Indications for: ODACTRA

House dust mite-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or positive skin testing to licensed house dust mite allergen extracts. Not for immediate relief of allergic symptoms.

Adult Dosage:

Give 1st dose under physician supervision; observe ≥30mins for any signs/symptoms of severe allergic reaction; if tolerated, subsequent doses may be taken at home. 12–65yrs: 1 tab daily. Allow complete dissolution under the tongue within 10secs; do not swallow for at least 1min. Avoid food or beverage for 5mins after dosing. Wash hands after handling tab.

Children Dosage:

<12yrs: not established.

ODACTRA Contraindications:

Severe, unstable or uncontrolled asthma. History of any severe systemic or local allergic reaction to sublingual allergen immunotherapy. History of eosinophilic esophagitis.

Boxed Warning:

Severe allergic reactions.

ODACTRA Warnings/Precautions:

Risk of severe allergic reactions (eg, anaphylaxis, laryngopharyngeal swelling); discontinue if occurs. Prescribe auto-injectable epinephrine for emergency use. Underlying conditions that may reduce survival of a serious allergic reaction after epinephrine use (eg, markedly compromised lung function, severe mast cell disorder, unstable angina, recent MI, significant arrhythmia, uncontrolled HTN). Upper airway compromise: consider discontinuing if persistent adverse reactions in the mouth or throat develop. Discontinue if severe or persistent gastroesophageal symptoms including dysphagia or chest pain develop. Withhold therapy in acute asthma exacerbation; consider discontinuing if recurrent. Interrupt therapy for oral inflammation or wounds to allow complete healing. Elderly (>65yrs). Pregnancy. Nursing mothers.

ODACTRA Classification:

Allergen extract.

ODACTRA Interactions:

Concomitant other allergen immunotherapy: not studied; may increase risk of local or systemic adverse reactions. Avoid concomitant drugs that can potentiate or inhibit effects of epinephrine (eg, beta-adrenergic blockers, alpha-adrenergic blockers, ergot alkaloids, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine, [cardiac glycosides, diuretics; monitor for arrhythmias]).

Adverse Reactions:

Throat irritation/tickle, mouth or ear itching, swelling (uvula/back of mouth, lips, tongue, throat), nausea, tongue pain, tongue or mouth ulcer/sore, stomach pain, taste alteration; eosinophilic esophagitis.

Generic Drug Availability:


How Supplied: