TRAININGMANUAL

Allergy Testing &Treatment Program

provided by

Revergence Healthcare, LLC, © Copyright 2015 All Rights Reserved

CONTENTSALLERGY SYMPTOMS 1

Page

METHODOLOGY 2

ALLERGIC THRESHOLD 3

PATIENT CASE 4

THE SCIENCE BEHIND THE ALLERGY TEST 5

SCHEDULING A PATIENT FOR ALLERGY TEST 6

PREPARATION OF MULTI-TEST II DIP-WELL TRAY 8

CLINICAL STAFF INFORMATION 7

ABOUT THE ALLERGY TEST 10

ALLERGY TEST PROCEDURE 12

MEDICATIONS THAT INTERFERE WITH ALLERGY TESTING 11

BILLING & CODING OVERVIEW 14

SUBLINGUAL IMMUNOTHERAPY 18

HOW TO ADMINISTER DROPS

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SUBLINGUAL VS. SUBCUTANEOUS IMMUNOTHERAPY 20

ANAPHYLAXIS 21

The Revergence Healthcare team, including licensed pharmacists and our knowledgeable customer service staff, are here to help you and your patients every step of the way. This Clinician’s Manual is your guide to identifying and treating your patients’ allergies with the state-of-the-art Revergence Healthcare allergy immunotherapy.

Fifty-six percent (56%) of Americans are allergic to more than two allergens; WHAT ARE THEY? The Revergence Healthcare Allergy Test provides clinicians a way to identify which allergens are causing a patient’s allergy symptoms. Once the patient’s allergies are identified, our revolutionary Allergy Drops slowly and safely build the patient’s tolerance to those allergens. An annual follow up Allergy Test will be used to show the decrease in the number and severity of the patient’s allergies.

Head, Ears, Eyes, Nose, Throat: Malaise & Fatigue Migraine Acute Allergic Conjunctivitis Acute Allergic Otitis Media Chronic Rhinitis Allergic Rhinitis Pollen Rhinitis Nasal Polyps Postnasal Drip Streptococcal Sore Throat Tonsil & Adenoid Hypertrophy

Upper Respiratory: Asthma Bronchitis Cough URI Acute Pneumonia Sinusitis Laryngitis Wheezing Abnormal Chest Sounds

Gastrointestinal: Allergic Gastroenteritis Celiac Persistent Vomiting Diarrhea

Skin: Atopic Dermatitis Contact Dermatitis Dermatitis, Food Dermatitis, Medication Diaper Dermatitis Plant Contact Allergic Urticaria Dermatographic Urticaria

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Do Your Patients Suffer From Any of these Symptoms?

All symptoms listed above could be caused by allergies!

METHODOLOGY

Evidence-BasedAllergy Treatment

Symptom-BasedAllergy Treatment

There is now an optimal method to test and treat your patients’ allergy symptoms with evidence-based protocols. This test allows you and your patients to appropriately identify the allergens causing the patient’s symptoms. The treatment helps to desensitize and manage the allergies, and ultimately obtain success by building up the patient’s tolerance.

“[Immunotherapy] is the only known treatment that modifies the immune response and treats the cause rather than the symptoms”

- The Cochrane Library: Sublingual immunotherapy for Allergic Rhinitis 2010

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The Allergic Threshold chart above shows the “Cumulative Effect” of allergens. In the first column, the patient may be exposed to two (2) different allergens and show no symptoms. Once this patient is exposed to a third allergen, the allergic threshold is crossed resulting in patient displayed allergy symptoms. Does this mean the patient is only allergic to number 3? The answer is No. The patient is allergic to Allergen 1, 2, and 3. The cumulative effect of the three allergens together caused the patient’s symptoms to surface. By performing the Revergence Allergy Test, you will be able to identify which allergens are the cause of the patient’s symptoms.

The last two columns in the chart reflect how Revergence can help your patients. Once the allergens causing symptoms are identified by a Revergence Allergy Test, the patient can be educated on which allergens to avoid. However, not all allergens can be avoided. This is where Revergence Allergy Drops can help! Allergy immunotherapy can “desensitize” allergic response to specific allergens, therefore increasing their Allergic Threshold. An increased Allergic Threshold will relieve the patient of allergy symptoms.

