Informed Consent - Sublingual Immunotherapy

Sublingual immunotherapy (SLIT) is an allergy drop that is administered under the tongue.SLIT is safe to administer in the home setting but should be prescribed by a physician who is trained to treat any possible adverse reactions. For the first week or so, it is possible for you to experience minor itching or discomfort in the mouth or throat. These symptoms, should they occur, are typically brief and go away without any special treatment. Some individuals may experience mild abdominal discomfort in the first days of treatment.Occasional serious reactions have been reported that may require immediate treatment.These reactions may consist of any or all of the following symptoms: itchy eyes, nose, ears or throat; stuffy nose; sneezing; runny nose; mouth, nose or abdominal discomfort; coughing; swelling of the lips, tongue or throat; difficulty breathing; nausea and vomiting; hives; itching all over your body; and very rarely, a life-threatening systemic reaction known as anaphylaxis.Severe reactions, even though very unusual, may rarely occur at any time during the course of SLIT therapy. Because of the risk of a severe reaction, you agree to have self-injectable epinephrine on hand with each dose of SLIT therapy. Also, if you are 17 years of age or younger, a parent or legal guardian must be present for the administration and for the following 30 minutes.Sublingual immunotherapy is considered an off-label therapy. The formulation of sublingual immunotherapy is FDA approved although the route of administration is not. Subcutaneous immunotherapy is an FDA approved alternative but is not available from Curex.I have read (if new patient) or re-read (if established patient) the patient information sheet on sublingual immunotherapy and understand it. The opportunity has been provided for me to ask questions regarding the potential side effects of sublingual immunotherapy and these questions have been answered to my satisfaction. I understand that every precaution consistent with the best medical practice will be carried out to protect me against possible reactions associated with this treatment. I also agree that if I have an allergic reaction to the sublingual medication, I will follow the action plan I was given. I acknowledge that I am aware of the risks/benefits/alternatives to sublingual immunotherapy and consent/agree to starting this treatment. As the parent or legal guardian, I understand that I must be present with my child for every administration and for the entire 30-minute wait following administration.