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ODACTRA
Allergies
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Drug Name:

ODACTRA Rx

Generic Name and Formulations:
House dust mite allergen extract (Dermatophagoides farinae, Dermatophagoides pteronyssinus) 12 SQ-HDM; sublingual tabs.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for ODACTRA:

House 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. Not for immediate relief of allergic symptoms.

Adult:

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. 18–65yrs: 1 tab daily. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5 mins after dosing. Wash hands after handling tab.

Children:

<18yrs: not established.

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.

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, unstable angina, recent MI, significant arrhythmia, uncontrolled HTN). Upper airway compromise: consider discontinuing if persistent adverse reactions in the mouth or throat develops. 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.

Pharmacological Class:

Allergen extract.

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 (discontinue if occurs).

Generic Availability:

NO

How Supplied:

Blisters—30

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