Standardized Cat Hair
Generic: CAT HAIR
Basic Information
Manufacturer
Allermed Laboratories, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
CUTANEOUS
FDA Set ID
abffdafd-f922-44ab-8e98-972a72ca1004
Indications & Usage
INDICATIONS AND USAGE Studies have shown that skin tests with cat extract are useful in the diagnosis of cat allergy.
As a rule, persons with cat allergy have positive skin reactions when tested with cat extract, and non-allergic individuals rarely react (7, 8, 9).
However, the relationship between a positive skin test and the appearance of clinical symptoms after exposure to a cat is not absolute, i.e., some skin-test positive persons do not experience allergic symptoms after exposure (10).
Failure to experience symptoms may be dose related, since it is known that cats vary significantly in the amount of Fel d1 they produce (11).
The efficacy of cat extract immunotherapy in the treatment of bronchial asthma has been shown in two studies (12, 13) A reduction in bronchial sensitivity was observed in five patients with cat allergy, whereas no reduction was observed in placebo treated, cat-allergic patients.
As a rule, persons with cat allergy have positive skin reactions when tested with cat extract, and non-allergic individuals rarely react (7, 8, 9).
However, the relationship between a positive skin test and the appearance of clinical symptoms after exposure to a cat is not absolute, i.e., some skin-test positive persons do not experience allergic symptoms after exposure (10).
Failure to experience symptoms may be dose related, since it is known that cats vary significantly in the amount of Fel d1 they produce (11).
The efficacy of cat extract immunotherapy in the treatment of bronchial asthma has been shown in two studies (12, 13) A reduction in bronchial sensitivity was observed in five patients with cat allergy, whereas no reduction was observed in placebo treated, cat-allergic patients.
Warnings
WARNINGS Standardized Cat Hair Extract may cause local or severe life-threatening reactions when administered to highly sensitive individuals.
Physicians who use this product should be familiar with the clinical use of allergenic extract and have the necessary emergency equipment and medications available to treat systematic allergic reactions See Precautions, Adverse Reactions and Overdosage .
Standardized Cat Hair Extract should not be used interchangeably with Standardized Cat Pelt Extracts or previously standardized cat extracts labeled in Allergy Units per mL.
Cat hair extracts labeled in BAU/mL made by other manufacturers should be tested for bioequivalency by serial titration skin testing before these products are used in patients who have previously received Allermed Standardized Cat Hair Extract.
The dosage of Standardized Cat Hair Extract must be reduced when starting a patient on a new lot of Standardized Cat Hair Extract containing the same amount of Fel d1 units per mL.
This is necessary due to a possible loss of potency during storage in the physician's office.
The dose of the new lot of extract should not exceed 1/4 the last dose given from the old lot of extract.
Any evidence of a strong local reaction or systemic reaction following the administration of Standardized Cat Hair Extract requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Physicians who use this product should be familiar with the clinical use of allergenic extract and have the necessary emergency equipment and medications available to treat systematic allergic reactions See Precautions, Adverse Reactions and Overdosage .
Standardized Cat Hair Extract should not be used interchangeably with Standardized Cat Pelt Extracts or previously standardized cat extracts labeled in Allergy Units per mL.
Cat hair extracts labeled in BAU/mL made by other manufacturers should be tested for bioequivalency by serial titration skin testing before these products are used in patients who have previously received Allermed Standardized Cat Hair Extract.
The dosage of Standardized Cat Hair Extract must be reduced when starting a patient on a new lot of Standardized Cat Hair Extract containing the same amount of Fel d1 units per mL.
This is necessary due to a possible loss of potency during storage in the physician's office.
The dose of the new lot of extract should not exceed 1/4 the last dose given from the old lot of extract.
Any evidence of a strong local reaction or systemic reaction following the administration of Standardized Cat Hair Extract requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Adverse Reactions
ADVERSE REACTIONS Local Reactions From Skin Testing Large local reactions may result from skin tests with Standardized Cat Hair Extract.
To help prevent this, a patient should be skin tested initially by the prick or scratch method.
If a positive response is NOT observed, an intradermal skin test may be performed with a more dilute solution of the extract.
Oral antihistamines and topical corticosteroids may be administered to relieve itching and swelling resulting from large skin test reactions.
Local Reactions From Subcutaneous Injections The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract is usually due to leakage of extract into the skin along the needle tract.
Firm pressure (not rubbing) at the site of injection immediately after withdrawal of the needle will usually prevent this reaction.
It does not require a reduction in dosage.
However, a strong local reaction with erythema and edema which persists at the injection site for several hours indicates that too much extract has been given.
Failure to note this response may result in a serious generalized reaction.
Treatment should be altered as follows: Additional injections should not be given until all evidence of the reaction has disappeared.
The next injection administered should be 50% of the last nonreacting dose or less, depending upon the size and severity of the local reaction.
Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result from the administration of a larger dose of extract.
Systemic Reactions Systemic reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis.
The reaction usually occurs 5 to 20 minutes after injection.
As a rule, the more quickly a reaction develops, the more serious it is likely to become.
Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases.
The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below).
The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts.
In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheotomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.
To help prevent this, a patient should be skin tested initially by the prick or scratch method.
If a positive response is NOT observed, an intradermal skin test may be performed with a more dilute solution of the extract.
Oral antihistamines and topical corticosteroids may be administered to relieve itching and swelling resulting from large skin test reactions.
Local Reactions From Subcutaneous Injections The occurrence of a hive 5 to 15 minutes after the subcutaneous injection of extract is usually due to leakage of extract into the skin along the needle tract.
Firm pressure (not rubbing) at the site of injection immediately after withdrawal of the needle will usually prevent this reaction.
It does not require a reduction in dosage.
However, a strong local reaction with erythema and edema which persists at the injection site for several hours indicates that too much extract has been given.
Failure to note this response may result in a serious generalized reaction.
Treatment should be altered as follows: Additional injections should not be given until all evidence of the reaction has disappeared.
The next injection administered should be 50% of the last nonreacting dose or less, depending upon the size and severity of the local reaction.
Subsequent injections should be continued at the reduced dosage unless the physician responsible for treatment believes that it is safe to increase the dose, and that possible clinical improvement would result from the administration of a larger dose of extract.
Systemic Reactions Systemic reactions may range from a mild exacerbation of the patient's allergic symptoms to hives, anaphylactic shock, or even death from anaphylaxis.
The reaction usually occurs 5 to 20 minutes after injection.
As a rule, the more quickly a reaction develops, the more serious it is likely to become.
Symptoms may include sneezing, coughing, itching, shortness of breath, abdominal cramps, vomiting, diarrhea, tachycardia, hypotension and respiratory failure in severe cases.
The reaction is usually stopped by the subcutaneous injection of Epinephrine HCL 1:1,000 (See Overdosage below).
The oral administration of antihistamines and the placement of a tourniquet proximal to the injection site are helpful adjuncts.
In the event that additional measures are required, it may be necessary to treat the patient for BRONCHOSPASM with intravenous aminophylline, intravenous fluids and corticosteroids; for HYPOTENSION with vasopressors, volume repletion, isoproterenol and corticosteroids; for LARYNGEAL OBSTRUCTION with oxygen and tracheotomy and for CARDIAC ARREST with cardiopulmonary resuscitation and other appropriate measures.