Human Allergy Catalog - Greer

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WARNINGTHIS ALLERGENIC PRODUCT IS INTENDED FOR USE BY PHYSICIANS WHOARE EXPERIENCED IN THE ADMINISTRATION OF ALLERGENIC EXTRACTS ANDTHE EMERGENCY CARE OF ANAPHYLAXIS, OR FOR USE UNDER THEGUIDANCE OF AN ALLERGY SPECIALIST.STANDARDIZED CAT HAIR EXTRACT WITH POTENCY LABELING INBIOEQUIVALENT ALLERGY UNITS per mL (BAU/mL) IS NOT INTERCHANGEABLEWITH OTHER CAT EXTRACTS. STANDARDIZED CAT HAIR EXTRACT IS NOTINTERCHANGEABLE WITH STANDARDIZED CAT PELT EXTRACTS LABELED INBIOEQUIVALENT ALLERGY UNITS OR WITH OTHER CAT EXTRACTS LABELED INALLERGY UNITS (AU).THE INITIAL DOSE OF STANDARDIZED CAT HAIR EXTRACT MUST BE BASEDON SKIN TESTING AS DESCRIBED IN THE DOSAGE AND ADMINISTRATIONSECTION OF THIS INSERT. PATIENTS BEING SWITCHED FROM OTHER TYPESOF EXTRACTS TO STANDARDIZED CAT HAIR EXTRACT SHOULD BEINSTRUCTED TO RECOGNIZE ADVERSE REACTION SYMPTOMS ANDCAUTIONED TO CONTACT THE PHYSICIAN’S OFFICE IF REACTION SYMPTOMSOCCUR. IN CERTAIN INDIVIDUALS THESE REACTIONS COULD BE FATAL.PATIENTS SHOULD BE OBSERVED FOR AT LEAST 20 MINUTES FOLLOWINGIMMUNOTHERAPY. PATIENTS WITH LABILE OR STEROID-DEPENDENT ASTHMAARE “HIGH RISK PATIENTS” WHO REQUIRE SPECIAL CAUTION IN DOSEADMINISTRATION AND SHOULD REMAIN IN THE OFFICE FOR AT LEAST 30MINUTES. AIRWAY OBSTRUCTION IN HIGH RISK PATIENTS CAN BE MONITOREDBY PEAK FLOW MEASUREMENTS BEFORE AND AFTER ADMINISTRATION OFALLERGENS. EMERGENCY MEASURES AS WELL AS PERSONNEL TRAINED INTHEIR USE SHOULD BE IMMEDIATELY AVAILABLE IN THE EVENT OF A LIFETHREATENING REACTION. PATIENTS BEING SWITCHED FROM ONE LOT OFEXTRACT TO ANOTHER FROM THE SAME MANUFACTURER SHOULD HAVETHEIR DOSE REDUCED BY 75%.RISK OF ANAPHYLAXIS SHOULD BE WEIGHED AGAINST BENEFITS INIMMUNOTHERAPY: IN PATIENTS RECEIVING BETA BLOCKERS AS THEY MAYNOT BE RESPONSIVE TO BETA ADRENERGIC DRUGS SHOULD ANAPHYLAXISOCCUR; IN PATIENTS WITH UNSTABLE OR STEROID-DEPENDENT ASTHMA; ORIN PATIENTS WITH CARDIOVASCULAR DISEASE.THIS PRODUCT SHOULD NOT BE INJECTED INTRAVENOUSLY.REFER ALSO TO THE WARNINGS, PRECAUTIONS, ADVERSE REACTIONSAND OVERDOSAGE SECTION BELOW.DESCRIPTIONEach 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 drydefatted cat pelt.Standardized Cat Hair Extract is a sterile solution for intracutaneous orsubcutaneous administration. The extract is standardized by comparing potency in catallergen 1 (Fel d I) units measured by radial immunodiffusion against a reference
standard from the Center for Biologics Evaluation and Research of the U.S. Food andDrug Administration (FDA). (1-3) An extract with 10 to 19.9 Fel d I units per mL isdesignated as 10,000 Bioequivalent <strong>Allergy</strong> Units/mL (BAU/mL) by the FDA based onquantitative skin testing. (2) <strong>Greer</strong> Standardized Cat Hair Extract concentrate is10,000 BAU/mL.Cat albumin is considered to be a minor allergen, but may be significant for certainpatients. (4) Fel d I is a relatively stable component while albumin is more labile andmore easily destroyed by heat. (5-6) For lot release, Standardized Cat Hair Extract iscompared to FDA reference by isoelectric focusing (IEF) to differentiate it from Cat PeltExtract.CLINICAL PHARMACOLOGYThe allergic reaction is dependent upon the presence of antigen-specific IgEantibodies that are bound to specific receptors on mast cells and basophils and hasbeen demonstrated for cat-allergic individuals. (7) The presence of IgE antibodies onmast cells and basophils sensitizes these cells and upon interaction with theappropriate allergen-histamine and other mediators are released. (8) In the skin thesemediators are responsible for the characteristic wheal and flare reaction. (9)An increase in cat antigen-specific IgG antibodies has been demonstrated as aresult of immunotherapy. (10-11) The complete mechanisms of immunotherapy are notknown and are still under investigation.Immunotherapy with cat extract has been studied by several investigators. It isgenerally believed that hyposensitization with this product is helpful in reducing allergicsymptoms associated with exposure to cat allergens in homes or the environment. (12-16)INDICATIONS AND USAGEStandardized Cat Hair Extract is indicated for the diagnosis and treatment(immunotherapy) of patients with a history of allergy to cats. The diagnosis of catallergy 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 exposureto 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 catallergens. Immunotherapy is indicated when cat allergy is established and the patientcannot avoid exposure to cat allergens.The use of cat extract for the above purposes should be made only by physicianswith special familiarity with and knowledge of allergy. (SEE DOSAGE ANDADMINISTRATION)CONTRAINDICATIONSThere are no known absolute contraindications to the use of Allergenic Extracts forimmunotherapy. Immunotherapy with cat antigens is contraindicated in thoseindividuals who do not exhibit skin test or clinical sensitivity to cat antigens. (See belowunder WARNINGS AND PRECAUTIONS)Cat extract injections should not be administered in the presence of diseasescharacterized by a bleeding diathesis.
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Page 68 and 69: a 1:10 dilution by adding 0.5 mL of
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Page 72 and 73: DOSAGE AND ADMINISTRATIONA. Testing
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Human Allergy Catalog - Greer

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