Standardized Mite
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES BOTH THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT'S SENSITIVITY TOLERANCE. Refer to boxed “WARNINGS" and "OVERDOSAGE" section.
Epinephrine 1:1000 should be available. When changing immunotherapy from an unstandardized to an AU/ml standardized allergenic extract, dose adjustment, if indicated, should be based on such considerations as the results of skin endpoint titration (see "INDICATIONS AND USAGE" section). Patient re-evaluation may be necessary. Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. DO NOT INJECT INTRAVENOUSLY. Proper measurement of the dose and caution in making the injection will minimize reactions. Patients should be detained for twenty to thirty minutes after injection and advised to notify the office immediately if symptoms or reactions occur.
Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced to 75%. Also, this extract should be temporarily withheld or dosage reduced in the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms.
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FDA Labeling Changes
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Uses
INDICATIONS AND USAGE
Standardized Mite allergenic extract is indicated for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. An orderly approach to the diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.
Mite mixtures should not be used for diagnostic skin testing. The individual mites should be used. Mite mixtures may be used for immunotherapy to treat patients who demonstrated sensitivity to both D. farinae and D. pteronyssinus mites. Patients who react to both D. farinae and D. pteronyssinus have demonstrated a significant cross-reactivity. Caution should be used in escalating treatment with mite mixtures.21
PRICK-PUNCTURE TESTING: A positive control using Histamine Phosphate is important to identify those patients whose skin may not be reactive due to medications, metabolic or other reasons. A diluent control, if negative, would exclude false-positive reactions due to ingredients in the diluent or patients who have dermatographism.
To identify highly sensitive individuals and as a safety precaution, it is recommended that prick-puncture test using a drop of the extract concentrate (10,000 AU/ml) be performed prior to initiating very dilute intradermal testing. Prick-puncture testing is performed by placing a drop of extract concentrate on the skin and puncturing the skin through the drop with a small needle such as a bifurcated vaccinating needle. The most satisfactory sites on the back for skin testing are from the posterior axillary fold to 2.5 cm from the spinal column, and from the top of the scapula to the lower rib margins. The best areas on the arms are the volar surfaces from the axilla to 2.5 or 5 cm above the wrist, skipping the anticubital space. Glycerinated Mite extracts containing 10,000 AU/ml are recommended for prick-puncture testing. Skin reactions are based on size of erythema and wheal. For interpretation of skin reactions, refer to chart below.
| GRADE |
mm ERYTHEMA |
mm WHEAL |
| 0 |
less than 5 |
less than 5 |
| +/- |
5-10 |
5-10 |
| 1+ |
11-20 |
5-10 |
| 2+ |
20-30 |
5-10 |
| 3+ |
31-40 |
10-15 or with pseudopods |
| 4+ |
greater than 40 |
greater than 15 or with many pseudopods |
Smaller, less conclusive reactions may be considered positive in conjunction with a definitive history of symptoms on exposure to the mite allergen. The more sensitive the patient the higher the probability that he/she will have symptoms related to the exposure of the offending allergen. Hence, the importance of a good patient history. Less sensitive individuals can be tested intradermally with an appropriately diluted extract.
A clinical study using the same patients with positive prick-puncture test (10) using the ID50EAL Method, Intradermal Dilution for 50 mm Sum of Erythema D50 Determines the Allergy Unit, has demonstrated the following:
Skin test by prick-puncture test using Standardized D. farinae Mite, 10,000 AU/ml was performed in 10 patients. The mean sum of erythema diameter was 76.6 mm (Range 45-104 mm). Skin test by prick-puncture test using Standardized D. pteronyssinus Mite, 10,000 AU/ml in 10 patients, the mean sum of erythema diameter was 74.7 mm (Range 43-109 mm).
STANDARDIZED MITE ALLERGENIC EXTRACTS
LABELED 10,000 AU/ml
| 10,000 AU/ml 1:3 Dilutions |
10,000 AU/ml 1:5 Dilutions |
10,000 AU/ml 1:10 Dilutions |
| *C 10,000 3-1 3,333 3-2 1,111 3-3 370.37 3-4 123.45 3-5 41.15 3-6 13.71 3-7 4.57 3-8 1.52 3-9 0.508 3-10 0.169 3-11 0.056 3-12 0.018 3-13 0.0063 3-14 0.0021 3-15 0.0007 |
*C 10,000 5-1 2,000 5-2 400 5-3 80 5-4 16 5-5 3.20 5-6 0.64 5-7 0.128 5-8 0.0256 5-9 0.00512 5-10 0.00102 |
*C 10,000 10-1 1,000 10-2 100 10-3 10 10-4 1 10-5 0.10 10-6 0.01 10-7 0.001 10-8 0.0001 10-9 0.00001 |
*C = Concentration
SINGLE DILUTION INTRADERMAL TESTING: The surface of the upper and lower arm is the usual location for skin testing. It is important that a new, sterile, disposable syringe and needle be used for each extract tested. Intracutaneous test dilutions should be made with aqueous diluent. (1) Start testing with the most dilute allergenic extract concentration. (2) A volume of 0.02-0.05 ml should be injected slowly into the superficial skin layers making a small bleb (superficial wheal). (3) For patients without a history of extreme sensitivity, a prick-puncture test of less than 2+, the initial dilution for skin testing should contain 0.02 to 0.06 AU/ml (see Table I). For very sensitive patients with a prick-puncture of greater than 2+, a further dilution should be made to 0.002 to 0.006 AU/ml (see Table I). If after 20 minutes no skin reaction is obtained, continue the testing using five-fold or ten-fold increments in potency until a reaction of 1+ or until the concentration of 2,000 AU (five-fold) or 1,000 AU (ten-fold) has been tested with a glycerine control. Glycerine may be used at a dilution of 0.5% as long as 0.5% glycerine produces negative control. The diluent should be tested and included in the interpretation of the skin reactions.16
INTRADERMAL TESTING–SKIN ENDPOINT TITRATION: The allergenic extracts to which the patient is sensitive, the patient's degree of sensitivity and the dose of allergen to be used in immunotherapy can be determined through the use of intracutaneous skin tests involving progressive five-fold dilutions of allergenic extracts, prepared and refrigerated at 2-8° C. The critical variable is the size if the wheal and erythema produced by the intracutaneous injection of 0.01 to 0.02 ml of the test allergen producing a 4 mm diameter superficial skin wheal. For patients demonstrating a prick-puncture skin test of less than 2+, an initial screening dilution of 0.02-0.06 AU/ml is safe (see Table I). For patients demonstrating a prick-puncture skin test greater than 2+, an initial screening dilution of 0.002 to 0.006 AU/ml is safe. The skin endpoint is detected by noting the dilution that produces a wheal 2 mm larger than non-reacting dilutions (5 mm negative wheal) until progressive whealing with each five-fold increase in test potency occurs, i.e., a 5 mm (negative), 7 mm, 9 mm, 11 mm is the normal sequence of whealing. The 7 mm wheal would be the endpoint. The endpoint dilution is used as an initial dose concentration for immunotherapy. An endpoint dose of 0.15 ml is a safe initial dose to be followed by escalation to the optimal maximum tolerated dose for each individual.
