Quick Guide: SLIT Protocol

Transcription

1 Quick Guide: SLIT Protocol Mixing allergy drops in your dermatology practice. Countless Pet Allergies. One Solution. ACTTallergy.com V009v2

2 You have a choice for your allergy products with the ACTT Allergy Management Program provided by ALK. Since 1923, ALK has exemplified scientific leadership in the field of allergy research and in the treatment of allergic disease in humans. We are proud to extend our experience into the animal health industry by supporting veterinary dermatologists in the treatment of allergic pets. We monitor the purity, complexity, potency and stability of each product to ensure quality raw materials for every extract. ALK has 100% control of the extract manufacturing process and is 100% dedicated to allergic care. Benefits of partnering with ALK and the ACTT Allergy Management Program: Over 90 years experience of manufacturing allergenic extracts Investing in research of allergy care for veterinarian dermatologists Can assist your practice in implementing a SLIT strategy or provide treatment sets formulated to your specifications. Dedicated staff specializing in veterinary allergy to assist you with difficult cases and dose modification. ALLERGY IS OUR BUSINESS.NOTHING ELSE.

3 Protocol Overview ALK employs a weight:volume (w/v) dosing strategy. For small animals, two protocols have been devised. An animal s species and weight determines the w/v protocol. 1:100: Canine >20 lbs 1:500: Canine 20 lbs and Feline In the Induction Protocol, two lower concentration vials are utilized. The lower vial concentrations are five-fold dilutions of the maintenance or strongest dosage. For Canine > 20 lbs For Canine < 20 lbs and Feline 1 1:2,500 1:12, :500 1:2, :100 1:500 Supplies Allergenic Extract Item # Description Veterinary product catalogs available for a complete list of available products. Pump Vials ml Glass Amber Vial with 50 μl Metered Pump 50% Glycerin GLY ml vial Syringes SYR80429 Mixing Syringe, 1.0 ml, 23 G x 1/2, case of 1,000 in trays of 25 Sterile Empty Vials SEV ml silver capped vial

4 Large Canine (Greater than 20 lbs) Protocol Step 1: Create Maintenance Vial (Red Vial) 1. Determine the appropriate amount of each allergen and diluent based on the number of allergens using Table I. When formulating allergy drops, the glycerin is added first, and allergens are added second. 2. Add 50% glycerin diluent to an empty 15.0 ml amber glass vial. 3. Add each allergen to the amber glass vial containing glycerin. 4. Vial will contain 15.0 ml 1:100 w/v concentration. For example: Based on the chart a six allergen vial will use 0.2 ml allergenic extract for each allergen and 13.8 ml of 50% glycerin diluent. Number of Allergens Volume/ Individual Allergen (ml) Table I Total Allergen Volume (ml) 50% Glycerin Volume (ml) Note: ALK doubles the amount of certain allergens (flea, cat and cedar) due to low PNU. Adjust allergen volume and 50% glycerin as needed, e.g., 6 allergens, 1 being flea. 5 allergens at 0.2 ml and flea at 0.4 ml ml 50% glycerin. Step 2: Create Treatment Set 1. Create 1:500 w/v concentration (Blue Vial): Add 2.8 ml 50% glycerin diluent to an empty 15.0 ml amber glass vial. Add 0.7 ml 1:100 w/v concentration to an amber glass vial containing glycerin. Vial will contain 3.5 ml of 1:500 w/v concentration. This volume is sufficient for this stage of induction. 2. Create 1:2,500 w/v concentration (Green Vial): Add 2.4 ml 50% glycerin diluent to an empty 15.0 ml amber glass vial. Add 0.6 ml 1:500 w/v concentration to an amber glass vial containing glycerin. Vial will contain 3.0 ml 1:2,500 w/v concentration. This volume is sufficient for this stage of induction.

