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What is ODACTRA?
ODACTRA is a prescription medicine used for sublingual (under the tongue) immunotherapy to treat house dust mite allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. ODACTRA may be prescribed for persons 18 through 65 years of age who are allergic to house dust mites. ODACTRA is NOT a medication that gives immediate relief for symptoms of house dust mite allergy.
Selected Important Safety
Information about ODACTRA
What is the most important information I should know about ODACTRA?
ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking ODACTRA and immediately seek medical care:
For home administration of ODACTRA, your doctor should prescribe auto-injectable epinephrine to treat a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine.
If you forget to take ODACTRA, do not take two tablets. Take the next tablet at your normal scheduled time the next day. If you miss more than one tablet of ODACTRA, contact your doctor before restarting.
Do not take ODACTRA if:
Your doctor may decide that ODACTRA is not the best treatment if:
Stop taking ODACTRA and contact your doctor if you have any mouth surgery procedures (such as tooth removal), develop any mouth infections, ulcers or cuts in the mouth or throat, or have heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens.
The most commonly reported side effects were throat irritation/tickle, itching in the mouth or ears, swelling of the back of the mouth, lips or tongue. These side effects, by themselves, are generally not dangerous or life-threatening.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.