nts then entered two years of immunotherapy-free follow-up (Year 4 and Year 5). The results of the analysis of the daily Combined Score for ORALAIR (4M) for treatment Years 1-3 are summarized in Table 6. Data are insufficient to demonstrate efficacy for one or two years after discontinuation of ORALAIR.
Table 6. Analysis of Daily Combined Score for Each Grass Pollen Period (Long Term study)
LS: Least Squares
Pediatric Study
In this study, 278 children and adolescents received ORALAIR or placebo starting approximately 4 months prior to the grass-pollen season and continuing for the duration of the pollen season. The results of the daily CS, daily RTSS, and daily RMS are summarized in Table 7.
Table 7. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), Daily Rescue Medication Score (RMS) during the Grass Pollen Period (Pediatric study)
LS: Least Squares
Allergen Environmental Chamber Study
In an allergen environmental chamber study, 89 adults with grass pollen-associated allergic rhinoconjunctivitis were challenged with four of the five grass pollens contained in ORALAIR at baseline and after 4 months of treatment with ORALAIR (n=45) or placebo (n=44). The average Rhinoconjunctivitis Total Symptom Score (RTSS) of each group during the 4 hours of the allergen challenge was assessed; use of rescue medication was not permitted. The results of this study are shown in Table 8.
Table 8. Average Rhinoconjunctivitis Total Symptom Score (RTSS) during Grass Pollen Allergen Challenge in an Environmental Exposure Chamber after 4 months of ORALAIR or placebo
LS: Least Squares
Primary efficacy analysis
16 HOW SUPPLIED/STORAGE AND HANDLING
ORALAIR is available as a sublingual tablet equivalent to 100 IR and 300 IR of five grass mixed pollens allergen extract.
Storage: Store at controlled room temperature (20°C-25°C/68°F-77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the Medication Guide and to keep ORALAIR and all medicines out of the reach of children.
Inform patients that ORALAIR is used for sublingual immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis and is not indicated for the immediate relief of allergy symptoms.
Severe Allergic Reactions
Advise patients that ORALAIR may cause systemic allergic reactions, including anaphylactic reactions, and severe local allergic reactions [See Warnings and Precautions (5.1)].
Educate patients about the signs and symptoms of a severe systemic allergic reaction and a severe local allergic reaction. The signs and symptoms of a severe allergic reaction may include: syncope, dizziness, hypotension, tachycardia, dyspnea, wheezing, bronchospasm, chest discomfort, cough, abdominal pain, vomiting, diarrhea, rash, pruritus, flushing, and urticaria [See Warnings and Precautions (5.2)].
Ensure that patients have injectable epinephrine available and are appropriately trained in its use. Instruct patients who experience a severe allergic reaction to seek immediate medical care, discontinue therapy, and resume treatment only at the instruction of a physician [See Warnings and Precautions (5.2)].
Inform the patient that the first dose of ORALAIR is administered in a healthcare setting under the supervision of a physician and s/he will be monitored for at least 30 minut |