ALLERGIC THRESHOLDThe Cumulative Effect

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A 51 year old male presents with severe life-long allergies. He has had multiple sinus surgeries/polyps removed, as well as life-long skin rashes, eczema, migraine headaches, and suffers from asthma. The patient originally tested positive for 50 allergens on 6/25/08. After 12 months of using sublingual therapy and utilizing the same testing, the patient tested positive for 6 allergens (with decreased reactions to all additional allergens tested).

Patient Comment: “I noticed a reduction in my symptoms within the first 30-45 days. At 60 days, my red skin returned to normal and after 180 days, my eczema was completely gone! I would have 3-4 sinus infections every year and since the drops, I haven’t even had a stuffy nose! I have NEVER had anything ever work like this!”

PATIENT CASE

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6/25/08 Allergen Test

6/26/09 Allergen Follow-up Test

Once the allergens are introduced to the skin, it spreads through the skin where it may bind to IgE antibodies attached to mast cells.

Mast cells will then release mediators known as histamine.

The wheal response (raised bump) is due to the histamine entering a blood vessel (vasopermeability) and causing secondary swelling (edema).

The flare response (redness of the skin-erythema) is the result of congestion of the capillaries in the lower layers of the skin.

Wheals and flares typically peak 15 to 20 minutes after the introduction of allergens.

The Science Behind the Allergy Test

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INSURANCEOnce the physician orders allergy testing, verification of benefits for allergy testing and immunotherapy must be completed prior to performing the test. There are many insurance plans that allow coverage for allergy testing. It is important that you obtain the specific information related to how often the testing is allowed, accepted number of allergens allowed, and insurance carrier requirements for authorizing testing and immunotherapy treatment. If Allergy Testing and Immunotherapy is covered and authorized by the insurance carrier, office staff can obtain the estimated out-of-pocket costs by verifying the following with the insurance carrier:

Scheduling a Patient for Allergy Testing

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SCHEDULINGPrior to scheduling Allergy Testing, ensure the physician’s order is documented in the patient’s medical records. Testing must be performed when a provider is in the office. Once testing is scheduled, provide the patient with the Testing packet, which includes patient instructions, patient education material, and consent form.

It is important that patients obtain and review the information (i.e. patient instructions, consent forms, insurance coverage, medication avoidance, treatment options) prior to testing. If you choose to provide the Testing immediately after the order, please ensure you review the patient packet with them and verify current medications. Ensure patient completes allergy history form to be included in their medical record. Proper consent must be obtained from the patient acknowledging he/she understands the instructions, consents to treatment, and financial responsibility.

Inform the patient that insurance will be verified for coverage prior to the service. The office will notify the patient of all expected out-of-pocket costs and benefits during the reminder call.

Verify the patient’s insurance is active for the service date. Verify and confirm if the testing and immunotherapy is covered by the in-office co-payment, applied to the patient’s deductible, or covered by the patient’s co-insurance.

If applied to the patient’s deductible, verify the deductible amount remaining so the office can properly calculate the patient’s costs by utilizing the contractual allowed amount for services. If the patient has met his/her deductible, then calculate the proper co-insurance (percentage) the patient will be responsible to pay. **Remember: this is an estimate and does not guarantee payment.**

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Your doctor or provider has determined that skin testing of common inhaled allergens (allergic triggers) will be helpful in treatment of the patient’s sinus, nasal, throat or ear symptoms. Tree, grass, and weed pollens common to your region will be tested in addition to a wide variety of mold spores, and household irritants like dust, dust mites, and pet dander. Certain food sensitivities are evaluated as well.

CLINICAL STAFF INFORMATION

Testing allows determination of how likely it is that inhaled allergens play a role in your patient’s symptoms. Some conditions like non-allergic rhinitis, infection or gastric reflux may produce symptoms identical to allergic rhinitis and can be difficult to distinguish without testing. Another important reason for testing is identification of specific allergic triggers. Identifying triggers is critical for serious allergy sufferers since one of the keys to effective treatment is AVOIDANCE. Testing is also the first step in formulating an alternative therapy to traditional allergy medications called immunotherapy, which may offer effective long-term suppression of allergic disease.

WHY TEST FOR ALLERGIES

Skin testing is done very easily and without pricking the skin. The skin test involves placing a multi-test applicator with several test sites applied to the patient’s back at once. The device has no needles and does not break the skin. A total of seventy (70) allergens are placed on the skin, as well as a small amount of histamine to make sure your skin is capable of producing a normal, visible skin reaction. Skin reactions are measured after twenty (20) minutes. Itching, redness and wheals (small, itchy lumps) indicate sensitivity to a particular allergen or a normal response to histamine. If no response is seen to histamine, the test cannot be interpreted and must be rescheduled. The most common reason for lack of histamine response is use of antihistamines or medications that block the normal histamine response. Patients will be provided a list of medications that may interfere with testing. Be sure to question patients regarding their consumption of those medications.

