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Felis Domesticus Hair
Overview
What is Standardized Cat Hair?
The standardized (BAU/ml) extract in these vials is designed primarily for the physician equipped to prepare dilutions and mixtures as required. The sterile extract is prepared from the extractables of cat hair and cat wash and contains 50% (v/v) glycerin as a preservative. It is intended for subcutaneous injection.
The cat hair extract is assayed for potency using Radial immunodiffusion (1) against a reference extract distributed by the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. Cat hair extract containing between 10-19.9 Fel d 1 U/ml are labeled 10,000 BAU/ml based on the quantitative skin testing (ID EAL Method) (2). Standardized cat hair is compared to a FDA reference cat hair extract by IEF to establish identity.
What does Standardized Cat Hair look like?
What are the available doses of Standardized Cat Hair?
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What should I talk to my health care provider before I take Standardized Cat Hair?
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How should I use Standardized Cat Hair?
Standardized Cat Hair Extracts are indicated for the diagnosis of patients with a history of allergy to cats and for treatment of patients with cat allergy. Diagnosis of allergic disease to cat hair is made through a combined medical history sufficiently complete to identify allergic symptoms to cat hair and identification of cat allergy by diagnostic skin testing.
Hyposensitization therapy is a treatment for patients exhibiting allergic reactions to cat. Immunotherapy is intended for patients whose symptoms cannot be satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. (5)
DIAGNOSTIC SKIN TESTING:
Puncture tests performed on 10 highly sensitive patients with 10,000 BAU/ml Cat Hair Extract showed a mean sum of diameter wheal of 17.00mm ± 4.59 and a mean sum of diameter Erythema of 71.60 +14.01.
Intradermal skin test results in highly sensitive patients is shown below using the same extract as used in the puncture test above.
These products are used to determine a patient's sensitivity to specific antigens and aid in the diagnosis and treatment of atopic diseases. After a thorough history a decision can be made as to which allergens will be appropriate to use for testing. The recommended procedure is to initially perform puncture tests, then follow with intradermal tests. See recommended dosage below.
What interacts with Standardized Cat Hair?
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What are the warnings of Standardized Cat Hair?
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What are the precautions of Standardized Cat Hair?
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What are the side effects of Standardized Cat Hair?
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What should I look out for while using Standardized Cat Hair?
There are no known absolute contraindications to hyposensitization therapy. See precautions section for pregnancy risks.
A patient should not be treated with allergens unless a history of symptoms and a positive skin test reaction have been demonstrated. Allergenic extracts should only be administered to patients that show symptoms of allergy or asthma. The physician must determine if the benefits outweigh the risks in using these products for treating these patients.
Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
See WARNING at the beginning of the instruction sheet.
Extracts standardized using the Bioequivalent Allergy Unit (BAU/ml) may be more potent than extracts based on weight to volume, or PNU methods. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. DO NOT GIVE ALLERGY INJECTIONS INTRAVENOUSLY. Subcutaneous injections are recommended. Injections may produce large local reactions that may be painful to the patient. DO NOT GIVE FULL STRENGTH INJECTIONS UNTIL THE COMPARATIVE STRENGTH IS DETERMINED. After inserting the needle, but before injection of extract, withdraw the plunger slightly. If blood appears in the syringe, re-insert the needle at another site. Careful selection of dose and injection should prevent most systemic reactions.
What might happen if I take too much Standardized Cat Hair?
