Patient Name: «FirstName»«LastName»

MRN: «PatientAcccountNumer»
Date of Birth: «DOB»
Date of Service: «encDate»

CONSENT FOR ADMINISTRATION OF SPECIFIC ALLERGEN IMMUNOTHERAPY

(ALLERGY INJECTIONS)

PLEASE READ AND BE CERTAIN THAT YOU UNDERSTAND THE FOLLOWING

INFORMATION PRIOR TO SIGNING THIS CONSENT FOR TREATMENT

PURPOSE
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. This does not mean that immunotherapy is a substitute for avoidance of known allergens
or for the use of allergy medications, but rather is a supplement to those treatment measures.

Allergy injections have been shown to lead to the formation of “blocking” or protective antibodies and a gradual
decrease in allergic antibody levels. These changes may permit you to tolerate exposure to the allergen with fewer
symptoms.

INDICATIONS
To qualify for immunotherapy, there must be documented allergy to substances in the environment that are difficult to
be avoided. Documentation of allergy can be either in the form of a positive skin test or a positive blood test
(RAST/ELISA). In addition to demonstrable allergy by one of the above tests, problems such as hayfever or asthma
should occur upon exposure to the suspected allergen, or you may have a history of a severe reaction to an insect
sting. Due to the inherent risks of immunotherapy, avoidance measures and medical management should usually be
attempted first.

EFFICACY
Improvement in your symptoms will not be immediate. It usually requires 6 to 9 months before any relief of allergy
symptoms is noted, and it may take 12-24 months for full benefits to be evident. About 85-90% of allergic patients on
immunotherapy note significant improvement of their symptoms. This means that symptoms are reduced, although
not always completely eliminated.

PROCEDURE
Allergy injections are usually begun at a very low dose. This dosage is gradually increased on a regular basis until a
therapeutic dose (often called the “maintenance dose”) is reached. The maintenance dose will differ from person to
person. Injections typically are given once per week while the vaccine dose is being increased. This frequency
reduces the chances of a reaction and permits the maintenance dose to be reached within a reasonable amount of
time. After the maintenance dose is determined, the injections can usually be given monthly.

DURATION OF TREATMENT
It usually takes 3 to 6 months to reach a maintenance dose. The time may be longer if there are vaccine reactions or
if the injections are not received on a regular basis. For this reason, it is important that the recommended schedule
be followed. If you anticipate that regular injections cannot be maintained, immunotherapy should not be started.
Immunotherapy may be discontinued at the discretion of our physicians if the injections are frequently missed, as
there is an increased risk of reactions under these circumstances. Most immunotherapy patients continue treatment
for 3-5 years, after which the need for continuation is reassessed.

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ADVERSE REACTIONS
Immunotherapy is associated with some widely recognized risks. Risk is present because a substance to which you
are known to be allergic is being injected into you. Some adverse reactions may be life-threatening and may require
immediate medical attention. In order of increasing severity, the following brief descriptions explain the nature of
these potential reactions:

A. LOCAL REACTIONS:
Local reactions are common and are usually restricted to a small area around the site of the injection. However, they
may involve the entire upper arm, with varying degrees of redness, swelling, pain, and itching. These reactions are
more likely to occur as you reach the higher concentrations and higher volume injections. The reactions may occur
several hours after the injection. You should notify our staff if your local reaction exceeds two inches in diameter or
lasts until the following day.

B. GENERALIZED REACTIONS:
Generalized reactions occur rarely, but are the most important because of the potential danger of progression to
collapse and death if not treated. These reactions may include:
(1) Urticarial reactions (hives) include varying degrees of rash, swelling, and/or itching of more than one part of
the body. There may be mild to moderate discomfort, primarily from the itching. This uncommon reaction may occur
within minutes to hours after an injection.
(2) Angioedema is rare and is characterized by swelling of any part of the body, inside or out, such as the ears,
tongue, lips, throat, intestine, hands, or feet, alone or in any combination. This may occasionally be accompanied by
asthma and may progress to the most severe reaction, anaphylactic shock. In the absence of shock, the principle
danger lies in suffocation due to swelling of the airway. Angioedema may occur within minutes after the injection and
requires immediate medical attention.
(3) Anaphylactic shock is the rarest complication, but is a serious event characterized by acute asthma, vascular
collapse (low blood pressure), unconsciousness, and potentially death. This reaction usually occurs within minutes of
the injection and is extremely rare.

The above reactions are unpredictable and may occur with the first injection or after a long series of injections, with
no previous warning. All generalized reactions require immediate evaluation and medical intervention. If a localized or
generalized reaction occurs, the vaccine dosage will be adjusted for subsequent injections. Appropriate advice and
treatment will always be available from our office staff at the time of any adverse reaction.