HOW IS SKIN TESTING PERFORMED?

Skin testing is not painful and usually well tolerated other than itching and redness. A soothing cream is provided to assist patient comfort after the test. Occasionally, large responses may take a few hours to clear. Rarely, they may take a couple of days to clear. The patient must notify you if a delayed reaction occurs (a wheal develops after 2-3 days where one was not seen before). Wheezing, cough, and flaring of allergy symptoms are possible with testing, especially if large skin reactions were seen. Patients that are taking Beta-blockers or are asthmatics are more likely to have these severe reactions.

AFTER THE TEST

Patients taking beta-blockers (Toprol, Metoprolol, Inderal, Atenolol) to control high blood pressure or for a heart condition or patients having asthma that is difficult to control (frequent wheezing, shortness of breath, or frequent inhaler usage) should have testing completed PRIOR to taking the daily dose of these medications. Patients SHOULD NOT take these medications at home. Patients should be instructed to bring them and take immediately following his/her allergy skin test.

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Preparation of Multi-Test II Dip-well tray

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SUPPLIESProvided by Revergence Healthcare

CartTimers (x3)Gauze holderWaste CanAllergy Test Report FormOther Allergy Testing Patient FormsAllergen extract dropper bottlesMulti-Test II Dip-well trays with lids and labels (3)Multi-Test II Sterile Disposable Applicators (567)Anti-Itch Cream

Provided by Physician’s OfficeSharps ContainerBio Red bagBio StickersGauze PadsAlcoholGloves and Face maskEpi-PensSkin Pens

STEPS

NOTE: Each well must contain enough volume, at all times, to allow for complete submersion of the test heads on the Multi-Test II sterile applicator.

Using the dropper bottles containing allergenic extract, dispense approximately half or .5ml of extract into the properly identified and numbered well according to the lid label.

Remove the lid from the tray without touching the inside of the lid or the top surface of the tray.

Perform hand washing and don cap, face mask, gown and sterile gloves according to USP 797 guidelines. (refer to chapter 6 of USP 797 Guidelines, www.usp.org)

Identify and mark each set of 8 wells pictured on the lid label as “Battery A, B, C, etc.” by writing the letters in the appropriate spaces on the clear tray.

Remove the tray carefully from the package, keeping the lid over the dipwells until they are ready to be filled with allergen extracts.

Clean work area with alcohol according to aseptic USP 797 guidelines and gather the above specified supplies. (refer to chapter 6 of USP 797 Guidelines, www.usp.org)

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It is important that all the supplies are accessible before and during the test. Do not start the test without all the supplies

listed above.

***IMPORTANT NOTE***

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Preparation of Multi-Test II Dip-well traycontinued...

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Store the covered trays in the designated medication/biohazard refrigerator at 2 - 8 C (35.6º - 46.4º F)

Label the trays with the preparation and expiration date. (Expiration date of the tray will be the same as the shortest dated allergenic extract in the tray) Trays may be refilled when wells run low as long as the tray is clean and not contaminated. Check for drips of antigen on the surface of the tray - if the tray appears contaminated, replace tray with a new one.

Place the sterile applicator test heads into the dip wells by aligning the concave portion of the T-bar with the tray guidepost. Lower the handle of the applicator between the two guide panes, allowing each test head to enter its respective well. The test head number on the applicator will always enter the matching well number on the tray because the applicator can only be inserted in the correct position. The Multi-Test II Tray is now ready for use.

Remove each Multi-Test II sterile disposable applicator from its container by positioning the applicator tray with the blue dots facing away from you. Grasp the sealed label at the blue dot and pull it back towards you. This will allow the applicator to be in the correct position for placing in the Multi-Test II Tray.

Multi-Test II Dip Well Tray and Applicator

The Allergy Test from Revergence Healthcare is used to identify and diagnose the allergens a patient reacts to. With the use of this Allergy Test, the patient and healthcare provider will have a better understanding of their allergies and what can be done to avoid and control them.

