"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"...
(Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Sublingual Tablets
SEVERE ALLERGIC REACTIONS
- ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
- Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma.
- Observe patients in the office for at least 30 minutes following the initial dose.
- Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
- ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
- ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.
ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).
ORALAIR is available as a sublingual tablet in the following strengths:
- 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units)
- 300 IR (equivalent to approximately 9000 BAU
Inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate.
Last reviewed on RxList: 5/2/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Oralair Information
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Allergies & Asthma
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