Allergen Pack Cat Dander Solution Recall
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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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FDA Safety Alerts
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FDA Labeling Changes
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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)
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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.