About the Test: This Allergy Test uses the percutaneous skin scratch method to test for allergen sensitivity. The skin test involves scratching the patient’s skin with an applicator device that allows the healthcare provider to test for eight (8) allergens at a time per applicator. After the test has been completed, each test site will react to the antigens administered; results will be measured and recorded.

Before the Test: Ensure the patient has had a physical exam and the following forms have been completed: Allergy Patient History Form, Allergy Testing Information and the Patient Consent Form. The healthcare provider will also review a list of medications that should be discontinued prior to the Allergy Test (refer to the list of medications that may interfere with testing, pg 11).

After the Test: A positive result to an allergen will cause redness and/or a wheal to appear at each reactive allergen site. A wheal is a tiny bump that looks like a mosquito bite. The wheal indicates that the patient is allergic to the allergen tested. Most patients will not experience any discomfort during the test. The healthcare provider will discuss with the patient what they are allergic to and best treatment options. Each patient’s allergies will be unique. If allergen avoidance and prescription medications have failed to adequately control the patient’s symptoms, immunotherapy may be the next treatment option.

ALLERGY TEST

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Medications that Interfere with Allergy Testing

Phenergan (Promethazine) Dimetapp Cold and Allergy (Brompheniramine) Claritin (Loratadine) Antivert (Meclizine) Contac (Clemastine) Dramamine (Dimenhydrinate) Periactin (Cyproheptadine) Vicks Nyquil (Doxylamine) Benadryl (Diphenhydramine) Dimetapp Cold (Chlorphenamine) Alavert (Loratadine) Zyrtec (Cetirizine) Atarax (Hydroxyzine) Vistaril (Hydroxyzine)

Clarinex (Desloratadine)

Chlorphen (Chlorpheniramine) Allegra (Fexofenadine)

Astelin (Azelastine) Xyzal (Levocetirizine)

Anti-histamine Hl (1st Generation & 2nd Generation)Discontinue TWO days (48 hours) prior to testing

Tricyclic AntidepressantsDiscontinue SEVEN days (1 week) prior to testing

Adapin (Doxepin) Etrafon (Amitriptyline) Anaframil (Clomipramine) Surmontil (Trimipramine) Asendin (Amoxampine) Norpramin (Desipramine) Sinequan (Doxepin) Tofranil (lmipramine) Elavil (Amitriptyline) Zonalon (Doxepin) Pamelor (Nortriptyline) Vivactil (Protriptyline)

Beta Adrenergic Blocking AgentsShould be discontinued prior to testing; please consult your physician*

Coreg (Carvedilol) Normodyne (Labetalol) Lopressor (Metoprolol) Corgard (Nadolol) Toprol XL (Metoprolol) Visken (Pindolol) Tenormin (Atenolol) Betapace (Sotalol) Bystolic (Nebivolol) lnderal (Propranolol) Zebeta (Bisoprolol) Sectral (Acebutolol)

*On a case-by-case basis, it may be necessary to discuss discontinuation of chronic medications with the patient’s prescribing physician prior to discontinuing the medication for allergy testing. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators in the event of anaphylaxis.

Remove the test kit from the refrigerator and place it on the cart for transport to examination room. Place nine (9) new applicators, still in their unopened boxes, next to the tray so they are ready to be “charged” with the allergens and placed on the patient’s back. Ensure your cart has the following supplies: Consent Form, Test Report Form, Measuring Tool, Allergy Script Pad, and Patient Authorization and Information Forms.

Have Patient read and sign consent form.

Reiterate to patient the time needed to complete the testing will be 45 minutes to 1 hour to ensure accurate amount of time for prep, testing, and result recording.

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Patient must remove upper body clothing with gown provided, open in back. Be sure to have patient place all personal belongings (clothing, jewelry, etc.) in an area they can see during the entire testing period.

Have patient lay flat in the prone position.

Wipe down patient’s back for testing site with alcohol. Select the flat surfaces of the back only (NOT on the spine).

Label the area for each applicator with a skin pen.

Place loaded applicator on the patient’s back in the appropriately marked area.

• Perform rocking motions without lifting the applicator from the patient’s skin.• Remove applicator from patient’s skin in one motion. • Discard applicator in Sharps container on cart. • Repeat until all nine (9) applicators have been applied.

