Dosing & Uses
Dosage Forms & Strengths
sublingual tablet
- 300 IR (equivalent to ~ 9000 BAU)
- BAU (bioequivalent allergy units)
- IR (index of reactivity)
Allergic Rhinitis
Indicated as immunotherapy for grass pollen-induced allergic rhinitis (with or without conjunctivitis) confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the 5 grass species contained in the product
Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season
18-65 years: 300 IR SL qDay; give 1st dose in physician’s office and observe for 30 min
>65 years: Not approved
Dosing Considerations
Allergen contents
- Perennial Ryegrass (Lolium perenne)
- Kentucky bluegrass (Poa pratensis)
- Timothy grass (Phleum pratense)
- Orchard grass (Dactylis glomerata)
- Sweet Vernal grass (Anthoxanthum odoratum)
Dosage Forms & Strengths
sublingual tablet
- 100 IR (equivalent to ~3000 BAU)
- 300 IR (equivalent to ~ 9000 BAU)
- BAU (bioequivalent allergy units)
- IR (index of reactivity)
Allergic Rhinitis
Indicated as immunotherapy for grass pollen-induced allergic rhinitis (with or without conjunctivitis) confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the 5 grass species contained in the product
<5 years: Safety and efficacy not established
5-17 years
- Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season
- Day 1: 100 IR SL once (in physician’s office and observe for 30 min)
- Day 2: 200 IR SL once
- Day 3 and thereafter: 300 IR SL qDay
Dosing Considerations
Allergen contents
- Perennial Ryegrass (Lolium perenne)
- Kentucky bluegrass (Poa pratensis)
- Timothy grass (Phleum pratense)
- Orchard grass (Dactylis glomerata)
- Sweet Vernal grass (Anthoxanthum odoratum)
Not approved for persons older than 65 years
Adverse Effects
>10% (Adults)
Oral pruritus (25.1%)
Throat irritation (22%)
1-10% (Adults)
Ear pruritus (8.4%)
Mouth edema (8.2%)
Tongue pruritus (7.9%)
Cough (7.3%)
Oropharyngeal pain (5.1%)
Lip edema (4.4%)
Paraesthesia, oral (4.3%)
Abdominal pain (4.2%)
Dyspepsia (3.9%)
Pharyngeal edema (3.8%)
Tongue edema (2.7%)
Urticaria (2.3%)
Hypoesthesia, oral (2.2%)
Stomatitis (2.1%)
1-10% (Children/adolescents)
Asthma (7.1%)
Tonsillitis (5.8%)
URI (3.9%)
Lip pruritus (3.2%)
Atopic dermatitis (3.2%)
Dysphonia (2.6%)
Postmarketing Reports
Anaphylactic reaction
Oral allergy syndrome
Flushing
Dyspnea
Laryngeal edema
Diarrhea
Warnings
Black Box Warnings
Can cause life-threatening allergic reactions (eg, anaphylaxis, severe laryngopharyngeal edema)
Do not administer to patients with severe, unstable, or uncontrolled asthma
Administer 1st dose in a doctor’s office and observe patient for at least 30 minutes
Patients should be prescribed auto-injectable epinephrine, trained on its appropriate use, and instructed to seek immediate medical care upon its use
May not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction (eg, markedly compromised lung function [either chronic or acute], unstable angina, recent MI, significant arrhythmia, uncontrolled hypertension)
Patients taking drugs that inhibit bronchodilator or epinephrine effects (eg, beta-blockers, alpha-blockers, ergot alkaloids) may be unresponsive to the usual doses of epinephrine
May not be suitable for patients taking drugs that potentiate epinephrine effect (eg, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine)
Carefully observe patients who receive epinephrine while taking cardiac glycosides or diuretics for the development of cardiac arrhythmias
Contraindications
Severe, unstable, or uncontrolled asthma
History of any severe systemic or local reaction to sublingual allergen immunotherapy
Hypersensitivity to inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate)
History of eosinophilic esophagitis
Cautions
Potential for severe allergic reaction (see Black Box Warnings and Contraindications)
Must be prescribed with auto-injectable epinephrine (see Black Box Warnings)
Not studied with moderate or severe asthma or any subjects who required daily medication
Withhold dose if patient experiencing an acute asthma exacerbation; re-evaluate patients with recurrent asthma exacerbations and consider discontinuing Oralair
Not studied in individuals receiving concomitant allergen immunotherapy
Stop treatment and allow complete healing of the oral cavity in patients with oral inflammation (eg, oral lichen planus, mouth ulcers or thrush) or oral wounds (eg, oral surgery, dental extraction)
Risks may be increased when treatment is initiated during the grass pollen season
Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy; discontinue Oralair and consider diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain
Pregnancy & Lactation
Pregnancy
Available human data do not establish the presence or absence associated risks during pregnancy, labor, and delivery
Lactation
Data are not available to assess effects on the breastfed child or on milk production/excretion
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Precise mechanism of allergen immunotherapy is not known
Allergen immunotherapy sublingual tablet consisting of 5 purified and calibrated pollen extracts: Perennial Ryegrass (Lolium perenne), Kentucky bluegrass (Poa pratensis), Timothy grass (Phleum pratense), Orchard grass (Dactylis glomerata), and Sweet Vernal grass (Anthoxanthum odoratum)
Administration
SL Administration
Administer to children only under adult supervision
Instruct patients to avoid swallowing for about 1 minute following SL administration
Wash hands after handling the tablet
Do not take with food or beverage; avoid food or beverages for 5 minutes after taking the SL tablet
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Protect from moisture
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Formulary
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