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Standardized Mite Dermatophagoides farinae
Overview
What is Standardized Mite Dermatophagoides farinae?
Standardized mite extract is a sterile injectable solution containing the extractable of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% NaCl, 0.08% NaHPO, 0.036% KHPO, 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 . 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.
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.
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% NaHPO, 0.036% KHPO, 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. 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.
What does Standardized Mite Dermatophagoides farinae look like?
What are the available doses of Standardized Mite Dermatophagoides farinae?
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What should I talk to my health care provider before I take Standardized Mite Dermatophagoides farinae?
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How should I use Standardized Mite Dermatophagoides farinae?
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 . 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).
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.
It is imperative that the physician determine the initial dose of the product by skin testing. Patients being switched from a Standardized Mite extract to a new Standardized Mite extract (both labeled in AU/mL) should be skin tested with both extracts to determine the relative potency of the extracts and the dosage adjusted accordingly.
For safe and effective use of allergen extracts, sterile solutions, vials, syringes, etc. should be used and aseptic precautions observed in making dilution's. The usual precautions to be observed in administering extracts are necessary. A sterile tuberculin syringe graduated in 0.1 mL units to measure each dose for the prescribed dilution should be used.
Recommended dosage and range:(Diagnostic) The concentration of Standardized Mite extract for Scratch or Prick-puncture testing is 10,000 AU/mL, glycerinated, supplied in 5 mL dropper vials. Skin tests are graded in terms of the wheal and erythema response noted at 10 to 20 minutes. Wheal and erythema size may be recorded by actual measurement or the extent of both responses.
Prick-puncture tests on Mite allergic subjects: 10 puncture tests (bifurcated needle) on mite allergic subjects yielded the following:
Intradermal tests
Patients with a negative scratch or prick-puncture test:
To prepare a 50 AU/mL dilution from 10,000 AU/mL vial:
Take 5.0mL of 10,000AU/mL + 5.0 mL of diluent = Vial A @5,000 AU/mL.
Take 1.0 of Vial A + 9.0 mL diluent = Vial B @ 500 AU/mL.
Take 1.0 of Vial B + 9.0 mL diluent = Vial C @ 50 AU/mL.
Patients tested only by the intradermal method:
Recommended dosage and range: (Therapeutic)
After therapeutic injections patients should always be observed for at least 30 minutes. If adverse reactions appear, the next therapeutic injection of extract should be reduced to the dose which does not elicit a reaction and subsequent doses increased slowly. If local reactions occur, reduce subsequent injections to a dose which did not elicit this reaction.
Preparation Instructions:
Intervals between doses:
Duration of Treatment:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
What interacts with Standardized Mite Dermatophagoides farinae?
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.
What are the warnings of Standardized Mite Dermatophagoides farinae?
Serious adverse reactions should be reported to Nelco Laboratories immediately and a report filed to:
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.
What are the precautions of Standardized Mite Dermatophagoides farinae?
General Information:
Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment.
To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing. Patients should be observed for 30 minutes after any test.
Information for Patients:
Drug Interaction:
Carcinogenesis, mutagenesis, impairment of fertility.
Long term studies in animals have not been conducted with allergenic extracts, especially mite extracts, to determine their potential carcinogenicity, mutagenicity or impairment of fertility.
Pregnancy: Category C.
Nursing Mothers:
Pediatric Use:
What are the side effects of Standardized Mite Dermatophagoides farinae?
Anaphylaxis and other systemic reactions may occur such as induced asthma, itching of nose and throat, breathlessness, urticaria and local reactions. Local reactions can be defined as an area of large erythema, swelling or pruritus at the injection site. Further indications of adverse reactions are edema, wheezing, dyspnea, locomotive impairment, marked perspiration, coughing, hypertension, shock and upper airway obstruction.
Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema and hypotension. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause shock and loss of consciousness. Fatalities have occurred rarely. These systemic reactions occur with varying frequency in different clinics. To some extent, the reaction rate is related to the type and dose of administered extract and to the degree of sensitivity of the patient. Despite all precautions, occasional reactions are unavoidable.
Reports from regulatory authorities in Sweden to the Center for Biologics Evaluation and Research (CBER) indicated that several deaths have been associated with the use of mite extracts. The CBER was subsequently informed that these deaths may have been related to use by physicians or other health professionals untrained in the administration of potent allergens rather than a product defect. It should be noted that anaphylaxis and deaths following the injection of mite extracts have also been reported by the British Committee on Safety in Medicine in the British Medical Journal, V293,pp948,1986.
Local reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions steroids may be helpful.
What should I look out for while using Standardized Mite Dermatophagoides farinae?
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.
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.
What might happen if I take too much Standardized Mite Dermatophagoides farinae?
Overdose can cause both local and systemic reactions. Overdose is prevented by careful observation and questioning of the patient about the previous injection.
