Grass pollens allergen extract

Indications

Grass pollens allergen extract is used for: Allergic Rhinitis

Adult Dose

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

Child Dose

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

Renal Dose

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

Contra Indications

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

Precautions

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

Interactions

Adverse Effects

Side effects of Grass pollens allergen extract : >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%)

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)