Sublingual Immunotherapy (SLIT) Informed Consent

What is Sublingual Immunotherapy (SLIT)?

Sublingual Immunotherapy (SLIT), also known as Oral Immunotherapy or Allergy Drops, is an

alternative to allergy shots and involves placing drops of allergen extracts under your tongue. The

purpose of this treatment is to decrease your sensitivity to airborne allergens (pollens, pets, dust

mites, etc.) so that when you are exposed to these allergens, you will experience fewer or no allergic

symptoms. These are the same extracts used for allergy shots, but are given daily under the tongue.

Who qualifies for SLIT?

You must have documented allergies by skin or blood test to airborne allergies with nasal or

asthma symptoms due to these allergens. Both children and adults are candidates for SLIT.

Who does not qualify for SLIT?

You are at increased risk of a systemic reaction if you have poorly controlled asthma. Therefore,

you should not start SLIT until your asthma is under good control. Pregnant women may continue

SLIT, but should not start this treatment during pregnancy. SLIT may be contraindicated in people

who take medications called beta-blockers, which are often used for high blood pressure, migraine

headaches, or glaucoma. Avoid if you have eosinophilic esophagitis or if you have open sores in

your mouth. You should inform your allergy provider if you become pregnant or if there is

significant change in your medical condition.

How does it work?

Like allergy shots, SLIT slowly alters your immune system’s response to allergens by inducing

tolerance or immunity to the allergens in the drops. If effective, you should have fewer or no

symptoms upon exposure to the allergens that trigger your symptoms.

How is it administered?

Allergen extract drops will be placed under your tongue for 2 minutes, and then swallowed. The

first dose will be administered in the office and you will be observed for 30 minutes. You will

continue advancing doses at home.

How effective is it?

Most clinical studies have shown improvement in symptoms and a decrease in need for medication

in patients on SLIT. Adjustments can be made to your treatment extracts to achieve the maximum

effectiveness. To determine if SLIT is effective for you, you should plan on taking the drops for at

least one year and have regular follow ups with your allergy provider. Most experts recommend a

3-5 year course of treatment to get long-term benefits that extend beyond the treatment period.

Will I still need to take allergy medication?

During the initial months you may need to take the same medications as before. As the treatment

begins to take effect, you will discuss decreasing the allergy medications with your allergy provider

at your regular follow-up visits.

What are the side effects?

Mild side effects are common and include itching lips or mouth within minutes to hours of the dose.

This can occur in up to 1/3 of patients, usually in the first 2 weeks of therapy and then goes away as

therapy continues. These reactions may be treated with an oral antihistamine. We recommend

taking a daily antihistamine for the first several weeks of SLIT to prevent these symptoms until you

tolerate your maintenance dose. Moderate side effects occur rarely and can include:

• Lip swelling

• Eye itching, redness and swelling

• Sneezing, nasal itching, nasal congestion

• Hives, swelling

• Nausea, vomiting, abdominal cramping, diarrhea

• Asthma symptoms: cough, wheeze, shortness of breath

Severe side effects, such as a drop in blood pressure, are extremely uncommon and no fatalities

have been reported from this form of treatment. For this reason, unlike allergy shots, we allow

patients to take drops at home. However, all patients should be aware of allergic reactions and may

choose to have injectable epinephrine available in case of a severe reaction (in Europe, epinephrine

is not routinely provided. In the United States, it is more commonly provided. We recommend an

epinephrine autoinjector, at least when you first start). If you have moderate or severe reactions

you must contact the office and stop the treatment until you have met and discussed these reactions

with your allergy provider.

Another rare, delayed reaction to SLIT is eosinophilic esophagitis. Basically, your esophagus gets a

rash from swallowing the drops. Symptoms consist of heartburn or difficulty swallowing.

Symptoms are not permanent and resolve with discontinuation of SLIT.

Is SLIT safe during pregnancy and nursing?

There is not data available on the safety of administering sublingual immunotherapy during

pregnancy or nursing. It is important that women, who are on SLIT and know or believe they are

pregnant, notify their allergy provider as soon as possible.

Is SLIT approved by the FDA?

No. While SLIT is the more common method of treatment of allergic diseases than allergy shots in

Europe, and is gaining popularity in the U.S., at present, it is yet not approved by the FDA. .

Therefore, it is still considered an investigational treatment and an off-label use of allergy extracts.

Tablets containing grass, ragweed or dust mites that work thought the same mechanism as SLIT,

are FDA approved but will only treat one allergen at a time.

What does it cost? Will insurance cover SLIT?

Until the FDA approves SLIT, most insurance companies will not pay for the treatment itself. Out-of-

pocket cost involves the preparation of each allergy solution, which will contain allergens to which

you are allergic.

How does SLIT compare with traditional Allergy Shots?

While comparative studies are limited, both therapies provide clinical improvement. But most

experts agree that traditional allergy shots appear slightly more effective than SLIT. However, SLIT

appears to be safer. Therefore, a major benefit of SLIT is that the drops may be administered at

home, as opposed to injections administered in a doctor’s office. As a result, there is significant

time and travel savings. There is also the savings of a co-payment for allergy injections.

What are the alternatives to SLIT?

Standard treatments for allergies include: allergy avoidance, medications, dissolving tablets, and

traditional allergy shots. You should discuss these alternatives with your allergy provider.

What if I have additional questions?

You should feel free to contact your allergy provider with any further questions or concerns about

SLIT.

Consent for Administration of Sublingual Immunotherapy (SLIT)

I have read the information in this consent form and understand it. I was given the opportunity to

ask questions regarding the potential risks of SLIT and these questions have been answered to my

satisfaction. I give consent for the patient designated below to be given allergen SLIT. I am aware

that I am financially responsible for the patient-specific allergy solution prepared. Payment is

expected before vials are prepared for you.

____________________________________________ __________________________________________

Patient Name (Print)/DOB Patient or Parent/Guardian Signature

____________________________________________ __________________________________________

Witness Date

Copy of signed form given to patient _____________

Staff initials