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ALLERGY TEST PROCEDURE

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TESTING

• Consent Form• Test Order Form • Test Report Form • Sublingual Therapy Script

Verify test in applicator section A1 (Histamine) and A2 (Glycerine) have reacted. These are your test controls. If Section A1 and A2 do not react, you do not have a valid test and must be rescheduled. (Note: this typically occurs if the patient has taken medications that interfere with testing. Refer to pg. 11.)

Set timer for 20 minutes.

Gently blot antigen testing site. DO NOT RUB excess antigen across other test spots.

Mark Wheals and flares with skin pen.

Measure and record wheal and flare responses on Report Sheet.

Once all responses are recorded, apply hydrocortisone cream in a circular motion on patient’s back. This cream will stop the reactions and provide immediate relief.

Have patient dress.

Provide patient with Patient Education Packet.

Provide patient with a copy of Report Sheet Results.

The provider should then discuss the Test results and treatment plan with the patient.

AFTER 20 MINUTES...

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ALLERGY TEST PROCEDURE

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If provider and patient agree Sublingual Therapy is the best approach, Fax all four (4) forms, with appropriate signatures to the Pharmacy.

AFTER TESTING

**Disclaimer: The information below is based on AMA’s CPT Assistant and CMS’s Local Coverage Determination (LCD) for allergy testing (LCD L33261). The intent of providing this information is to provide your practice with informational resources and should in no way be interpreted as coding advice or a guarantee of payor coverage. Please ensure you review your carrier guidelines.

BILLING & CODING OVERVIEW

95004 – Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify each number of tests performed.

Example: If the provider tests 70 different allergens and 2 controls, the provider will bill 95004 with 72 units.

Review your payor medical policies regarding Allergy Testing frequency guidelines. Each payor may have different rules regarding how often Allergy Testing should be done and the number of allergens that can be tested. Obtain from each patient the date of his/her last Allergy Test (Referenced on the Allergy Patient Medical History Form).

CPT CODING

Medically necessary diagnoses are dependent on individual carrier guidelines. You must review your carrier guidelines to ensure proper ICD-10 diagnoses are established prior to allergy testing. Each carrier may be different; however, Revergence Healthcare, LLC, has provided a list of ICD-10 diagnosis codes CMS has identified within their Local Coverage Determination Policy L33261 that meet medical necessity.

ICD-10 DIAGNOSTIC CODING

Insurance payors require a HCFA 1500 claim form to be completed and submitted if billing by paper and appropriate formatting if billing electronically. A HCFA 1500 claim form has been provided as a SAMPLE for submitting Allergy Testing.

Note the proper location for the date of service, CPT/Procedure code, place of service, and number of units billed.

SAMPLE HCFA 1500

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ICD-10 CODEH10.10 - H10.13 Acute atopic conjunctivitis, unspecified eye - Acute atopic

conjunctivitis, bilateral

Chronic giant papillary conjunctivitis, right eye - Chronic giant papillary conjunctivitis, unspecified eye

Other chronic allergic conjunctivitis

Vasomotor rhinitis - Allergic rhinitis, unspecified

Chronic rhinitis

Mild intermittent asthma, uncomplicated - Severe persistent a asthma with status asthmaticus

Besnier's prurigo - Flexural eczema

Intrinsic (allergic) eczema - Atopic dermatitis, unspecified

Dermatitis due to ingested food

Pruritus, unspecified

Allergic urticaria

Contact urticaria - Other urticaria

Adverse effect of unspecified drugs, medicaments and biological substances, initial encounter - Adverse effect of unspecified drugs, medicaments and biological substances, sequela

Adverse effect of other drugs, medicaments and biological substances, initial encounter - Adverse effect of other drugs, medicaments and biological substances, sequela

Toxic effect of unspecified snake venom, accidental (unintentional), initial encounter - Toxic effect of contact with unspecified venomous animal, undetermined, sequela

Toxic effect of latex, accidental (unintentional), initial encounter - Toxic effect of latex, undetermined, sequel

Anaphylactic reaction due to unspecified food, initial encounter - Anaphylactic reaction due to unspecified food, sequela

Anaphylactic reaction due to shellfish (crustaceans), initial encounter - Anaphylactic reaction due to shellfish (crustaceans), sequela

H10.411 - H10.419

H10.45

J30.0 - J30.9

J31.0

J45.20 - J45.52

L20.0 - L20.82

L20.84 - L20.9

L27.2*

L29.9

L50.0

L50.6 - L50.8

T50.905A - T50.905S

T50.995A - T50.995S

T63.001A - T63.94XS

T65.811A - T65.814S

T78.00XA - T78.00XS*

T78.02XA - T78.02XS*

DESCRIPTION

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ICD-10 CODET78.05XA - T78.05XS* Anaphylactic reaction due to tree nuts and seeds, initial encounter

