Standardized Mite D. Farinae
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Questions & Answers
Side Effects & Adverse Reactions
See warnings at the beginning of this package insert. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract.
A reduction in starting dose is recommended in the following circumstances:
- Changing to a new lot of extract from the same manufacturer
- Using product from a different manufacturer
- Using non-standardized extract or any other change in formula
- Changing to a product bearing a later expiration date
- When a prolonged lapse in time has occurred since the last injection
Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:
- Severe rhinitis or asthma symptoms;
- Infection or flu accompanied by fever;
- Exposure to excessive amounts of clinically relevant allergen prior to therapy.
Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level. When switching one standardized extract with another, at least 75% reduction in dose is suggested.
Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstructions, hypotension and coma, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation. DO NOT GIVE INTRAVENOUSLY.
Mite Extracts (D. farinae and/or D. pteronyssinus) contain small (<1%) amounts of residual media components (pork and yeast). The physician should proceed with caution when using mite extract in mite sensitive individuals that also demonstrate sensitivity to these media components and only if clearly warranted.
In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with allergenic extract injections.
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.
Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.
Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.
History
There is currently no drug history available for this drug.
Other Information
Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus), used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material.
Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 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 also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive.
In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract.
For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter.
This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy.
In addition to the total allergen activity as described above, each Lot of Mite Extract @ 10,000 AU/mL is tested for two important specific allergens, Group I and Group II (Der f 1; Der p 1 and Der 2) (12, 13, 14, 15, 16, 17) by sandwich ELISA (18, 19, 20, 21, 22) .
Specific Lot values of these allergens are available from ALK-Abelló, Inc. by calling the Scientific Affairs Department.
Phone # 866-255-7722 or fax # 888-329-2551
The tables below provide summary data of released lots including coefficient of variation (% CV), range (min and max), and ratios on lots manufactured from 2002 through 2006.
| Der f 1 | Der 2 | 1+2 | Ratio 1:2 | |
| Average | 67 | 89 | 156 | 0.76 |
| % CV | 36 | 27 | 29 | 22 |
| Min | 21 | 51 | 90 | 0.26 |
| Max | 140 | 141 | 281 | 0.99 |
| Der p 1 | Der 2 | 1+2 | Ratio 1:2 | |
| Average | 67 | 69 | 136 | 0.97 |
| % CV | 27 | 22 | 23 | 16 |
| Min | 41 | 45 | 90 | 0.70 |
| Max | 98 | 104 | 184 | 1.27 |
| Der f 1 | Der p 1 | Der 2 | 1+2 | Ratio 1:2 | |
| Average | 34 | 34 | 79 | 146 | 0.87 |
| % CV | 31 | 27 | 21 | 19 | 15 |
| Min | 21 | 21 | 49 | 98 | 0.61 |
| Max | 58 | 46 | 106 | 203 | 1.11 |
| Ratio max/min | 2.8 | 2.2 | 2.1 | 2.1 | 1.8 |
Sources
Standardized Mite D. Farinae Manufacturers
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Alk-abello, Inc.
![Standardized Mite D. Farinae Injection, Solution Standardized Mite D. Farinae Solution Standardized Mite D. Pteronyssinus Injection, Solution [Alk-abello, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Mite D. Farinae | Alk-abello, Inc.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
When diluting bulk extracts, use of either Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly 10 fold dilutions are used to achieve a desired concentration for intradermal testing or initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 AU/mL extract into 4.5 mL of diluent will yield 5 mL of extract @ 1,000 AU/mL. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.
Care should be exercised to avoid cross contamination of allergens if mixing with other allergenic extracts. The use of separate syringes for each allergen and diluent when compounding patient mixes is recommended.
Diagnosis - In diagnosing the sensitive individual, the symptom history must be associated with exposure to the allergen. Skin testing is used in conjunction with a definitive history for diagnosing individual sensitivities.
An excellent method of recording results is to cover the skin reaction with transparent tape, outline the erythema first then the wheal with an indelible pen, then remove the tape and transfer it to the patient's permanent record. For preferred results, it is recommended that the actual measurement of the extent of both responses be recorded. This can be accomplished by measuring the longest erythema diameter, then selecting the mid - point of that line and measuring at a 90o angle to that line to determine the orthogonal diameter. The sum of these two measurements is the sum of erythema (∑E); the sum of wheal diameters is determined in a similar manner.
Patient's response is graded on the basis of the size of erythema and/or wheal.
