House Dust Mite
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Questions & Answers
Side Effects & Adverse Reactions
Concentrated extract must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of allergenic extract are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in sensitive patients 11. Patients should be informed of this risk and precautions should be discussed prior to initiating immunotherapy (see PRECAUTIONS below).
Allergenic extract should be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist: 1) severe symptoms of rhinitis and/or asthma; 2) infection or flu accompanied by fever; 3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
The dosage must be reduced when starting a patient on fresh standardized mite extract or when transferring a patient from non-standardized or modified extract to standardized extract, even though the labeled strength of the old and new vials may be the same. This is necessary due to a loss of extract potency during storage in the physician's office. The mite allergen content of old and new extract may be compared and adjusted by dosage reduction and/or dilution before the new extract is administered. The amount of new extract given should not exceed 25% of the last dose given from the old vial, assuming both extracts contain comparable amounts of mite allergen. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to treat an adverse allergic reaction.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing.
The use of mite extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook 10.
History
There is currently no drug history available for this drug.
Other Information
Mite extract is a sterile solution containing the extractables of mite whole bodies in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol by volume and 0.4% phenol as a preservative. The mites are grown on a medium of yeast and pork and are handled and cleaned in a manner to remove more than 99% of the food medium. The medium contains no material of human origin.
This extract may be administered by the scratch, prick-puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration.
Intradermal skin tests in patients who were puncture test positive (Sum E ≥ 40 mm) to either D. farinae or D. pteronyssinus extract were performed with extracts of the mite food medium obtained from the same supplier. The results, submitted to the FDA by several manufacturers, were as follows: By intradermal testing, there was 1 positive (Sum E ≥ 20 mm) in 44 individuals at an estimated 1% level of medium content (approximately the same as contained in the mite extract). At a ten-fold increase (estimated 10% medium content), 4 positives in 40 individuals were observed. Two of the individuals who were skin test positive to the mite extract and who also were skin test positive to the medium extract were also skin test positive to an extract of yeast (Saccharomyces sp.) when tested by the puncture method.
The extract is standardized by comparing its relative potency by ELISA competition to a U.S. reference mite extract available from the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. The U.S. reference extract has been assigned a potency of 10,000 AU/mL based on quantitative skin testing1.
Sources
House Dust Mite Manufacturers
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Allermed Laboratories, Inc.
![House Dust Mite, Dermatophagoides Farinae Injection House Dust Mite, Dermatophagoides Pteronyssinus Injection [Allermed Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
House Dust Mite | Allermed Laboratories, Inc.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed.
AU/mL to elicit 50 mm sum of diameter erythema reaction Allergen No. of Persons Mean Range D. farinae
The skin test concentration of 10,000 AU/mL in dropper vials is used for scratch or prick-puncture testing. Puncture tests performed with D. farinae extract on 5 persons sensitive to mite showed a mean diameter wheal of 8.8 mm ± 1.8 mm and mean diameter erythema of 39.2 mm ± 5.3 mm.
Puncture tests with D. pteronyssinus extract on 10 persons sensitive to mite showed a mean diameter wheal of 7.8 mm ± 4.1 mm and mean erythema of 33.7 mm ± 12.0 mm.
Extract for intradermal testing should be prepared by diluting the 10,000 AU/mL stock concentrate in bulk vials with sterile saline with or without human serum albumin.
Intradermal skin tests (0.05 mL) in persons highly sensitive to mite showed the following results:
5
0.0040
0.0013-0.0124
D. pteronyssinus
10
0.0031
0.0001-0.1416
Intradermal extract should be used as follows:
Volume per volume dilutions of 5,000 AU/mL and 10,000 AU/mL concentrates to provide a ten-fold dilution series. Vial No. w/v Dilution of
Intradermal tests should only be performed after a scratch or prick-puncture test has been administered with a negative result. Patients who do not react to a valid scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 10 AU/mL (1:1,000 v/v of the 10,000 AU/mL concentrate). If this test is negative, a second intradermal test may be performed using a 100 AU/mL (1:100 v/v dilution of 10,000 AU/mL concentrate). Skin tests are graded in terms of the wheal and erythema response noted at 1 5 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.
Therapeutic
The dosage of mite extract administered by subcutaneous injection is highly individualized and varies according to the degree of sensitivity of the patient, his clinical response and tolerance to the extract administered during the early phases of an injection regimen. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be 0.05 mL of a 0.1 AU/mL dilution or as established by skin test titration. The amount of allergenic extract is increased at each injection by not more than 50% - 100% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of the concentrate may be painful due to the glycerin content of the extract.
The optimal interval between doses of mite extract has not been definitely established. However, as is customarily practiced, injections are given one or two times per week until the maintenance dose of extract is reached. At this time, the injection interval may be increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, too or three dilutions may be made depending on a consideration of the components and the patient's sensitivity The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter (25%) of the previous dose.
The usual duration of treatment has not been established. A period of three to five years of injection therapy constitutes an average course of treatment.
Children and older age patients appear to tolerate injections of allergenic extract well, and no special recommendations need to be made for these groups.
Preparing Dilutions
To prepare dilutions for intradermal skin tests and therapeutic use, the stock concentrate may be diluted as shown in Table 1. Vial #1 is made by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. Vial #2 is made by adding 1.0 mL of Vial #1 to 9.0 mL of sterile diluent. This process is repeated until the desired concentration is achieved. In each case, the subsequent vial is made by adding 1.0 mL of the previous dilution to 9.0 mL of sterile diluent. The number of allergy units per mL in each dilution is shown in table below.
Concentrate 5,000 AU/mL
Concentrate
AU/mL 10,000 AU/mL
Concentrate
AU/mL 1
1:100,000
0.05
0.1
2
1:10,000
0.5
1.0
3
1:1,000
5.0
10.0
4
1:100
50.0
100.0
5
1:10
500.0
1,000.0
6
No Dilution
5,000.0
10,000.0
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