- Anaphylactic reaction due to tree nuts and seeds, sequela

Anaphylactic reaction due to food additives, initial encounter - Anaphylactic reaction due to food additives, sequela

Anaphylactic reaction due to milk and dairy products, initial encounter - Anaphylactic reaction due to milk and dairy products, sequela

Anaphylactic reaction due to eggs, initial encounter - Anaphylactic reaction due to eggs, sequela

Anaphylactic reaction due to other food products, initial encounter - Anaphylactic reaction due to other food products, sequela

Other adverse food reactions, not elsewhere classified, initial encounter - Other adverse food reactions, not elsewhere classified, sequela

Angioneurotic edema, initial encounter - Angioneurotic edema, sequela

Shock due to anesthesia, initial encounter - Shock due to anesthesia, sequela

Allergy status to penicillin

Allergy status to other antibiotic agents status

Allergy status to sulfonamides status

Allergy status to other anti-infective agents status

Allergy status to serum and vaccine status

Allergy to peanuts - Other insect allergy status

T78.06XA - T78.06XS*

T78.07XA - T78.07XS*

T78.08XA - T78.08XS*

T78.09XA - T78.09XS*

T78.1XXA - T78.1XXS*

T78.3XXA - T78.3XXS

T88.2XXA - T88.2XXS

Z88.0

Z88.1

Z88.2

Z88.3

Z88.7

Z91.010 - Z91.038

DESCRIPTION

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ICD-10 Codes Asterisk Explanation: *ICD-10-CM codes that apply for CPT code 95004 for food allergy testing.

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Revergence Healthcare provides an effective option for allergy immunotherapy in the form of sublingual drops. The formula is a Broad Spectrum Patient-Specific sublingual allergy immunotherapy that contains antigens specific to the patient’s allergy test. Sublingual Drops are safe, easy, and can be administered at home. The therapy is a six (6) step process that gradually increases in concentration every month until the maintenance concentration level is reached by the end of month six (6).

*The patient starts with Week 1 every time they receive a new bottle

Months 1-4: Week 1: Place 1 drop under the tongue twice a day Week 2: Place 2 drops under the tongue twice a day Week 3: Place 3 drops under the tongue twice a day Week 4: Place 4 drops under the tongue twice a day

*Although there may be drops remaining in the bottle (every bottle is overfilled) start the next bottle after 28 days.

Month 5: Place 3 drops under the tongue every day

Month 6+ (Maintenance): Place 3 drops under the tongue every day

Dosing Schedule:

Sublingual Immunotherapy

Dosing Chart in Drops Per Dose

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How to Administer Allergy DropsGently shake the dropper bottle before removing the twist cap.It is important to gently shake the dropper bottle to ensure the proper concentration is delivered per drop. Each bottle is overfilled (for example, 140 drops are required for Months 1-4 but the bottle contains approximately 170 drops). After 28 days, start the next bottle even if drops are remaining. This will keep the therapy on schedule.

The patient should look into a mirror when administering each dose.By looking in the mirror, the number of drops coming out of the bottle can be easily seen to control the dose.

The patient should curl back tongue exposing the area behind the lower teeth.Invert the dropper bottle and gently squeeze the bottle. Dispense the proper number of drops per dosing instructions on the insert card included in the package with the dropper bottle.

After administering the dosage, remove pressure from the dropper bottle. Release your squeeze so the bottle refills with air. Return the bottle to its upright position and replace the cap.

Drops SHOULD NOT be swallowed for two (2) minutes.Hold the drops under the tongue for two minutes ensuring the drops have time to be absorbed by the sublingual mucosa cells entering the blood stream. Note: Though it is safe to swallow the drops, it is important to follow these directions in order to ensure the proper absorption of the drops.

Log the Date and Time the Allergy Drops were taken on the package insert card.This is the best way for the patient to track his/her therapy.

Experiencing any minor symptoms (watery eyes, sniffling, coughing, itching)?If the patient experiences minor symptoms, this indicates the patient has temporarily passed the “allergic threshold.” To avoid this, simply decrease the number of drops taken for one (1) week before proceeding to the next week, resuming regular dose schedule. It is important to remember that every patient is different and therapy can be adjusted to the patient’s needs. Any patient questions should be directed to the provider or the Revergence Healthcare pharmacist at 855.346.0944.

