CATIONS
Severe, unstable or uncontrolled asthma (4)
History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy (4)
A history of eosinophilic esophagitis (4)
Hypersensitivity to any of the inactive ingredients contained in this product (4)
WARNINGS AND PRECAUTIONS
Inform patients of the signs and symptoms of severe allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. (5.1)
In case of oral inflammation or wounds, stop treatment with ORALAIR to allow complete healing of the oral cavity. (5.5)
ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients were: oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain (6)
To report SUSPECTED ADVERSE REACTIONS, contact Stallergenes at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.
ORALAIR is not indicated for the immediate relief of allergy symptoms.
2 DOSAGE AND ADMINISTRATION
For sublingual use only.
2.1 Dose
For adults 18 through 65 years of age, the dose is 300 IR (index of reactivity) daily. For children and adolescents 10 through 17 years of age, the dose is increased over the first three days as shown in Table 1.
Table 1. Dosage for Adults and Children for the Days 1-3 (and following)
2.2 Administration
Administer the first dose of ORALAIR in a healthcare setting in which acute allergic reactions can be treated under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. After receiving the first dose of ORALAIR, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.
Administer ORALAIR to children under adult supervision.
Remove the ORALAIR tablet from the blister just prior to dosing.
Place the ORALAIR tablet immediately under the tongue until complete dissolution for at least 1 minute before swallowing.
Wash hands after handling the ORALAIR tablet.
Do not take the ORALAIR tablet with food or beverage. To avoid swallowing allergen extract, food or beverage should not be taken for 5 minutes following dissolution of the tablet.
Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season.
Data regarding the safety of starting treatment during the pollen season or restarting treatment after missing a dose of ORALAIR are not available.
It is recommended that auto-injectable epinephrine be made available to patients prescribed ORALAIR. Patients who are prescribed epinephrine while receiving immunotherapy should be instructed in the proper use of emergency self-injection of epinephrine [See Warnings and Precautions (5.2)].
3 DOSAGE FORMS AND STRENGT |