5 Small Canine (Less than 20 lbs) & Feline Protocol Step 1: Create a 1:100 concentrate vial based on Large Canine Protocol Due to the small allergen volume it is recommended to prepare a 1:100 vial for subsequent dilutions. Formulate using Table I. However, use a 20 ml sterile empty vial in place of amber glass vial. This vial can be labeled, dated, and stored at 4 C for up to one year and utilized for maintenance vial refills. Step 2: Create Maintenance Vial (Red Vial) 1. Add 12.0 ml 50% glycerin diluent to an empty 15.0 ml amber glass vial. 2. Add 3.0 ml 1:100 w/v concentration to amber glass vial containing glycerin. 3. Vial will contain 15.0 ml 1:500 w/v concentration. 4. Store the remaining 1:100 w/v concentration for up to one year. Note: Label vial clearly with patient name and expiration date. Step 3: Create Treatment Set 1. Create 1:2,500 w/v concentration (Blue Vial): Add 2.8 ml 50% glycerin diluent to an empty 15.0 ml amber glass vial. Add 0.7 ml 1:500 w/v concentration to amber glass vial containing glycerin. Vial will contain 3.5 ml 1:2,500 w/v concentration. This volume is sufficient for this stage of induction. 2. Create 1:12,500 w/v concentration (Green Vial): Add 2.4 ml 50% glycerin diluent to an empty 15.0 ml amber glass vial. Add 0.6 ml 1:2,500 w/v concentration to amber glass vial containing glycerin Vial will contain 3.0 ml 1:12,500 w/v concentration. This volume is sufficient for this stage of induction. Treatment Schedule Large Canine Induction Schedule Small Canine & Feline Induction Schedule Weeks Concentration Pumps Weeks Concentration Pumps 1 1 pump, 1x daily 1 1 pump, 1x daily 1:2,500 1:12, pump, 2x daily 2 1 pump, 2x daily 3 1 pump, 1x daily 3 1 pump, 1x daily 1:500 1:2, pump, 2x daily 4 1 pump, 2x daily 5 1 pump, 1x daily 5 1 pump, 1x daily 1:100 1: pump, 2x daily pump, 2x daily Large Canine Maintenance Schedule Small Canine & Feline Maintenance Schedule Weeks Concentration Pumps Weeks Concentration Pumps 1 1 pump, 1x daily 1 1 pump, 1x daily 1:100 1: pump, 2x daily pump, 2x daily

6 Pet Owner Instructions Getting Started with Allergy Drops for Your Pet Take Inventory You have received your pet s initial allergy treatment. This is the first step to a happier, healthier pet. In your kit, you have received: Drops schedule that will instruct you how often and how many drops to give to your pet. Dropper pumps and treatment bottles in Green, Blue, and Red. Know the Treatment You have received a set of bottles for your pet. For some allergic pets, you will have a set of three bottles (1 green, 1 blue, 1 red). For pets sensitive to more allergens, you will have six bottles (2 green, 2 blue, 2 red) labeled Set 1 and Set 2. Review Important Information and the How To Guide before giving your pet the first dose. Start Always begin with the GREEN BOTTLES. If you have received bottles labeled Set 1 and Set 2 you will use both green bottles AT THE SAME TIME. Drops are given twice daily, usually morning and evening. The key to success is frequency so be sure to follow your schedule as closely as you can. Important - Read Before Beginning Once the pump is attached, store bottles in an upright position to prevent leaking. Refrigerate upon arrival, but do not freeze. Keep your drops schedule in a safe place so you can easily refer to it. A weight-appropriate dose of oral antihistamine given daily will help with your pet s comfort. Begin with the GREEN bottle. If you have more than one green bottle, both should be given at the same time. Pets should not eat or drink for 10 minutes before or after treatment. Record the Results Track your pet s progress with a treatment journal. The symptom scale will help you as you monitor your pet. Be sure to thoroughly read the Signs of Reaction before you begin. How To Administer Your Pet s Drops 1. Determine if your pet will either be given a single or double treatment set. When administering a double treatment set, drops from Set 1 and Set 2 should be given on the same day, at the same time. 2. Screw the pump to the bottle and prime the pump by depressing it several times until a drop is released. 3. Rest the dispensing nozzle on the lower lip between the gum line and cheek. 4. Depress the pump quickly and firmly so that the dose is released. Follow dosing schedule for number of pumps. 5. Repeat with second bottle of the same color, if necessary. Signs of Reaction If your pet experiences any of the following, contact your veterinarian immediately. reddening of the skin hives itching heightened agitation vomiting diarrhea loss of appetite difficulty breathing unusual drowsiness Frequency of dosing is essential to the success of allergy drops. Follow your schedule as closely as possible. Transitioning Between Bottles 1. Remove the pump and place it on the new bottle. 2. Depress the pump 4 to 5 times to clear the pump of any remaining old allergen concentration. IMPORTANT: Do not rinse the pump under water when changing between bottles.! WARNING As with any medication, immunotherapy is not without risk or side effects. Allergy drops are safe and effective; however, although rare, serious systemic reactions may occur. Review Signs of Reaction before beginning. Contact your veterinarian immediately if your pet s symptoms worsen or a severe reaction occurs.

