Odactra Approved for Dust Mite Allergy
March 1, 2017 – The U.S. FDA approved Odactra (house dust mite allergen extract), manufactured by ALK-Abellot. Odactra is for adults between 18 years and 65 years of age who have nasal inflammation (allergic rhinitis) that may be accompanied by eye inflammation (conjunctivitis) from an allergy to dust mites. Odactra is an oral immunotherapy to be taken as sublingual tablets that dissolves under the tongue, and contains small amounts of dust mite allergens. In clinical studies, patients using it experience a decrease in symptoms of about 16% to 18%. Full results may take up to 14 weeks to be achieved. Recommended dosing is once a day continually, with the first dose in a physician’s office or clinic to be sure the allergens in Odactra do not result in serious side effects. A boxed warning on the labeling cautions patients that severe allergic reactions, such as potentially life-threatening drops in blood pressure and breathing difficulties are possible with its use. ALK-Abellot will be distributing Odactra.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.