OBSERVATION PERIOD FOLLOWING INJECTIONS

All patients receiving immunotherapy injections should wait in the clinic area for 30 minutes following each
injection. If you have a reaction, you may be advised to remain in the clinic longer for medical observation and
treatment. If a generalized reaction occurs after you have left the clinic area, you should immediately return to the
clinic or go to the nearest emergency medical facility. If you cannot wait the 30 minutes after your injection, you
should not receive an immunotherapy injection. There are several allergy vaccine-related deaths each year in the
United States. While most systemic reactions are not life-threatening if treated promptly, this fact does stress the
importance of remaining in the clinic for the suggested observation time. If you do not remain in the clinic area for the
designated time, the doctor may recommend discontinuation of immunotherapy.

Under no circumstances will injections be permitted without the immediate availability of emergency medical
treatment. If the prescribed injections are to be given elsewhere, this clinic must be provided with the name and
address of the physician who will assume the responsibility for your injections. You will be asked to complete the
“Request for Administration of Immunotherapy at an Outside Medical Facility.” Our office will then contact the
designated facility and confirm their availability for administration of the immunotherapy injections.

INITIAL EXTRACT PRESCRIPTION

Your initial prescription includes all vaccine vials that are required to reach a “maintenance” dose. In order to utilize
these vials prior to their expiration date, you will need to receive injections at least once per week on a regular basis.
Taking injections twice per week will allow you to reach maintenance earlier, well before expiration. If you take
injections once per week regularly, you will reach maintenance level at about the same time as the expiration date.
When you receive regular maintenance injections, the renewal vials generally last 2 to 3 months, but still carry a 6-
month expiration period.
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PREGNANCY
Females of childbearing potential: If you become pregnant while on immunotherapy, notify the office staff
immediately, so that our physicians 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.

NEW MEDICATIONS
Please notify the office staff if you start any new prescription medication, particularly medication for high blood
pressure, migraine headaches, and glaucoma. “Beta blocker” medications are contraindicated while on
immunotherapy.

ATTACHMENTS

If you have questions concerning anything in this Consent for Immunotherapy, please direct the questions to our staff.
If you wish to begin immunotherapy, please initial and date each of the first three pages of this document, then sign
the Authorization for Treatment (below) in the presence of a witness and return it to our front desk. Thank you.

CONSENT FOR ADMINISTRATION OF IMMUNOTHERAPY (ALLERGY INJECTIONS)

AUTHORIZATION FOR TREATMENT

I have read the information in this consent form and understand it. The opportunity has been provided for me to ask
questions regarding the potential risks of immunotherapy, and these questions have been answered to my
satisfaction. I understand that precautions consistent with the best medical practice will be carried out to protect me
from adverse reactions to immunotherapy. I do hereby give consent for the patient designated below to be given
immunotherapy (allergy injections) over an extended period of time and at specified intervals, as prescribed. I
further hereby give authorization and consent for treatment of any reactions that may occur as a result of an
immunotherapy injection.

Printed Name of Immunotherapy Patient Medical Record Number

_____________________________________ ____________________

Patient Signature (or Legal Guardian) Date Signed

_____________________________________ ____________________

Witness Date Signed

FOR OFFICE USE ONLY:

I certify that I have counseled this patient and/or authorized legal guardian concerning the information in this
Consent for Immunotherapy and that it appears to me that the signee understands the nature, risks, and
benefits of the proposed treatment plan.

_____________________________________ ____________________
Date Signed

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Boston Food Allergy Center

Immunotherapy info sheet

Allergen immunotherapy injections

Also known as “allergy shots” are prescribed for patients with allergic rhinitis (hay fever),
allergic asthma or life threatening reactions to insect stings. Immunotherapy is the only
medical treatment that could potentially modify allergic disease. Some studies have shown
that it may have a preventive role in allergic children, possibly preventing asthma from
developing in some patients with allergic rhinitis. Immunotherapy would be considered for
individuals who have moderate or severe symptoms not adequately controlled by
environmental control measures and/or medications.

Effectiveness
Allergen immunotherapy (Allergy shots) may “turn down” allergic reactions to common
allergens including pollens, molds, animal dander and dust mites. In most cases, the initial 6
to 12 month course of allergy shots is likely to gradually decrease sensitivity to airborne
allergens and continuation of injections leads to further improvement. The injections do not
cure patients but diminish sensitivities, resulting in fewer symptoms and use of fewer
medications. It is important to maintain shots at the proper time interval; missing your shots
for a short time may be acceptable but an appropriate adjustment in the dose of vaccine
may be necessary for long lapses in injections.