7 Frequently Asked Questions 1. Why does ALK use weight:volume rather than PNU for dosing recommendations? PNU/mL dosing recommendations have not been established for individual allergens or allergen groups. 1 The PNU/mL of extracts will vary between manufacturers; therefore, ALK formulates all treatment sets according to weight:volume. In table II, approximate PNU/ ml ranges used by ALK in sublingual immunotherapy are listed. Table II Allergen Group Allergen Examples PNU/mL Trees* White Oak,Eastern Cottonwood, White Ash 50, ,000 Grasses Timothy, Johnson, Bermuda 40, ,000 Weeds Short Ragweed, Lambs Quarters, Rough Pigweed 60, ,000 Molds Alternaria alternata, Aspergillus fumigatus 40,000 Dust Mite D. farinae, D. pteronyssinus 20,000-30,000 Insects** Flea, Mosquito, Cockroach 20,000-40,000 Epithelia & Fiber*** Cat, Mouse, Dog, Kapok 20,000 *Trees with lower PNU/mL: Cedar at 10,000 and Pine at 20,000 **Insect with lower PNU/mL: Flea at 2,000. ***Epithelia and Fiber with lower PNU/mL: Human epithelia at 500 and Cotton Linters at 3, What efficacy rates have been observed by ALK? ALK tracked the progress of 210 patients (canine, feline and equine). Post-induction schedule, 75% reported moderate to significant improvement. Post first maintenance schedule, 82% (n=134) reported moderate to significant improvement. 3. Should sublingual immunotherapy vials be stored in the refrigerator? Yes. Allergens formulated in 50% glycerin have shown stability at room temperature for short periods (1 month). Degradation was decreased but still significant when allergens formulated in 50% glycerin were stored at room temperature for longer periods. Allergens in 50% glycerin stored at 4 C showed minimal degradation. 2,3,4 4. Should pollen and epithelia allergens be formulated in a separate vial from mold and insect allergens? Mold and insect allergens show high proteolytic enzyme activity. They can degrade allergens with lower proteolytic enzyme activity, like pollens. 5,6 Lower rates of efficacy have been observed when pollens and molds were mixed. 7 Formulation into separate vials is recommended. 1,5-7 Dust mite allergens can be included with either pollens or molds and insects What is the maximum number of allergens that can be included in one vial? Disagreement exists about the maximum number of allergens to include in one vial. Typical recommendations range between 8 12 allergens. 1,8,9 ALK protocols do not exceed 12 allergens per vial. 6. What percent of patients react to Sublingual Immunotherapy? ALK has found that <6% of patients require modifications to their immunotherapy due to reactions. 7. Does sublingual immunotherapy need to be administered daily? Yes, ALK strongly recommends that drops be taken daily. There are no veterinary studies that have illustrated the efficacy of every other day frequency dosing. 8. Can another sublingual pump that dispenses a different amount of liquid be used? ALK sublingual protocols have only employed a 50 μl metered dose pump. ALK Item #: 80158, 15.0 ml amber glass vial with 50 μl Metered Pump.

8 Visit Us Online Order Online 24 hours a day. myalkus.com Orders customerservices@alk.net Telephone Orders :30 am - 5:30 pm CST Mon-Wed 7:30 am - 5:00 pm CST Thurs - Fri Serum Testing and Treatment Telephone Orders Fax Orders References: 1. Miller, W. H., Griffin, C. E., Campbell, K. L., & Muller, G. H. (2013). Muller and Kirk s Small Animal Dermatology7: Muller and Kirk s Small Animal Dermatology. Elsevier Health Sciences. 2. Cox, L., Nelson, H., Lockey, R., Calabria, C., Chacko, T., Finegold, I.,... & Wallace, D. (2011). Allergen immunotherapy: a practice parameter third update. Journal of Allergy and Clinical Immunology, 127(1), S1-S Plunkett, G Stability of allergen extracts used in skin testing and immunotherapy. Current Opinion in Otolaryngology & Head and Neck Surgery, 16, Plunkett, G Stability of Major Allergen Proteins in Extract Mixes Diluted in Human Serum Albumin (HSA), Normal Saline (NSP), or Glycerin (GLY), Journal of Allergy and Clinical Immunology, 119(1), S Esch, R. E. (2008). Allergen immunotherapy: what can and cannot be mixed?. Journal of Allergy and Clinical Immunology, 122(3), Grier, T. J., LeFevre, D. M., Duncan, E. A., & Esch, R. E. (2007). Stability of standardized grass, dust mite, cat, and short ragweed allergens after mixing with mold or cockroach extracts. Annals of Allergy, Asthma & Immunology, 99(2), Schnabl, B., Bettenay, S. V., Dow, K., & Mueller, R. S. (2006). Results of allergen-specific immunotherapy in 117 dogs with atopic dermatitis. The Veterinary Record, 158(3), Warren, S. (2012). The role of allergen specific immunotherapy in the treatment of canine atopic dermatitis: Part 1. Companion Animal, 17(9), Griffin, C. E., & Hillier, A. (2001). The ACVD task force on canine atopic dermatitis (XXIV): allergen-specific immunotherapy. Veterinary Immunology and Immunopathology, 81(3), ALK efficacy and reaction data available upon request. ALK products are available to licensed veterinarians only. V048v4