Allergen Pack Cat Dander Solution
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Questions & Answers
Side Effects & Adverse Reactions
Please also refer to warning box at beginning of package insert.
Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for immunotherapy or intradermal testing. All concentrates of allergenic extracts are manufactured to assure high potency and therefore have the ability during skin testing and immunotherapy to cause serious local and systemic reactions including death in sensitive patients. Most reactions occur within 20 minutes after injection,(18) but may occur later.(19) To minimize the potential for local or systemic reactions, the relative sensitivity of the patient must be assessed from the allergic history and from clinical observations. Patients should be informed of this and the precautions should be discussed prior to immunotherapy (see PRECAUTIONS below).
Standardized Cat Hair Extract labeled in Bioequivalent Allergy Units is not interchangeable with Standardized Cat Pelt Extract or with cat extracts labeled in Allergy Units. Patient doses stated or calculated in Allergy Units should not be confused with Bioequivalent Allergy Units because the BAU is ten times as potent as the Allergy Unit used for cat extracts before September 1992.
The dosage must be reduced when starting a patient on fresh Standardized Cat Hair Extract or when transferring a patient from any other cat extract product to Standardized Cat Hair Extract (even though the labeled strength of the old and new vials may be the same). This reduction in dosage may be necessary due to a loss of extract potency during storage in the physician's office. The cat allergen content of old and new extracts must be compared and adjusted by dosage reduction and/or dilution before the new extract is administered. The amount of new extract given should not exceed 25% of the last dose given from the old vial, assuming both extracts contain comparable amounts of cat allergens. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Allergenic extracts 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.
Risk of anaphylaxis should be weighed against benefits of immunotherapy: in patients receiving beta blockers as they may not be responsive to beta adrenergic drugs should anaphylaxis occur; in patients with unstable or steroid-dependent asthma; or in patients with cardiovascular disease.
Not for intravenous use!
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Standardized Cat Hair Extract is indicated for the diagnosis and treatment (immunotherapy) of patients with a history of allergy to cats. The diagnosis of cat allergy is established by the allergy history, clinical evaluation, and skin test reactivity. Cat emanations are common causes of allergy and occur not only upon direct exposure to cats, but also occur in high levels in house dust and other environmental dusts.(17) Persons suspected of having allergy to house dust should be tested for sensitivity to cat allergens. Immunotherapy is indicated when cat allergy is established and the patient cannot avoid exposure to cat allergens.
The use of cat extract for the above purposes should be made only by physicians with special familiarity with and knowledge of allergy. (SEE DOSAGE AND ADMINISTRATION)
History
There is currently no drug history available for this drug.
Other Information
Each vial contains a sterile extract of cat (Felis domesticus) pelt and cat dander, 0.50% sodium chloride, 0.25% sodium bicarbonate, 50% glycerin by volume, and 0.4% phenol as a preservative. Source materials for the extract are dry cat dander and dry defatted cat pelt.
Standardized Cat Hair Extract is a sterile solution for intracutaneous or subcutaneous administration. The extract is standardized by comparing potency in cat allergen 1 (Fel d I) units measured by radial immunodiffusion against a referencestandard from the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA).(1-3) An extract with 10 to 19.9 Fel d I units per mL is designated as 10,000 Bioequivalent Allergy Units/mL (BAU/mL) by the FDA based on quantitative skin testing.(2) Greer Standardized Cat Hair Extract concentrate is 10,000 BAU/mL.
Cat albumin is considered to be a minor allergen, but may be significant for certain patients.(4) Fel d I is a relatively stable component while albumin is more labile and more easily destroyed by heat.(5-6) For lot release, Standardized Cat Hair Extract is compared to FDA reference by isoelectric focusing (IEF) to differentiate it from Cat Pelt Extract.
Sources
Allergen Pack Cat Dander Solution Manufacturers
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Alvix Laboratories, Llc
![Allergen Pack Cat Dander Solution [Alvix Laboratories, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Allergen Pack Cat Dander Solution | Alvix Laboratories, Llc
GeneralConcentrated standardized cat hair extracts should be diluted prior to intradermal testing or first use in immunotherapy.
Diagnostic Testing
Normal or buffered saline or normal saline with human serum albumin may be used to prepare appropriate dilutions. Vials should be visually inspected to ensure particulate free prior to use.For the patient with a suspected diagnosis of cat allergy, initial testing may be conducted with the concentrate by means of a puncture test employing a multiple puncture device or other appropriate instrument. Prick testing through a drop of extract or scratch testing with a drop of extract applied to the scratch may also be employed to
determine the degree of sensitivity. If the response is negative, this initial test may be followed by intradermal testing where the clinical history is strongly indicative of allergy to cats. Use of a positive and negative control is recommended.The most frequently used test sites are the back and the volar surface of the forearms. The skin should be cleansed with alcohol and allowed to dry. A minimum of at least 1 inch should be allowed between test sites. A marking pencil may be used to indicate the site locations.
