Standardized Mite Mix Recall
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Questions & Answers
Side Effects & Adverse Reactions
See WARNINGS at the beginning of this instruction sheet.
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, or (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. Do not start immunotherapy during a period of symptoms due to exposure. Since the individual components of the extract are those to which the patient is allergic, and to which he or she will be exposed, typical allergic symptoms may follow shortly after the injection, particularly when the antigen load from exposure plus the injected antigen exceeds the patient's antigen tolerance.
INJECTIONS SHOULD NEVER BE GIVEN INTRAVENOUSLY. Subcutaneous injection is recommended. Intracutaneous or intramuscular injections may produce large local reactions or be excessively painful.
AFTER INSERTING NEEDLE SUBCUTANEOUSLY, BUT BEFORE INJECTING, ALWAYS WITHDRAW THE PLUNGER SLIGHTLY. IF BLOOD APPEARS IN THE SYRINGE, CHANGE NEEDLE AND GIVE THE INJECTION IN ANOTHER SITE. Proper selection of the dose and careful injection should prevent most systemic reactions. It must be remembered, however, that allergenic extracts are highly potent in sensitive individuals, and that systemic reactions of varying degrees of severity may occur, including urticaria, rhinitis, conjunctivitis, wheezing, coughing, angioedema, hypotension, bradycardia, pallor, laryngeal edema, fainting, or even anaphylactic shock and death. Patients should be informed of this, and the precautions should be discussed prior to immunotherapy. (See PRECAUTIONS below.) Severe systemic reactions should be treated as indicated in the ADVERSE REACTIONS Section.
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FDA Safety Alerts
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FDA Labeling Changes
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16, 17, 18, 26 Standardized glycerinated allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.
The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.
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Mite extract is a sterile solution containing the extractables of Dermatophagoides farinae or Dermatophagoides pteronyssinus, 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin by volume as a preservative. Source material for the extract is the whole bodies of the mites. The mites are grown on a medium of brine shrimp eggs and wheat germ, and are handled and cleaned in a manner that the maximum carryover of the medium components is less than 1%. The medium contains no material of human origin.
Sterile, diluted mite extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% albumin (human), not more than 0.003% sodium bicarbonate, and 0.4% phenol as a preservative.
Skin test trials were conducted to evaluate the skin reactivity of medium components mixed in the approximate proportion used for mite growth. Twenty-three individuals who were puncture test reactive (∑E≥40mm) to either D. farinae or D. pteronyssinus were tested with an extract of medium components at an estimated 1% carryover level. None of these patients had a ∑E response more than 3mm larger than the negative control by puncture test with the concentrate of the medium components extract. One of the 23 patients had a reaction with ∑E≥20mm when tested intradermally with a 1:100 (v/v) dilution of the concentrate of the medium components extracts.
Standardized D. farinae and D. pteronyssinus extract concentrates (stock concentrates) containing 30,000 Allergy Units/mL (AU/mL) are supplied in dropper vials for scratch, prick or puncture tests. Stock concentrates are also available in multiple-dose vials containing 10,000 AU/mL and 30,000 AU/mL to be diluted for intradermal testing and immunotherapy.
Standardized D. farinae and D. pteronyssinus extract dilutions (at 30 AU/mL and 300 AU/mL) are supplied for intradermal diagnostic tests described in Section DOSAGE AND ADMINISTRATION, Diagnosis, Part 2.a.
1. Allergy Units (AU/mL). The potency of extracts labeled in Allergy Units (AU/mL) is determined by in vitro comparison to a reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration.
2. Bioequivalent Allergy Units (BAU/mL).
Other standardized allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by in vitro assay or major allergen content) to CBER, FDA Reference Preparations. The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50, Bioequivalent Allergy Units are assigned as follows:
|50%||Short Ragweed 1:20 w/v|
|25%||Std Cat Hair 10,000 BAU/mL|
|25%||Std Mite D. farinae 10,000 AU/mL|
|Actual Allergen Strength In concentrate Mixture||=||Allergen Manufacturing Strength||X||% allergen in Formulation |
(by volume or parts)