"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"...
(Short Ragweed Pollen Allergen Extract) Tablets
SEVERE ALLERGIC REACTIONS
- RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. (See WARNINGS AND PRECAUTIONS).
- Do not administer RAGWITEK 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).
- RAGWITEK 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).
- RAGWITEK 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).
RAGWITEK tablets contain pollen allergen extract from Short Ragweed (Ambrosia artemisiifolia).
RAGWITEK is a sublingual orally disintegrating tablet that dissolves rapidly.
RAGWITEK is available as a tablet of 12 Amb a 1-U of short ragweed pollen allergen extract.
Inactive ingredients: gelatin NF (fish source), mannitol USP, and sodium hydroxide NF.
Last reviewed on RxList: 5/2/2014
This monograph has been modified to include the generic and brand name in many instances.
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