Standardized Mite Dermatophagoides Farinae

STANDARDIZED MITE DERMATOPHAGOIDES FARINAE — dermatophagoides farinae injection, solution
STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS — dermatophagoides pteronyssinus injection, solution
Nelco Laboratories, Inc.

WARNINGS

Standardized Allergenic Extract is intended for use by physicians who are experienced in the administration of standardized (AU/mL) allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized allergenic extracts are not directly interchangeable with other allergenic extracts. The initial dose must be based on skin testing as described in the DOSAGE AND ADMINISTRATION section of this insert. Patients being switched from other types of extract to standardized allergenic extracts should be started as though they were coming under treatment for the first time. Standardized Mite extract is NOT directly interchangeable with non-standardized Mite extract.

This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death.(14) Patients should be observed for at least 30 minutes following treatment and emergency measures and personnel trained in their use should be immediately available in the event of a life threatening reaction. (See Precautions)

Allergenic extracts may be used with caution for patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease. (Contraindications)

Extreme caution should be taken when using allergenic extracts for patients who are taking beta-blocker medications. In the event of a serious adverse reaction associated with the use of allergenic extracts, patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodialators.

Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to: MedWatch, The FDA Medical Product Problem Reporting Program, at 5600 Fishers Lane, Rockville, Md. 20852-9787, call 1-800-FDA-1088.

DESCRIPTION

Standardized mite extract is a sterile injectable solution containing the extractable of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% NaCl, 0.08% Na2 HPO4 , 0.036% KH2 PO4 , 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% Na2 HPO4 , 0.036% KH2 PO4 , 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.

CLINICAL PHARMACOLOGY

The mode of action of allergenic extracts is still under investigation. The pharmacological action of allergenic extracts used diagnostically is based on the liberation of histamine and other substances when the allergen reacts with IgE antibodies attached to the mast cells. When allergen extracts are used for therapeutic immunotherapy, the effect is an increase in immunoglobulin G (IgG) and an increased T suppresser lymphocyte which interferes with the allergenic response.(15) Although immunotherapy may be considered as immunosuppression, in which the production of allergen-specific antibody is inhibited, the mechanism of the clinical effectiveness of immunotherapy remains under investigation.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

This product should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of type 1 allergy to mite is made based on skin testing and the benefits of treatment outweigh the risks of an adverse reaction during testing or treatment. Mite extracts are not indicated for use in patients who are not clinically allergic to mite or who are not skin reactive to mite. Limitations on treatment using mite extract should be considered when treating very young patients, geriatric patients or patients suffering from auto-immune disorders or severe and unstable allergic conditions.

WARNINGS

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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