essants, levothyroxine sodium, monoamine oxidase inhibitors and certain antihistamines: The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine.
Cardiac glycosides, diuretics: Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.
5.3 Eosinophilic Esophagitis
Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy [see Contraindications (4) and Adverse Reactions (6.2)]. Discontinue ORALAIR and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
5.4 Asthma
ORALAIR has not been studied in subjects with moderate or severe asthma or any subjects who required daily medication.
Immunotherapy with ORALAIR should be withheld if the patient is experiencing an acute asthma exacerbation. Reeva luate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR.
5.5 Concomitant Allergen Immunotherapy
ORALAIR has not been studied in subjects receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.
5.6 Oral Inflammation
Stop treatment with ORALAIR to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers or thrush) or oral wounds, such as those following oral surgery or dental extraction.
5.7 Initiation of ORALAIR Therapy during Grass Pollen Season
The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.
6 ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients were: oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in practice.
Adults
Overall, in 6 placebo-controlled clinical trials, 1,038 adults 18 through 65 years of age received at least one dose of ORALAIR 300IR, of whom 611 (59%) completed at least four months of therapy. Of study participants, 56% were male, 17% had a history of mild intermittent asthma at study entry, and 64% were polysensitized. Data on race and ethnicity were not systematically captured in the five European studies (N=805). In the US study (N=233), a limited number of patients reported their race as other than White/Caucasian (Black/African American: 5.6%, Asian: 2.6%, Other: 2.1%) or their ethnicity as Hispanic or Latino (3.0%). Adverse events were captured on a daily diary card that did not solicit for specific adverse events.
Across the six clinical studies, adverse reactions reported at an incidence of ≥2% of ORALAIR recipients and at a greater incidence than that in participants treated with placebo are listed in Table 2.
Table 2. Adverse Reactions Reported by ≥2% of Adults Receiving ORALAIR 300 IR and at a Greater Incid |
