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Sublingual immunotherapy (SLIT) tablets: Labeling differences among United States products

	Grastek	Oralair	Ragwitek	Odactra
Components	Timothy grass pollen extract Cross-reactive with: Timothy Orchard Kentucky Blue Perennial Rye Sweet Vernal Fescue Redtop	Pollen extracts of five grasses: Timothy Orchard Kentucky Blue Perennial Rye Sweet Vernal	Short ragweed pollen extract	House dust mite allergen extract from Dermatophagoides farinae and D. pteronyssinus
Indications	Grass pollen-induced allergic rhinitis with or without conjunctivitis	Grass pollen-induced allergic rhinitis with or without conjunctivitis	Short ragweed pollen-induced allergic rhinitis with or without conjunctivitis	Dust mite-induced allergic rhinitis with or without conjunctivitis
Approved for ages	5 to 65 years	10 to 65 years	5 to 65 years	18 to 65 years
Required testing	Positive skin test or in vitro testing for IgE antibodies to Timothy grass or any of the cross-reactive grass species	Positive skin test or in vitro testing for IgE antibodies to any of the 5-grass species in the tablet	Positive skin test or in vitro testing for IgE antibodies to short ragweed	Positive skin test with a house dust mite extract or in vitro testing for IgE antibodies to Dermatophagoides farinae or D. pteronyssinus
Dose	2800 BAU single dose tablet, daily	300 IR in adults (ages: 18 to 65) In children (ages: 10 to 17) step-up over three days, as tolerated: Day 1: 100 IR Day 2: 2× 100 IR Day 3: 300 IR	12 Amb a 1 unit single dose tablet, daily	12 SQ-HDM unit single dose tablet, daily
Method of administration	Place tablet under the tongue until it completely dissolves; do not swallow for at least one minute	Place tablet under tongue for at least one minute or until completely dissolved, and then swallow	Place tablet under the tongue until it completely dissolves; do not swallow for at least one minute	Place tablet under the tongue until it completely dissolves; do not swallow for at least one minute
Initiation	12 weeks prior to grass season	16 weeks prior to grass season	12 weeks prior to ragweed season	Can be started anytime
Duration	Prior to and through relevant grass season; may be continued on a perennial basis over three years for sustained effectiveness	Prior to and through relevant grass season	Prior to and through relevant ragweed season	Year-round
Data on safety of reinitiating treatment after a missed dose	In clinical trials, treatment interruptions for up to seven days were allowed	Data not available	In clinical trials, treatment interruptions for up to seven days were allowed	In clinical trials, treatment interruptions for up to seven days were allowed
Contraindications	Severe unstable or uncontrolled asthma History of any severe systemic allergic reaction History of any severe local reaction after taking SLIT Hypersensitivity to inactive ingredients in the product History of eosinophilic esophagitis	Severe unstable or uncontrolled asthma History of any severe systemic allergic reaction History of any severe local reaction after taking SLIT Hypersensitivity to inactive ingredients in the product History of eosinophilic esophagitis	Severe unstable or uncontrolled asthma History of any severe systemic allergic reaction History of any severe local reaction after taking SLIT Hypersensitivity to inactive ingredients in the product History of eosinophilic esophagitis	Severe unstable or uncontrolled asthma History of any severe systemic allergic reaction History of any severe local reaction after taking SLIT Hypersensitivity to inactive ingredients in the product History of eosinophilic esophagitis
Inactive ingredients	Gelatin (fish source), mannitol, sodium hydroxide	Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, lactose monohydrate	Gelatin (fish source), mannitol, sodium hydroxide	Gelatin (fish source), mannitol, sodium hydroxide
Asthma patients included in clinical trials	Not studied in patients with moderate or severe asthma or in patients who require daily medication to treat asthma	Not studied in patients with moderate or severe asthma or in any subjects who require daily medication to treat asthma	Trials allowed patients who required daily low doses of inhaled glucocorticoids to treat asthma	Trials allowed patients with mild-to-moderate asthma that required, at most, a medium daily dose of an inhaled glucocorticoid to treat asthma

This table highlights differences in the product labeling among tablet products for SLIT. Several important safety issues, which are the same for all products, are not included. Please refer to the accompanying UpToDate topic on sublingual immunotherapy for allergic rhinitis for a discussion of additional safety issues, use in patients with asthma, recommendations for administration of initial dose, data on safety of initiating treatment during pollen season, and evaluation of patients with asthma exacerbations or recurrent asthma episodes while receiving SLIT.

IgE: immunoglobulin E; BAU: biologic allergy units; IR: index of reactivity; SQ-HDM: standardized units of potency for house dust mite allergen extract.

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