IMMUNOTHERAPY CONSENT FORM for Patient: _________________________________ Immunotherapy, or allergy shots, is a form of treatment for allergic rhinitis, stinging insect allergy, allergic asthma, and occasionally atopic dermatitis. When these injections are repeated, the body’s immune system learns to tolerate the allergen. Many carefully performed studies have shown that immunotherapy decreases allergic symptoms. In children, it has also been shown to significantly reduce the likelihood of developing new allergies or being diagnosed with asthma. Who should be treated with immunotherapy? First, the patient must have an allergic problem. Second, the patient must have a test to determine the relevant allergens. This is most reliably determined by a skin prick test. Third, there should be a correlation between exposure to the relevant allergens and the allergy symptoms. However, detailed testing of this correlation is not always practical. Each patient should also consider the alternatives, such as the possibility of avoiding the offending allergens. There are also medicines that are safe and effective for allergic problems. Immunotherapy might make more sense for the patient who hopes to avoid taking allergy medications for the rest of his life, or if the medications are inadequate to treat the symptoms. For those adults who are allergic to insect stings, and have suffered a systemic reaction (also called anaphylaxis), immunotherapy is recommended to reduce your risk for anaphylaxis or death. How is immunotherapy administered? Immunotherapy is the process of injecting a person with the allergens to which he or she is allergic. It works best when the allergens are injected under the skin. To start with a high dose would be unsafe. Therefore, we make several dilutions, and start with a concentration that is 1/1000 of the maintenance concentration. We also start with a very small volume (0.05ml), and over numerous doses, we increase the dose volume, and then repeat the process for increasing concentrations. For common allergens, this series includes 26 injections to reach full maintenance dose. During this buildup phase, we recommend getting at least one injection per week. After the maintenance dose is achieved, we can evaluate whether to space out the injections to every 2, 3, or 4 weeks. It is also possible to do immunotherapy as drops under the tongue, which is called sublingual immunotherapy (SLIT). This has been done for many years in Europe, and a lot of data is available on the effectiveness of SLIT, but no allergy extract products have received FDA labeling for delivery under the tongue. Therefore, some insurance companies, Medicare in particular, specifically will not pay for SLIT. SLIT does not require the extensive build-up procedure, and severe reactions are rare. However, it must be taken at least twice per day to be most effective. Even then, studies show it to be somewhat less effective that the shots given under the skin, and the ideal dose is still being studied. How long should a patient be treated with immunotherapy? Traditionally, patients are treated for three to five years. There are well controlled studies which show that the benefit of immunotherapy persists for several years after the shots are completed. For example, after four years of immunotherapy shots, one can expect to do just as well after the shots are stopped for another four years. After that, symptoms tend to slowly get worse. It may take decades before the symptoms are as severe as before immunotherapy was started. However, the long-term benefit is not guaranteed. Some people find that symptoms return shortly after discontinuing their shots. In this case, we can restart the shots if desired. What are the risks associated with the immunotherapy? The risks fall into two broad categories: local reactions, and systemic or generalized reactions (also referred to as anaphylaxis). Either of these categories may occur with any dose, even after you have been on shots for years at a constant dose.
Local reactions generally consist of itching and swelling at the injection site. The reaction size may be smaller than a dime, or larger than half of a large lemon. They require no medical treatment, but if large, the dose is generally reduced for the next shot. For patients who would use sublingual immunotherapy, the local reactions would involve the tongue, mouth, uvula, or throat. Generalized reactions can be much more concerning. They can be mild, such as a mild worsening of your nasal allergy symptoms, or a mild worsening of your asthma. They can be severe, in which case we generally use the term anaphylaxis. Symptoms may include hives (whelps) over some or all of the body, a drop in blood pressure, swelling (typically of the eyes, lips, tongue, or throat), or a severe asthma attack. Someone with anaphylaxis may have to lie down to avoid passing out. In severe cases that are not treated promptly, it may be fatal. Statistically, this occurs approximately once for every 2 million allergy shots given in the United States. This translates to a risk of 0.000 000 50 per shot. What can be done to minimize the risk? First, approximately 90% of serious reactions occur within the first 15 to 20 minutes after the shot. If anaphylaxis occurs, the treatment is a prompt dose of epinephrine; it may need to be repeated. Even a 10 minute delay reduces how well the epinephrine works. Therefore, we ask every patient to stay for 20 minutes after every injection. In addition, we recommend you keep an EpiPen with you during and after your immunotherapy shots. If you have symptoms of anaphylaxis, USE YOUR EPIPEN IMMEDIATELY, then dial 911 for an ambulance to take you to an ER. A second dose of Epinephrine may be taken if needed, after 5 to 15 minutes. Because epinephrine is so important in the treatment of anaphylaxis, we want our allergy patients to avoid taking any medication that blocks epinephrine, specifically a family of blood pressure medications known as “beta-blockers.” The generic name of each of these beta blockers ends in the letters “olol”, such as metoprolol or atenolol. If you take one of these beta blockers, it is considered a relative contraindication to getting immunotherapy shots. However, there are people desperate for the benefits of immunotherapy shots, but we need to discuss this extra risk for these cases. Although a serious reaction can happen with any dose, there are times of greater than average risk. These include: 1) when there are increased levels of the allergens to which you are allergic, 2) when allergy or asthma symptoms are more severe, 3) when the dose is being increased, 4) with the first dose from a new vial, 5) if you have had a previous episode of anaphylaxis from an allergy shot. To minimize these risks, we ask that you let us know if you have been sick, or your allergy or asthma symptoms are worse. It has been shown that an oral antihistamine reduces the risk of reactions, so I recommend taking an antihistamine before each shot. If you need assistance controlling your allergies or asthma, please let us know. By signing below, I indicate that I have read this explanation, and accept the risks of immunotherapy for myself or for my child.
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