"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 Tablet
SEVERE ALLERGIC REACTIONS
- ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction (See WARNINGS AND PRECAUTIONS).
- Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma (See CONTRAINDICATIONS).
- Observe patients in the office for at least 30 minutes following the initial dose (See WARNINGS AND PRECAUTIONS).
- Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use (See WARNINGS AND PRECAUTIONS).
- ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction (See WARNINGS AND PRECAUTIONS).
- ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers (See WARNINGS AND PRECAUTIONS).
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: 4/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Oralair Information
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