Standardized Mite Dermatophagoides Farinae Recall
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Questions & Answers
Side Effects & Adverse Reactions
Standardized Mites extract labeled in AU/mL are not interchangeable with non-standardized mite extracts.
Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.
DO NOT INJECT INTRAVENOUSLY. All concentrates of allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death. Allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma, (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
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FDA Labeling Changes
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Standardized mite allergenic extracts are intended for use in the diagnosis and therapy of D.farinae and D.pteronyssinus mite allergy, as established by allergy history and skin test reactivity (6,10). Standardized Mite extracts are not interchangeable with non standardized mite extracts. To select patients for a confirmation of allergic disease diagnosis and/or treatment with allergen extracts, screening tests should be done using in vivo identification testing methods (i.e. scratch or intradermal testing).(13)
Standardized mite extract containing equal parts of D.farinae and D.pteronyssinus is intended for therapy only. The use of standardized mites extract is indicated for hypersensitization treatment and may be used as part of the over-all management of the allergic patient. This treatment is particularly to be recommended when a patient's sensitivity to mite has been determined initially by scratch or intradermal skin tests.
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Standardized mite extract is a sterile injectable solution containing the extractable of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, distilled water for injection, 0.4%, phenol as preservative and 50% glycerin by volume in sterile containers. All extracts are aseptically filled. Standardized mite extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections.
It has been recognized that mites are one of the most common allergens in House Dust (1,2). Recent research and extensive clinical trials have shown that the mite component is important enough to separate it from the other antigenic components of House Dust. The two species of Dermatophagoides are found in the United States.(4)
Persons thought to be allergic to House Dust should be tested for sensitivity to mites. Standardized extracts have been prepared to diagnose and treat with D. farinae and D. pteronyssinus.
The Allergy Units are assigned to these extracts based on the relative potency by ELISA Inhibition to the Center for Biologics Evaluation and Research (CBER) reference. The CBER mite reference preparation has been assigned 10,000 AU/mL, based on quantitative skin assays.(11)
Extracts are prepared from supplied raw material containing greater than 99% pure adult mites and mite stages by actual count. The mites have been grown on a medium containing yeast and pork products. Cleaning of the raw material removes at least 99% of the medium. This medium contains no material of human origin. The extracting fluid contains 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, distilled water for injection, 0.4% phenol as preservative and 50% glycerin by volume as stabilizer.
The raw material is extracted with diluent, glycerinated, and the potency on the label is expressed in Allergy Units (AU/mL). Several manufacturers submitted intradermal skin test data on Biopol Laboratories mite medium extract using patients who were puncture test positive (Σ E ≥ 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (Σ E ≥ 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.(5) Two of the individuals who were skin test positive to mite extract and who were also skin test positive to mite medium extract were also skin tested by the puncture method with an extract of yeast (Sacchoromyces spp) and were positive.