Using Standardized D. farinae Mite, 10,000 AU/ml on 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.4). Using Standardized D. pteronyssinus Mite 10,000 AU/ml in 10 patients, the mean AU for 50 mm sum of erythema was 0.02 AU (Standard deviation was 1.7).
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
The extract is sterile and intended for dilution prior to skin testing and/or immunotherapy. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. The route of administration for immunotherapy is subcutaneous. The designation AU/ml (Allergy Units per ml) is unitage based upon the relative potency of this standardized mite extract when compared by ELISA competition to the F.D.A. Mite Allergenic Reference Standard labeled 10,000 AU/ml assigned on the basis of quantitative skin testing by the ID50EAL Method.1,2,3,4,5,16 Lower concentrations (e.g. 5,000 AU/ml and 3,000 AU/ml) are prepared by dilution of stock concentrates. Mite mixtures containing equal volumes of D. farinae and D. pteronyssinus are available at 5,000 AU/ml, 2,500 AU/ml and 1,500 AU/ml.
Active allergens are described by common and scientific name on the stock concentrate container label.
INGREDIENTS: Extract of Standardized Mites contain at least 99.0% adult mites and mite stages. This product may contain trace amounts of yeast and/or pork products; sodium chloride 0.95%; sodium bicarbonate 0.24%; 50% v/v glycerine as stabilizing agent and preservative.
Following is a brief description of the standardized quality procedures applied to these extracts:
1. The source material is carefully selected from whole body adult mites and mite stages cultured from a medium containing no material of human origin. The source material is extracted with a saline buffer and 50% v/v glycerine.
2. Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (erythema greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (erythema greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive to the mite extract and who were also skin test positive to the mite medium extract were also skin tested by the puncture method with an extract of yeast (Saccharomyces sp.) and were positive.
3. A ninhydrin protein analysis is completed to compare with the standard extract.
4. Each lot is standardized against the F.D.A. reference standard extract for total biologic activity by means of ELISA competition.
5. The standardized mite extract is analyzed for glycerine content to insure a minimum of 50% v/v glycerine for optimal stability during the entire dating period.
Sources
Standardized Mite Manufacturers
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Antigen Laboratories, Inc.
![Standardized Mite, Dermatophagoides Pteronyssinus Injection, Solution Standardized Mite, Dermatophagoides Farinae Injection, Solution Mixture Of Standardized Mites Injection, Solution [Antigen Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Mite | Antigen Laboratories, Inc.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Normally, immunotherapy with standardized mite allergenic extracts can be started with 0.15 ml of the endpoint of reaction.
If the first injection of the initial dilution of extract is tolerated without significant local reaction, increasing doses by 5-20% increments of that dilution may be administered. The rate of increase in dosage in the early stages of treatment with highly diluted extracts is usually more rapid than the rate of increase possible with more concentrated extracts. This schedule is intended only as a guide and must be modified according to the reactivity of the individual patient. Needless to say, the physician must proceed cautiously in the treatment of the highly sensitive patient who develops large local or systemic reactions.
Some patients may tolerate larger doses of the standardized mite allergenic extract depending on patient response.7 Because dilute extracts tend to lose activity on storage, the first dose from a more concentrated vial should be the same or less than the previous dose.8,12
The physician who undertakes immunotherapy should be concerned with the degree of sensitivity of the patient. See "INDICATIONS AND USAGE" section. Strongly positive skin tests may be risk factors for systemic reactions. Less aggressive immunotherapy schedules may be indicated for such patients. Maintenance dose potency must be established by the physician's clinical observation and experience.6,13
Serial five-fold or ten-fold dilutions of the extract are used to make more dilute extract concentrations. Other concentrations can be prepared by appropriate dilutions. In brief, the allergist can prepare any dilution of extract that is considered appropriate for the patient.
Dosages progressively increase thereafter according to the tolerance of the patient at intervals of one to seven days until, (1) the patient achieves relief of symptoms, (2) induration at site of injection is no larger than 50 mm in 36 to 48 hours, (3) a maintenance dose, the largest dose tolerated by the patient short of aggravating existing symptoms, systemic symptoms, or anaphylaxis, or demonstrates untoward reactions that indicate the dose to be excessive. This maintenance dose may be continued at regular intervals perennially. It may be necessary to adjust the progression of dosage downward to avoid local and constitutional reactions.
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