The treatment of systemic allergic reactions is dependent upon the symptom complex. In cases of an occurrence of a systemic or anaphylactic reaction, apply a tourniquet above the site of injection and inject intramuscularly or subcutaneously 0.3 to 0.5mL of 1:1000 Epinephrine Hydrochloride into the opposite arm. The dose may be repeated in 5-10 minutes if necessary. Loosen the tourniquet at least every 10 minutes. The Epinephrine Hydrochloride 1:1000 dose for infants to 2 years is 0.05 to 0.1 mL: for children 2 to 6 years it is 0.15 mL:, for children 6-12 years it is 0.2 mL.
Patients unresponsive to Epinephrine may be treated with Theophylline. Studies on asthmatic subjects reveal that plasma concentrations of Theophylline of 5 to 20 µg/mL are associated with therapeutic effects. Toxicity is particularly apparent at concentrations greater than 20 µg/mL. A loading dose of Aminophylline of 5.8 mg/kg intravenously followed by 0.9 mg/kg per hour results in plasma concentrations of approximately 10 µg/mL. (Mitenko and Ogilive, Nicholoson and Chick,1973)
Other beta-adrenergic drugs such as Isoproterenol, Isoetharine, or Albuterol may be used by inhalation. The usual dose to relieve broncho-constriction in asthma is 0.5 mL or the 0.5% solution for Isoproterenol HCl. The Albuterol inhaler delivers approximately 90 mcg of Albuterol from the mouthpiece. The usual dosage for adults and children would be two inhalations repeated every 4-6 hours. Isoetharine supplied in the Bronkometer unit delivers approximately 340 mcg Isoetharine. The average dose is one to two inhalations.
Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require Theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously.
Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Persistent wheezing may necessitate intravenous aminophylline treatment. For profound shock and hypotension, intravenous fluids, vasopressor and oxygen may also be needed. Maintenance of a patent airway is critical if upper and lower airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.
How should I store and handle Standardized Mite Dermatophagoides farinae?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Diagnostic Allergens-Intradermal test-Therapeutic allergens -Dilution's of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.Diagnostic Allergens-Intradermal test-Therapeutic allergens -Dilution's of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.Diagnostic Allergens-Intradermal test-Therapeutic allergens -Dilution's of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.Diagnostic Allergens-Intradermal test-Therapeutic allergens -Dilution's of concentrate can be made with either buffered diluent with 0.4% phenol or 50% glycerin (v/v) with salts.
Clinical Information
Chemical Structure
No Image foundClinical 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. 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.
Non-Clinical Toxicology
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.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.
Drug Interactions:
It has been reported that ZYLOPRIM prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when ZYLOPRIM is given to patients already on dicumarol therapy.
Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and ZYLOPRIM has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with ZYLOPRIM alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on ZYLOPRIM alone or in combination with uricosuric agents, the possibility should be kept in mind.
The reports that the concomitant use of ZYLOPRIM and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of ZYLOPRIM was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and ZYLOPRIM even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with ZYLOPRIM compared to patients who are not receiving both drugs. The cause of the reported association has not been established.
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of ZYLOPRIM. However, in a well-controlled study of patients with lymphoma on combination therapy, ZYLOPRIM did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.
Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.
Chlorpropamide's plasma half-life may be prolonged by ZYLOPRIM, since ZYLOPRIM and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if ZYLOPRIM and chlorpropamide are given concomitantly in the presence of renal insufficiency.
Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with ZYLOPRIM. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.
General Information:
Epinephrine 1:1000 should be available as well as personnel trained in administering emergency treatment.
To reduce the risk of an occurrence of adverse reactions, begin with a careful personal history plus a physical exam. Confirm your findings with scratch or intradermal skin testing. Patients should be observed for 30 minutes after any test.
Information for Patients:
Drug Interaction:
Carcinogenesis, mutagenesis, impairment of fertility.
Long term studies in animals have not been conducted with allergenic extracts, especially mite extracts, to determine their potential carcinogenicity, mutagenicity or impairment of fertility.
Pregnancy: Category C.
Nursing Mothers:
Pediatric Use:
Anaphylaxis and other systemic reactions may occur such as induced asthma, itching of nose and throat, breathlessness, urticaria and local reactions. Local reactions can be defined as an area of large erythema, swelling or pruritus at the injection site. Further indications of adverse reactions are edema, wheezing, dyspnea, locomotive impairment, marked perspiration, coughing, hypertension, shock and upper airway obstruction.
Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema and hypotension. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause shock and loss of consciousness. Fatalities have occurred rarely. These systemic reactions occur with varying frequency in different clinics. To some extent, the reaction rate is related to the type and dose of administered extract and to the degree of sensitivity of the patient. Despite all precautions, occasional reactions are unavoidable.
Reports from regulatory authorities in Sweden to the Center for Biologics Evaluation and Research (CBER) indicated that several deaths have been associated with the use of mite extracts. The CBER was subsequently informed that these deaths may have been related to use by physicians or other health professionals untrained in the administration of potent allergens rather than a product defect. It should be noted that anaphylaxis and deaths following the injection of mite extracts have also been reported by the British Committee on Safety in Medicine in the British Medical Journal, V293,pp948,1986.
Local reactions consisting of erythema, itching, swelling tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions steroids may be helpful.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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