Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE 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)

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Advisory information

contraindications
CONTRAINDICATIONS 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.
Special warnings and precautions
PRECAUTIONS GENERAL 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. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long term studies with extracts have not been conducted in animals to determine their potential for carcinogenesis, mutagenesis, or impairment of fertility. PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed. Controlled studies of hyposensitization with moderate to high doses of allergenic extracts in pregnant women have failed to demonstrate any risk to the mother or fetus. (6) However, with histamines known ability to contract uterine muscles any reaction which would release significant amounts of histamine such as hyposensitization overdose should be avoided. The physician must weigh the benefits of immunotherapy against the risk of anaphylactic reactions that could result in harm to the mother and/or fetus. Hyposensitization should be used during pregnancy only if clearly necessary and administered cautiously. If a woman is on maintenance dose the occurrence of pregnancy is not an indication to stop injection therapy. NURSING MOTHERS: It is not known if allergenic extracts are excreted in human milk therefore caution should be exercised when extracts are administered in nursing women. PEDIATRIC USE: Doses of allergenic extracts for children are generally the same as those for adults. The extracts may cause some pain or discomfort when injected. The maximum tolerated dose may be less than the adult dose due to the smaller size of the child. Therefore, the volume of the dose may need to be adjusted from the adult schedules provided. DRUG INTERACTIONS: 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.
Adverse reactions
ADVERSE REACTIONS 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)

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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. BAU/ml to elicit 50mm sum of Diameter of Erythema reaction Number of Patients Mean Range 10 0.0128 0.0021-0.1957 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. SCRATCH OR PUNCTURE TEST: Concentration Dosage 10,000 BAU/ml 0.05 ml (1 drop) INTRADERMAL TEST: A. Patients with a negative scratch or puncture test. Concentration Dosage 1) 50 BAU/ml 0.02 ml 2) 100 BAU/mlThe negative intradermal control used for the 100 BAU/ml concentration should contain 0.5% (v/v) glycerin. if 50 BAU/ml is negative B. Patients tested by intradermal only. Concentration Dosage 0.5 BAU/ml 0.02 ml If negative, repeat tests with stronger concentrations until a maximum of 100 BAU/ml is reached.
Pregnancy and lactation
NURSING MOTHERS: It is not known if allergenic extracts are excreted in human milk therefore caution should be exercised when extracts are administered in nursing women.

Interactions

DRUG INTERACTIONS: 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.

More information

Category Value
Authorisation number BLA103324
Agency product number 1564HD0N96
Orphan designation No
Product NDC 54575-288
Date Last Revised 06-03-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 851948
List of excipients INACTIVE INGREDIENTS Glycerinated extracts contain: glycerin 50.0 % v/v sodium chloride 0.166 % w/v sodium bicarbonate 0.091 % w/v
Storage and handling STORAGE These extracts should be stored at 2 to 8 degrees Celsius. Excessive heating (above room temperature) and repeated freeze-thawing should be avoided. The dating period (expiration date) is shown on the vial label. Once extracts are diluted the shelf life decreases. Extracts should be re-ordered when out of date. Please allow a minimum of three (3) weeks for delivery due to the holding period for sterility testing.
Marketing authorisation holder Allergy Laboratories, Inc.
Warnings WARNING This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Extracts standardized using Bioequivalent Allergy Unit (BAU/ml) may be more potent than nonstandardized cat extracts based on the weight to volume, or PNU methods. Allergy Laboratories' standardized cat hair extract is not interchangeable with standardized cat pelt extracts, and also not interchangeable with other standardized cat extracts labeled in Allergy Units (AU/ml). The initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from nonstandardized cat extracts to Allergy Laboratories' standardized cat extract should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physicians office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life threatening reactions may be fatal. Patients should be observed for at least 30 minutes following treatment and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. This product should not be injected intravenously. Subcutaneous injections are recommended. 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. Refer also to the warnings, precautions, adverse reactions and dosage sections below.