Allergy and Asthma Center Anita N. Wasan, MD, FAAP, FACAAI, FAAAAI 6824 Elm Street, Suite 120, Mclean, VA 22101

Tel: 703-992-7065 Fax: 703-992-7063

Informed Consent for Allergen Immunotherapy

Allergen immunotherapy (allergy shots) is used as a treatment for allergic rhinitis, asthma, allergic conjunctivitis, and insect allergy. It involves receiving injections with allergic extracts one to two times a week and gradually increasing the doses over time. The build-up phase usually lasts a few months, and then the maintenance phase is reached, in which you receive the most likely effective therapeutic dose. A more detailed explanation is provided in the handout on immunotherapy.

However, there are certain risks with allergen immunotherapy. One possible risk is an allergic reaction, which may include skin reactions, swelling, wheezing, shortness of breath, and nausea/vomiting. Allergic reactions can be fatal. Other side effects may include local reactions (swelling at injection site), bleeding, infections, and fainting or light-headedness. Treatment for reactions may involve the use of epinephrine (adrenaline) and additional supportive treatments.

I have reviewed the above, as well as the handout on allergen immunotherapy, and agree to undergo allergen immunotherapy. I understand the above, and all of my questions

Allergy Immunotherapy INFORMATION (Allergy Shots)

Allergy immunotherapy is indicated for allergy symptoms, including allergic rhinitis (i.e. sneezing, nasal congestion), allergic conjunctivitis (i.e. itchy, watery eyes), and/or allergic asthma. They are not indicated, at the current time, for chronic hives, food allergies, and/or eczema. Allergy injections should help decrease the intensity and/or frequency of your allergic symptoms and, hopefully, decrease the need for medications.

Once you decide to begin allergy shots, it takes about 7-14 days for us to prepare your allergy serum. The serum contains purified, sterile extracts of the allergens that correspond to both your allergy history and skin test results. The serum is then diluted to create vials of various strengths. You are started on the most dilute vial and then are gradually increased to your maintenance, or your strongest, vial. We will call you once your serum is ready and schedule an appointment for you to come in and receive your first allergy shot(s

Allergy immunotherapy is administered subcutaneously (injections) once or twice weekly (every 3-10 days) until the patient reaches maintenance. The dose is gradually increased each shot visit, provided that there are no adverse reactions. The build-up process can take up to 6-9 months, which can vary depending on the individual. Once the patient reaches maintenance, shots are gradually spaced out from every week to every two weeks, then every three weeks, and then eventually once a month. Improvement in allergy symptoms may be noted as early as 2 months in the buildup phase or as late as after the first year of therapy. In certain patients, allergy immunotherapy may not benefit your symptoms even after a year on allergy shots. If this is your situation, please be sure to discuss this with your allergist.

Since the serum is an allergenic substance, side effects can occur. Side effects of allergy immunotherapy include local reactions (redness and itchiness at the site of the injection) but they can also, although rare, lead to systemic reactions. Systemic reactions include diffuse hives, hausea/vomiting, lip/tongue swelling, difficulty breathing and/or swallowing, generalized flushing and/or itchiness, and/or dizziness. If these symptoms occur, usually epinephrine, antihistamines, and/or steroids can help counter these adverse reactions. The possibility of the systemic reaction is the main reason that we recommend that you wait for at least 30 minutes after your allergy injection at our office. You will also have been prescribed an EPI PEN to use as instructed and only if needed after you leave the office. Please bring your

epi pen with you when you come for your allergy shot. During the 30 minute wait, if you have any adverse

symptoms, please notify myself or one of my staff members IMMEDIATELY!

If you are on a medication of BETA BLOCKERS, please notify us BEFORE you receive your allergy shot. Also, if you had any problems with your last injection(s) including local redness/swelling at the shot site, please let us know BEFORE you receive your allergy shot. Please do NOT come for your allergy shot if you are having a fever, hives, difficulty breathing (i.e. persistent cough, wheezing, shortness of breath), and/or having nausea/vomiting. Please do NOT get your allergy shot on the same day that you have had another immunization (i.e. flu shot, tetanus shot Please notify our office if you are pregnant immediately.

Please do NOT exercise for at least one hour after receiving your allergy shot.

We schedule appointments for allergy shots. We will give you a time/day to get your weekly allergy shot when you are started on immunotherapy. We try our best to be accommodating to your busy schedule. If you are unable to come during your allotted appointment time, you will NOT be charged a cancellation fee. However, we would appreciate it if you could call us in advance. In addition, if you need to change your appointment during one week, please call us and we can try our best to arrange another time and day for your shot appt. If you are interested in getting your allergy shots at another physician's office or at an urgent care center, please contact our office and we can have this arranged. A physician must be present when you receive your allergy injections. All shot patients who are under the age of 18 years need to be accompanied by a parent/guardian in order to receive their allergy shot. You and/or your insurance company will be billed when the allergy serum is made. If you forget your appointments and your vials expire, new vials need to be made and you or your insurance company will be billed. Concentrate vials (red vials) are usually made up every 10-13 months as well.

Depending on the explanation of benefits we receive from your insurance company, you may have a shot copay at each shot visit. We will collect these copays before you get your shot. For more information on allergy shots, you may

visit the American Academy of Allergy, Asthma, and Immunology website at www.aaaai.org. If you have any questions, please contact our office at 703-992-7065.