House Dust Mite, Dermatophagoides farinae 10000 [AU]/mL
House Dust Mite, Dermatophagoides farinae · INJECTION · Allermed Laboratories, Inc.
House Dust Mite, Dermatophagoides farinae is a injection containing house dust mite, dermatophagoides farinae at 10000 [AU]/mL, taken cutaneous. Manufactured by Allermed Laboratories, Inc..
Key Facts
- Brand Name
- House Dust Mite, Dermatophagoides farinae
- Generic Name
- House Dust Mite, Dermatophagoides farinae
- NDC Code (Product)
49643-702- Manufacturer
- Allermed Laboratories, Inc.
- Strength
- 10000 [AU]/mL
- Dosage Form
- INJECTION
- Route
- CUTANEOUS, INTRADERMAL, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA102212
- Drug Class
- Standardized Insect Allergenic Extract [EPC]
- Marketing Start
- 12/24/1986
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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).
Dosage & Administration
DOSAGE AND ADMINISTRATION 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. DIAGNOSTIC USE: Percutaneous Tests : 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. Intradermal Tests : 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: Table 1 AU/mL to elicit 50 mm sum of diameter erythema reaction Allergen No. of Persons Mean Range D. farinae 5 0.0040 0.0013-0.0124 D. pteronyssinus 10 0.0031 0.00…
Warnings
WARNINGS 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 …
Contraindications
CONTRAINDICATIONS Injections of mite extract should not be administered in the presence of diseases characterized by a bleeding diathesis. Immunotherapy should not be started in patients until a specific diagnosis of Type I allergy to mite is made by a physician based on skin testing with this product. Other contraindications include: EXTREME SENSITIVITY TO MITE: Determined from previous anaphylaxis following skin testing, immunotherapy, or natural exposure. AUTOIMMUNE DISEASE: Individuals with autoimmune disease maybe at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease. MYOCARDIAL INFARCTION: Patients who have experienced a recent myocardial infarction may not be able to tolerate immunotherapy. The benefit-to-risk ratio must be carefully evaluated. CHILDREN WITH NEPHROTIC SYNDROME: Children with nephrotic syndrome require careful consideration and probably should not receive immunotherapy due to a variety of seemingly unrelated events that may cause an exacerbation of nephrotic disease.
Adverse Reactions
ADVERSE REACTIONS 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 (11). 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. 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 and other extracts also hav…
Frequently Asked Questions
What is House Dust Mite, Dermatophagoides farinae used for?
House Dust Mite, Dermatophagoides farinae contains House Dust Mite, Dermatophagoides farinae. It is a injection taken cutaneous. Consult your doctor for specific uses.
Is House Dust Mite, Dermatophagoides farinae a controlled substance?
House Dust Mite, Dermatophagoides farinae is not classified as a controlled substance by the DEA.
What is the generic name for House Dust Mite, Dermatophagoides farinae?
The generic name for House Dust Mite, Dermatophagoides farinae is House Dust Mite, Dermatophagoides farinae. There are no other listed brand versions of House Dust Mite, Dermatophagoides farinae.
What is the NDC code for House Dust Mite, Dermatophagoides farinae 10000 [AU]/mL?
The NDC (National Drug Code) for House Dust Mite, Dermatophagoides farinae 10000 [AU]/mL is 49643-702, listed by Allermed Laboratories, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)