Percutaneous (prick/scratch/puncture) test:
Prick, scratch, or puncture skin tests should be performed initially using an extract specially made for this purpose. The usual dose is one drop.
In a skin test study of 10 patients who were determined to be allergic to mite (D. farinae), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 73 mm (range 43 - 138 mm) and a sum of wheal of 17 mm (range 7 - 31 mm).
In another skin test study of 11 patients who were determined to be allergic to mite (D. pteronyssinus), the mean puncture test (using a bifurcated needle) to a solution containing 10,000 AU/mL had a sum of erythema of 84 mm (range 56 - 112 mm) and a sum of wheal of 20 mm (range 7 - 33 mm).
What follows are general guidelines for percutaneous testing. Different devices and/or techniques influence the size of the reaction, therefore it is important to refer to the device manufacturer's or distributor's instructions when grading reactions.
0 No wheal. Erythema absent or very slight (not more than 1 mm in diameter). + Wheal absent or very slight erythema present (not more than 3 mm diameter). ++ Wheal not more than 3 mm diameter, or erythema not more than 5 mm diameter. +++ Wheal between 3 mm and 5 mm in diameter with erythema. Possible pseudopodia and itching. ++++ Any larger reaction with itching and possible pain.Intradermal test:
On the forearm or upper outer aspect of the arm, using a 26 - 27 gauge, short bevel needle, inject intradermally .05 mL of the intradermal test solution. Skin whealing responses should be observed 10 - 20 minutes after administering the test.
In a skin test study of the 10 mite puncture reactive patients (D. farinae) described above, the mean intradermal dose for ∑E = 50 mm was 0.01 AU/mL ( range = <0.0003 to 0.4 AU/mL).
In the skin test study of the 11 mite puncture reactive patients (D. pteronyssinus) described above, the mean intradermal dose for ∑E = 50 mm was 0.006 AU/mL ( range = <0.0007 to 0.05 AU/mL).
Intradermal testing should start with a dilute solution, usually in the range of 1 AU or less.
Glycerinated extracts diluted for intradermal testing may be diluted at least 25 fold to less than 2% glycerin (by volume) as glycerin above this level can cause false positive intradermal skin tests.
A negative skin test is one where the sum of erythema was 0 or equal to the sum of the wheal. As a negative control, the diluent should be tested and included in the interpretation of the skin reactions.
0 No increase in size of bleb since injection. No erythema. + An increase in size of bleb and a wheal not more than 5 mm diameter with associated erythema. ++ Wheal between 5 mm and 8 mm in diameter with erythema. +++ Wheal between 8 mm and 12 mm in diameter with erythema and possible pseudopodia, itching or pain. ++++ Any larger reaction with itching and pain and possible diffuse blush of the skin surrounding the reaction area.Immunotherapy - Starting dose for immunotherapy is related directly to a patient's sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D50 (the intradermal dose, base three, that produces a ∑E = 50 mm).1
A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction). For example, if a patient exhibits a 2+ intradermal reaction to
1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed. (See beginning of DOSAGE AND ADMINISTRATION section for instructions in preparing dilutions of concentrates.)
If a tolerated dose of allergenic extract has been established, the initial dose from the new extract should be reduced by 75% of the previously well tolerated dose (see also Precautions).
Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month. The progress of patients on immunotherapy should be closely monitored. If improvement is realized a usual course of treatment may be from 3 to 5 years. If progress is unsatisfactory for a year or more, discontinuation of immunotherapy should be considered.
Injections are given subcutaneously preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.
After inserting the needle, but before injecting the dose, pull plunger of the syringe slightly, if blood returns in the syringe, discard the syringe and contents and repeat injection at another site.
Bulk concentrated extracts must be diluted for initial therapy and intradermal skin testing. For recommended diluent, refer to the beginning of the DOSAGE AND ADMINISTRATION section.
Use standard aseptic precautions when making dilutions. The first dose of the new extract should be reduced at least 50% - 75% of the amount of the dosage from the previous extract.
Stability studies for diluted and undiluted forms of this product are not complete. Indications are the undiluted product will retain its potency under recommended storage conditions at least until the expiration date on the vial label is reached. It is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time, i.e., preferably not more than four weeks.
HOW SUPPLIED
For percutaneous testing, 5 mL vial, 10,000 AU/mL in glycerin 50% (V/V).
For immunotherapy, 10 mL, 30 mL and 50 mL vials of bulk concentrate, 10,000 AU/mL in glycerin 50% (V/V).
STORAGE:To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2o to 8o C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.
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