"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
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.
DOSAGE AND ADMINISTRATION
For sublingual use only.
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)
|Day 1||Day 2||Day 3 and following|
|10-17||100 IR||2x 100 IR||300 IR|
|18-65||300 IR||300 IR||300 IR|
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].
Dosage Forms And Strengths
ORALAIR tablets are available as follows:
- ORALAIR 100 IR tablets are round and biconvex, slightly speckled white to beige with “100” engraved on both sides
- ORALAIR 300 IR tablets are round and biconvex, slightly speckled white to beige with “300” engraved on both sides
Storage And Handling
ORALAIR is available as a sublingual tablet equivalent to 100 IR and 300 IR of five grass mixed pollens allergen extract.
|Children and Adolescents Sample Kit (10 to 17 years of age)||One box of the 100 IR Starter Pack Two boxes of the 300 IR Sample Packs||NDC 59617-0020-1|
|Adult Sample Kit (18 to 65 years of age)||One box of 300 IR Starter Pack Two boxes of 300 IR Sample Packs||NDC 59617-0025-1|
|Children and Adolescents Starter Pack (10 to 17 years of age)||1 blister pack of three 100 IR tablets||NDC 59617-0010-1|
|Adult Starter Pack (18 to 65 years of age)||1 blister pack of three 300 IR tablets||NDC 59617-0016-1|
|Sample Pack||1 blister pack of three 300 IR tablets||NDC 59617-0015-3|
|Commercial Pack||1 blister pack of thirty 300 IR tablets||NDC 59617-0015-2|
Storage: Store at controlled room temperature (200C-25°C/680F-77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.
Manufactured by: Stallergenes S.A., Antony, 92183, France, U.S. License # 1893. Distributed by: GREER Laboratories, Inc., Lenoir, N.C. 28645
Last reviewed on RxList: 4/15/2014
This monograph has been modified to include the generic and brand name in many instances.
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