The Benefits of Immunotherapy

Relief of allergy symptoms can be appreciated early in the build-up phase but may take as
long as one year on maintenance. Failure to respond after one year on maintenance therapy
warrants further evaluation and possibly discontinuation of treatment. Successful
maintenance treatment is generally continued for 3 to 5 years. The decision to stop
immunotherapy will be discussed after 3 to 5 years of treatment. Some people may
experience lasting remission of their allergy symptoms after discontinuing treatment. Others
may relapse after discontinuing immunotherapy, some will have a slight increase in
symptoms controllable with medications, and others may require resumption of allergy
injections in time. You will be re-evaluated periodically while on injections; changes in the
allergen vaccine or injection schedule may be necessary to obtain optimal results. Once a
year a serum review will be done during a visit with the provider to evaluate making a new
serum for the following year. Serums must be remade every year.

Beta-blockers and Immunotherapy

Beta-blockers are contraindicated while on immunotherapy. Beta-blockers are medications
typically used for, but not limited to, heart conditions or migraines/headaches. If you are
taking a beta-blocker or are unsure if you are, please discuss this with your provider. To
ensure your safety before starting allergy injections, we would be happy to review your list
of medications with you. Please inform us if you start on a new medication.
 Patient Name: «FirstName»«LastName»
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Allergy Injection Build-up and Maintenance Schedule

When you are starting injections for the first time there are two ways that you can begin: the
traditional build up or cluster immunotherapy (shots). In order to cluster, your Provider must
give his or her consent, and they will discuss this with you if they think you are a candidate.
After the initial build up phase you will begin the maintenance phase. Below is a typical
allergy shot schedule (it may vary for individual patient):

Traditional build-up: In traditional build up, you can come once or twice a week. When you
have reached the top dose you will go every other week for two weeks then maintain at
once every 3-4 weeks. Most patients are on shots for 3-5 years.

Cluster build-up: This is a more advanced schedule. Each time you come in we will
increase the dose multiple times at 30 minute increments. Cluster build up has been shown
to be safe and effective.

Maintenance phase: This phase begins when the effective therapeutic dose is reached.
The effective therapeutic dose is based on recommendations from a national collaborative
committee called the Joint Task Force for Practice Parameters: Allergen
Immunotherapy: A Practice Parameter and was determined after review of a number of
published studies on immunotherapy. The effective maintenance dose may be individualized
for a particular person based on their degree of sensitivity (how “allergic they are” to the
allergens in their vaccine) and their response to the immunotherapy buildup phase. Once
the target maintenance dose is reached, the intervals between the allergy injections can be
increased. The intervals between maintenance immunotherapy injections generally ranges
from every 2 to every 4 weeks but should be individualized to provide the best combination
of effectiveness and safety for each person. Shorter intervals between allergy injections may
lead to fewer reaction and greater benefit in some people.

Reactions to allergy injections

It is possible to have an allergic reaction to the allergy injection itself. Reactions can be local,
which are common (swelling at the injection site) or systemic (affecting the rest of the
body). Systemic reactions occurring in 7-10% of injection patients include hay fever type
symptoms, hives, flushing, lightheadedness, and/or asthma, and rarely, life threatening
reactions. Fatal reactions are rare but have been reported in 1 to 2 million injections. Some
conditions can make allergic reactions to the injections more likely: heavy natural exposure
to pollen during a pollen season and exercise after an injection. Serious systemic reaction
can occur in patients with asthma that has worsened and is not well controlled on
recommended medications. Therefore, if you have noted worsening of your asthma
symptoms, notify your nurse or physician before receiving your scheduled injections!
Reactions to injections can occur, however, even in the absence of these conditions.

1. If any symptoms occur immediately or within hours of your injection, please

inform the nurse before you receive your next injection.
2. Patient must wait for 30 minutes after receiving an allergy injection(s) in the
doctor’s office staffed with appropriate medical personal.
3. Patient should not exercise for 4-6 hours after the injection.
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4. Patient should have epinephrine on their person and at school/work in case

of an anaphylactic reaction after receiving the allergy injections.
5. To minimize reactions to allergy shots, the providers recommend that the
patient take an antihistamine within 24 hours before receiving the shots.
6. Please inform the nursing staff if you have been diagnosed with a new
medical condition or prescribed any new medications since your last visit. If
any symptoms occur immediately or within hours of your injection, please
inform the nurse before you receive your next injection.
7. Please inform the nursing staff if you have asthma exacerbation prior to the
allergy shots or recent illness. We might need to put the allergy shots on hold
IMPORTANT FINANCIAL CONSIDERATION

Immunotherapy is expensive. Having said that, it is usually covered by your insurance as it is a

“standard of care”. However, it is prudent to call your insurance to make sure. When you call
your insurance, tell them the following “CPT codes” will be used for immunotherapy: 95165
(antigen preparation) and 95117 (immunotherapy shots). Ask if you have a “deductible” and if you
have a “copay” associated with each visit for injection. If you chose to have “cluster
immunotherapy”, you need to confirm with your insurance that CPT 95180 will be covered.
for safety reasons.