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How should I store and handle Standardized Cat Hair?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Bulk extract (stock concentrate) in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 10ml, 30ml, and 50ml vials. Scratch testing in 50% (v/v) glycerin containing 10,000 BAU/ml is supplied in 2ml dropper vials. Intradermal testing (aqueous) containing 100 BAU/ml is supplied in 5ml vials.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The allergic state is initiated by an immune response inducing B cells to produce IgE antibodies to specific allergens. IgE antibodies bind to surface receptors on mast cells and basophils. When antigens gain access to the immune system they react with the bound IgE. The reacting antigen to the surface bound IgE stimulates a number of chemical mediators to be released from the mast cells and basophils. These include histamine, Eosinophil Chemotactic Factor (ECF-A) and leukotrienes. These chemical mediators are pharmacologically active at low concentrations and are partially responsible for the biological manifestation of the allergic response. (3)
The mechanism by which immunotherapy achieves hyposensitization is not completely understood. There is an increase in 'blocking antibody" (IgG) titer and in some patients a decrease in specific IgE, a decrease in histamine release to specific allergen and an increase in suppressor cell population to specific allergen. These changes may occur only after prolonged therapy. (4)
Non-Clinical Toxicology
There are no known absolute contraindications to hyposensitization therapy. See precautions section for pregnancy risks.A patient should not be treated with allergens unless a history of symptoms and a positive skin test reaction have been demonstrated. Allergenic extracts should only be administered to patients that show symptoms of allergy or asthma. The physician must determine if the benefits outweigh the risks in using these products for treating these patients.
Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
See WARNING at the beginning of the instruction sheet.
Extracts standardized using the Bioequivalent Allergy Unit (BAU/ml) may be more potent than extracts based on weight to volume, or PNU methods. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. DO NOT GIVE ALLERGY INJECTIONS INTRAVENOUSLY. Subcutaneous injections are recommended. Injections may produce large local reactions that may be painful to the patient. DO NOT GIVE FULL STRENGTH INJECTIONS UNTIL THE COMPARATIVE STRENGTH IS DETERMINED. After inserting the needle, but before injection of extract, withdraw the plunger slightly. If blood appears in the syringe, re-insert the needle at another site. Careful selection of dose and injection should prevent most systemic reactions.
Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Antihistamines can significantly inhibit the immediate skin test reactions. Patients should be free of such medication for at least 48 hours before testing.
The dosage should be reduced 50-75% from the previous dose when starting a patient on a new lot of standardized cat hair extract from the same manufacturer or from a different manufacturer. When changing from a non-standardized cat hair extract to a standardized cat hair extract, the dose should be based upon comparative skin testing or the patient should be treated as though beginning treatment for the first time.
A separate sterile tuberculin type syringe should be used with each patient to prevent cross contamination of extracts. This will also prevent transmission of disease such as serum hepatitis, AIDS and other infectious diseases. Aseptic technique should always be used when injections of allergenic extracts are administered.
Local reactions:
Some swelling and redness at the site of injection is not unusual. Mild burning that occurs immediately after the injection is normal; this usually subsides in 10 to 20 seconds. If the swelling and redness persist for a period of 24 hours or longer this should be a sign to proceed with caution in increasing the dosage. With the next injection the dosage should remain the same or be decreased. Large local reactions may indicate that a systemic reaction could occur with the next injection if the dosage was increased. If a patient continues to have reactions at the maintenance dose, the patient is considered to have exceeded the maximum tolerated dosage.
Systemic Reactions:
Systemic reactions occur infrequently but must be looked for in all patients, especially highly sensitive patients. Anaphylactic shock and death are always possible. Therefore, physicians must be prepared for the treatment of these reactions. Systemic reactions can also be characterized by one or more of the following symptoms: angioedema, tachycardia, conjunctivitis, cough, fainting, hypotension, pallor, rhinitis, urticaria, and wheezing.
Systemic reaction can be treated by the immediate application of a tourniquet above the site of injection and the administration of 0.3 to 0.5ml of 1:1000 Epinephrine - Hydrochloride subcutaneously or intramuscularly at the site of allergen injection. The dosage may be repeated two times at 15 minute intervals. Loosen the tourniquet at least every 10 minutes.
The pediatric dosage for 1:1000 Epinephrine-Hydrochloride is 0.05 to 0.1ml for infants to 2 years of age; 0.15ml, for children 2 to 6 years; and 0.2ml, for children 6 to 12 years.
Patients should always be observed for at least 30 minutes after any injection. Hypotension can be reversed by using vasopressor agents and volume expanders. Parenteral aminophylline and inhalation bronchodilators may be required for bronchospasm. Oxygen may also be needed. Maintenance of an open airway is critical if upper airway obstruction is present. Adrenal corticosteroids and intravenous antihistamine can be given after adequate epinephrine and circulatory support has been administered. Physicians must be familiar with these systemic reactions and have all the equipment and drugs necessary for proper treatment. (7)
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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