

Cautions

• Therapy may cause systemic allergic reactions, including anaphylaxis, which may be life-threatening (see Black Box warning)
• May cause a local reaction in mouth or throat that could compromise upper airway; discontinue therapy if patient experiences persistent and escalating adverse reactions in mouth or throat
• Eosinophilic esophagitis may occur; discontinue therapy and consider the diagnosis of eosinophilic esophagitis in patients who experience persistent gastroesophageal symptoms including dysphagia or chest pain
• Withhold immunotherapy if patient experiences acute asthma exacerbation; reevaluate patients who experience recurrent asthma exacerbations; discontinue therapy if necessary
• Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy
• Stop therapy and allow complete healing of oral cavity in patients with oral inflammation, including oral lichen planus, mouth ulcers or thrush, or oral wounds such as those following oral surgery or dental extraction

Drug interactions overview

• Patients taking beta-adrenergic blockers may be unresponsive to usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis; beta-adrenergic blockers may antagonize cards stimulating and bronchodilating effects of epinephrine
• Patients taking alpha-adrenergic blockers may be unresponsive to usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis; alpha-adrenergic blockers may antagonize vasoconstricting and hypertensive effects of epinephrine; ergot alkaloids may also reverse pressor effects of epinephrine
• Adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine and diphenhydramine
• Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias

Pregnancy and Lactation

• The available data on the use of house dust mite immunotherapy in pregnant women are insufficient to inform associated risks in pregnancy. In a fetal/embryo developmental toxicity study performed in mice, administration of house dust mite immunotherapy during gestation did not reveal adverse developmental outcomes in fetuses. Consult your doctor.
• Data are not available to assess the effects of house dust mite immunotherapy on breastfed children or milk production and excretion in nursing women. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for house dust mite immunotherapy and any potential adverse effects on breastfed infants from the drug or the underlying maternal condition.