grass pollens allergen extract (Rx)

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Brand and Other Names:Oralair

Dosing & Uses

AdultPediatricGeriatric

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)
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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)

Administration

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

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)
more...

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

<10 years: Safety and efficacy not established

10-17 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)

Administration

Administer 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

Not approved for persons older than 65 years

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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

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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

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if distributed in human breast milk; caution advised

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.

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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)

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
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