Standardized Cat Hair

WARNINGS This allergenic 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. Standardized Cat Hair Extract is not directly interchangeable with Standardized Cat Pelt Extract or 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 other types of cat extracts to Standardized Cat Hair 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 reactions may result in death. Patients should be observed for at least 20 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 (see Dosage and Administration). Refer also to the warnings, precautions, adverse reactions and overdosage sections below. Serious adverse reactions to this product should be reported to MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, MD 20852-9787. Telephone 1-800-822-7967 or www.vaers.hhs.gov.

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.

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.