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Odactra
house dust mite allergen extract
Black Box Warnings .
Severe Hypersensitivity Rxn
life-threatening rxns incl. anaphylaxis and severe laryngopharyngeal restriction may occur; do not give to pts w/ severe, unstable or uncontrolled asthma; tx may not be suitable for pts w/ underlying medical conditions that may decr. ability to survive serious hypersens. rxns; observe pts for s/sx hypersensitivity rxn for at least 30min after 1st dose; prescribe epinephrine and instruct pts or parents/guardians on appropriate use and to seek immed. medical care upon use; allergen immunotherapy may not be suitable for pts potentially unresponsive to epinephrine or inhaled bronchodilators, such as pts taking beta-blockers
Adult Dosing .
Dosage forms: SL TAB: 12 SQ-HDM
allergic rhinitis, house dust mite-induced
- [18-65 yo]
- Dose: 1 tab SL qd
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: SL TAB: 12 SQ-HDM
allergic rhinitis, house dust mite-induced
- [5 yo and older]
- Dose: 1 tab SL qd
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity rxn hx, severe
- sublingual allergen immunotherapy-associated local rxn hx, severe
- asthma, severe
- asthma, unstable
- asthma, uncontrolled
- eosinophilic esophagitis hx
- oral wound, unhealed
- oral inflammation, unhealed
- caution: allergen immunotherapy use, concurrent
Drug Interactions .
Overview
house dust mite allergen extract
allergen
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- angioedema
- laryngopharyngeal edema
- eosinophilic esophagitis
Common Reactions
- throat irritation
- pruritus
- pharyngeal edema
- lip swelling
- tongue swelling
- nausea
- tongue pain
- abdominal pain
- oral ulcer
- taste changes
- diarrhea
- vomiting
- oral paresthesia
- oral pain
- stomatitis
- dyspepsia (adult pts)
- chest discomfort (peds pts)
- pharyngeal erythema (adult pts)
Safety/Monitoring .
Monitoring Parameters
s/sx hypersensitivity rxn for at least 30min after 1st dose
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though risk of fetal harm not expected based on human data w/ other allergen immunotherapy agents
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: unknown
Excretion: unknown; Half-life: unknown
Subclass: Allergen Immunotherapy
Mechanism of Action
exact mechanism of action unknown; alters immune response and promotes tolerance through repeated allergen-specific exposure
Formulary .
No Formulary Selected
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