Puncture, Prick or Scratch Testing
Skin tests read after 15 to 20 minutes are graded in terms of the induration (wheal) and erythema (flare) response compared to the appropriate controls. Wheal and flare sizes may be recorded by actual measurements. The largest diameter of the wheal and flare may be recorded, or the sum of the largest diameter and the orthogonal (right angle) diameter wheal or flare may be used.The skin test concentration of 10,000 BAU/mL is used for puncture, prick or scratch testing. Puncture tests with Standardized Cat Hair Extract performed on ten highly sensitive cat puncture-positive patients showed a mean diameter wheal of 6.0 mm ± 2.2 mm and a mean erythema of 36.7 mm ± 6.7 mm. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1000 w/v) may be used as a positive control. A 50% glycerosaline solution may be used as the negative control.
A sterile puncture device, needle, scalpel blade, or scarifier is used. A separate sterile device must be used for each patient to prevent transmission of infectious agents. If the device contacts extracts, use a separate device for each antigen to prevent cross-contamination.
Intradermal Testing
The skin is abraded only enough to enter the dermis without drawing blood. Follow the directions for the device being used. The antigen may be applied directly with a puncture device or is introduced by applying a drop of extract to the scratch or prick site, taking care not to touch the skin with the dropper tip.Extract for intradermal testing must be prepared by diluting the stock concentrate with sterile diluent (use normal or buffered saline or normal saline with human serum albumin) or obtained by ordering the appropriate dilutions ready made. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). As a negative control, use 0.5% to 1% glycerosaline solution.
Table I: BAU/mL to Elicit 50mm Sum of Diameter Erythema Reaction Geometric Mean Range 0.0542 0.0050 - 0.4809
Intradermal skin tests with 0.05 mL of three-fold serial dilutions in ten highly sensitive cat puncture test positive (sum of erythema >57 mm) persons showed the results in Table I:Intradermal extract is used as follows:
a. Patients with a negative scratch or prick-puncture test:Patients who do not react to a scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 50 BAU/mL extract dilution. If this test is negative, a second intradermal test may be performed using a 200 BAU/mL extract dilution.
b. Patients tested only by the intradermal method:
Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded and the dose adjusted according to puncture test reactivity. Other patients suspected of being moderately allergic may be tested with an intradermal test dose of 0.02 to 0.05 mL of a 0.05 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 200 BAU/mL is reached.
Immunotherapy
Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.Immunotherapy is administered by subcutaneous injection. Not for intravenous use!
Dosage of allergenic extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The initial dose of the extract should be calculated based on the puncture test reactivity. The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (dilution 5 or 6 in Table II below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution. The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount; the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of 5,000 BAU/mL may cause discomfort upon injection because of the high glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment.To prepare dilutions for intradermal and therapeutic use starting from a 5,000 or 10,000 BAU/mL stock concentrate proceed as follows: (Note add 1 mL of concentrate to 9.0 mL of sterile diluent and make additional dilutions in the same manner.)
Table II Dilution Extract Diluent BAU/mL 0 Concentrate 9.0 5,000 10,000 1 1 mL concentrate 9.0 500 1,000 2 1 mL dilution 1 9.0 50 100 3 1 mL dilution 2 9.0 5 10 4 1 mL dilution 3 9.0 0.5 1.0 5 1 mL dilution 4 9.0 0.05 0.1 6 1 mL dilution 5 9.0 0.005 0.01The optimal interval between doses of allergenic extract has not been definitely established. However, as is customarily practiced, injections are given 1, 2 or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval is increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made depending on a consideration of the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter of the previous dose.
GeneralConcentrated standardized cat hair extracts should be diluted prior to intradermal testing or first use in immunotherapy.
Diagnostic Testing
Normal or buffered saline or normal saline with human serum albumin may be used to prepare appropriate dilutions. Vials should be visually inspected to ensure particulate free prior to use.For the patient with a suspected diagnosis of cat allergy, initial testing may be conducted with the concentrate by means of a puncture test employing a multiple puncture device or other appropriate instrument. Prick testing through a drop of extract or scratch testing with a drop of extract applied to the scratch may also be employed to
determine the degree of sensitivity. If the response is negative, this initial test may be followed by intradermal testing where the clinical history is strongly indicative of allergy to cats. Use of a positive and negative control is recommended.The most frequently used test sites are the back and the volar surface of the forearms. The skin should be cleansed with alcohol and allowed to dry. A minimum of at least 1 inch should be allowed between test sites. A marking pencil may be used to indicate the site locations.