Experiencing a severe reaction? (Difficulty breathing, swelling of the tongue)If the patient experiences a severe reaction, call 911 immediately. If it is not an emergency, notify the physician of this reaction.

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Sublingual vs. Subcutaneous Immunotherapy

Method of Administration

Possible Adverse Reactions

Number of Provider Visits

Allergy Testing Required

Who Should NOT Use

Duration of Treatment

Treatment Frequency/Location

FDA Approved?

Effective

Insurance Coverage for Allergy Testing

Insurance Coverage for Serum

Treatment Time

Monthly Cost

Method of Administration Drops under tongue Shots in arm

Rare itching/tingling in mouth, temporary worsening of allergy symptoms; Extremely rare: hives or anaphylaxis

Swelling, redness, tenderness and/or itching at injection site, worsening of allergic symptoms, wheezing, hives, life-threatening anaphylaxis

Severe immunodeficiency Taking beta-blockers, history of anaphylaxis, young children, infants, severe asthmatics, severe immunodeficiency

Once every 12 weeks 1-2 times every week

Yes, as needed Yes, as needed

3-5 years 4-5 years or more

Yes Yes

2 minutes daily (in the comfort of your home)

Hours weekly (driving to and from doctor, waiting after each shot)

Antigens: Yes Method: Off-Label

Serum: Yes Method: Yes

Yes, but call insurance company for your specific benefits

Yes, but call insurance company for your specific benefits

No, but comparatively low out of pocket cost

Usually yes, but plan-dependent; Check with your insurer.

Daily drops under the tongue/home

Shots 1-2 times per weeks/doctor’s office

Possible Adverse Reactions

Number of Provider Visits

Allergy Testing Required

Who Should NOT Use

Duration of Treatment

Treatment Frequency/Location

FDA Approved?

Effective

Insurance Coverage for Allergy Testing

Insurance Coverage for Serum

Treatment Time

Approx. Total/Month - $68.95 Approx. Total/Month - $120+Monthly Cost

Sublingual Allergy Drops Subcutaneous Injections

Sublingual (SLIT) and subcutaneous (SCIT) immunotherapy are the two most commonly prescribed routes for administering allergen specific immunotherapy (ASI). Below are some comparisons between the two.

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Clinical PresentationAnaphylaxis has many different signs and symptoms and can present differently among patients. The most common manifestation of anaphylaxis is cutaneous, including urticarial and angioedema, and can occur up to 90% of the time. However, the absence of cutaneous signs does not rule out anaphylaxis. The respiratory system is the second most common system affected, including dyspnea, bronchospasm, and wheezing. The gastrointestinal and cardiovascular systems can beaffected as well, including nausea, vomiting, diarrhea, abdominal pain, and hypo-tension. Other less common manifestations can occur such as headache.

Signs and symptoms of anaphylaxis can appear within minutes of exposure to an allergen. Be aware that some reactions can appear greater than 30 minutes after exposure. Anaphylaxis can be biphasic, meaning that symptoms can recur hours after resolution of the initial phase. When this occurs, most of the time it is within 10 hours. Patients should be monitored for at least a few hours after initial resolution of symptoms with consideration of overnight observation after more severe episodes (the optimal duration of the observation period has not been established in the literature). When discharged, patients must be counseled of these facts and strong consideration should be made to provide auto-injectable epinephrine along with instructions for use.

Patient EducationPatients undergoing immunotherapy and those with a history of anaphylaxis should be instructed on how to recognize signs and symptoms of anaphylaxis. They should also be instructed on how to properly administer auto-injectable epinephrine. Family members of children should be educated on recognition and initial treatment of anaphylaxis with epinephrine.

PreparationOffices and facilities administering immunotherapy should be prepared to treat anaphylaxis. Physicians and office staff should have an established protocol in place, which can be reinforced with rehearsal drills. Anaphylaxis treatment medications, in particular epinephrine, should be immediately available and replaced if used or expired. Health providers administering injections should be trained in the recognition and management of anaphylaxis. It is recommended to continually review medications patients take prior to administration of immunotherapy to avoid placing patients at higher risk of a systemic reaction.

ANAPHYLAXIS

**American Academy of Otolaryngic Allergy | Clinical Care Statements | January 2015