Edward J. Sarti, MD Michael J. Katz, MD Sherif Hassan, MD Michael A Zozzaro, MD Cyrus Nozad, MD Otolaryngology, Head & Neck Surgery Otolaryngology, Head & Neck Surgery Otolaryngology, Head & Neck Surgery Otolaryngology, Head & Neck Surgery Allergy & Immunology www.NJFamilyENT.com 47 Orient Way Rutherford, NJ 07070 201-935-5508 6 Brighton Road Clifton, NJ 07012 973-470-0282 1265 Paterson Plank Road Secaucus, NJ 07094 201-864-4419 Immunotherapy Patient Consent Name: MRN: Purpose and Efficacy: The purpose of immunotherapy (allergy injections) is to decrease your sensitivity to allergy causing substances, so that exposure to the offending allergen (pollen, mold, mites, animal danders, stinging insects, etc.) will result in fewer and less severe symptoms. Improvement in your symptoms will not be immediate. It usually requires 3-6 months before any relief of allergy symptoms are noted and it may take 12-24 months for full benefits to be evident. About 80% or greater of allergic patients on immunotherapy note significant improvement of their symptoms. Allergy injections are begun at a very low dose. This dose is gradually increased approximately once per week until maintenance doses are reached. This takes approximately 9-12 months to achieve, but maybe longer. After the maintenance dose is reached, injections can be given every 3-4 weeks. It is recommended that patients on immunotherapy continue treatment for 3-5 years as this has been shown to cause longer term remission of symptoms. Of note, your dosing schedule may vary for various reasons e.g. missed doses. Local Reactions: Most patients receiving immunotherapy will sometimes have small areas of redness, swelling, and itch at the site of injection that produce little discomfort and are of no concern. These are to be distinguished from large, local reactions, 1 to 1.5 inches or greater in diameter which may cause considerable discomfort and persist for 24 hours or longer. Such reactions may be associated with either a systemic reaction or create concern that a further increase in dose may cause a systemic reaction (see below). After a large local reaction, the dose will be reduced to one that does not produce a significant degree of swelling. It is the responsibility of the patient and/or parent/guardian to inform the physician of any local reactions. In addition we ask that you refrain from strenuous exercise for 30 minutes before and 2 hours after the injection. Systemic reactions: The manifestations of systemic reactions range in severity and may include any of the following: nasal congestion, itchy eyes or throat, tightness in the throat, hives, swelling, flushing, wheezing, chest tightness, cough, lightheadedness, faintness, nausea, vomiting, diarrhea, headache, chills and stomach pain. Anaphylactic shock is the rarest complication, but is a serious event characterized by acute asthma, vascular collapse (low blood pressure) and potentially death. This reaction is extremely rare and usually occurs within minutes of the injection. For this reason it is recommended by the American Academy of Allergy and Immunology that there is a waiting period of at least 30 minutes after allergy injection in the doctor’s office. Some reactions may be delayed up to 6 hours after the injection. In the event of a severe reaction, like the ones described above, one should proceed immediately to an emergency treatment center/call EMS and call the physician even if the reaction stopped spontaneously. In addition an emergency care plan will be reviewed with you. It is important to write down on which arm the swelling occurred and that this information be conveyed to the doctor before your next injection. Pregnancy: Females of childbearing potential: If you become pregnant while on immunotherapy, notify the office staff immediately, so your physician can determine an appropriate dosage schedule for the injections during pregnancy. Immunotherapy doses will not be advanced during pregnancy, but may be maintained at a constant level. During the course of your treatment it is mandatory that you inform the doctor of any changes in medications or health status. Medications such as beta blockers may increase your risk of systemic reactions. I have read (if new patient) or reread (if established patient) the patient information sheet on immunotherapy and understand it. An opportunity has been provided for me to ask questions regarding the potential side effects of immunotherapy and all my 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 such reactions. My insurance will be billed for the allergy immunotherapy vaccine and I understand that I will be financially responsible for any balance remaining. Patient (or parent if patient is a minor) Date Witness Date