Puncture, Prick or Scratch Testing
Skin tests read after 15 to 20 minutes are graded in terms of the induration (wheal) and erythema (flare) response compared to the appropriate controls. Wheal and flare sizes may be recorded by actual measurements. The largest diameter of the wheal and flare may be recorded, or the sum of the largest diameter and the orthogonal (right angle) diameter wheal or flare may be used.The skin test concentration of 10,000 BAU/mL is used for puncture, prick or scratch testing. Puncture tests with Standardized Cat Hair Extract performed on ten highly sensitive cat puncture-positive patients showed a mean diameter wheal of 6.0 mm ± 2.2 mm and a mean erythema of 36.7 mm ± 6.7 mm. Glycerinated histamine phosphate 5 mg/mL (1.8 mg/mL histamine base) or aqueous histamine phosphate 2.75 mg/mL (1 mg/mL histamine base; 1:1000 w/v) may be used as a positive control. A 50% glycerosaline solution may be used as the negative control.
A sterile puncture device, needle, scalpel blade, or scarifier is used. A separate sterile device must be used for each patient to prevent transmission of infectious agents. If the device contacts extracts, use a separate device for each antigen to prevent cross-contamination.
Intradermal Testing
The skin is abraded only enough to enter the dermis without drawing blood. Follow the directions for the device being used. The antigen may be applied directly with a puncture device or is introduced by applying a drop of extract to the scratch or prick site, taking care not to touch the skin with the dropper tip.Extract for intradermal testing must be prepared by diluting the stock concentrate with sterile diluent (use normal or buffered saline or normal saline with human serum albumin) or obtained by ordering the appropriate dilutions ready made. As a positive control, use glycerinated histamine phosphate diluted to 0.5 mg/mL (0.18 mg/mL histamine base) or aqueous histamine phosphate 0.275 mg/mL (0.1 mg/mL histamine base). As a negative control, use 0.5% to 1% glycerosaline solution.
Table I: BAU/mL to Elicit 50mm Sum of Diameter Erythema Reaction Geometric Mean Range 0.0542 0.0050 - 0.4809
Intradermal skin tests with 0.05 mL of three-fold serial dilutions in ten highly sensitive cat puncture test positive (sum of erythema >57 mm) persons showed the results in Table I:Intradermal extract is used as follows:
a. Patients with a negative scratch or prick-puncture test:Patients who do not react to a scratch or prick-puncture test should be tested intradermally with 0.02 to 0.05 mL of a 50 BAU/mL extract dilution. If this test is negative, a second intradermal test may be performed using a 200 BAU/mL extract dilution.
b. Patients tested only by the intradermal method:
Since highly reactive individuals may react intracutaneously at 1:1 million or even 1:10 million dilutions, any intradermal injection should be preceded and the dose adjusted according to puncture test reactivity. Other patients suspected of being moderately allergic may be tested with an intradermal test dose of 0.02 to 0.05 mL of a 0.05 BAU/mL dilution. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 200 BAU/mL is reached.
Immunotherapy
Skin tests are graded in terms of the wheal and erythema response noted at 15 to 20 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.Immunotherapy is administered by subcutaneous injection. Not for intravenous use!
Dosage of allergenic extracts is individualized according to the patient's sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The initial dose of the extract should be calculated based on the puncture test reactivity. The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (dilution 5 or 6 in Table II below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution. The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount; the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose. Any evidence of systemic reaction is an indication for a significant reduction (at least 50%) in the subsequent dose. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of 5,000 BAU/mL may cause discomfort upon injection because of the high glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment.To prepare dilutions for intradermal and therapeutic use starting from a 5,000 or 10,000 BAU/mL stock concentrate proceed as follows: (Note add 1 mL of concentrate to 9.0 mL of sterile diluent and make additional dilutions in the same manner.)
Table II Dilution Extract Diluent BAU/mL 0 Concentrate 9.0 5,000 10,000 1 1 mL concentrate 9.0 500 1,000 2 1 mL dilution 1 9.0 50 100 3 1 mL dilution 2 9.0 5 10 4 1 mL dilution 3 9.0 0.5 1.0 5 1 mL dilution 4 9.0 0.05 0.1 6 1 mL dilution 5 9.0 0.005 0.01The optimal interval between doses of allergenic extract has not been definitely established. However, as is customarily practiced, injections are given 1, 2 or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval is increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made depending on a consideration of the components and the patient's sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter of the previous dose.
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