FDA label 55746080-edfc-4d38-9d49-85a4329bbd2c

WARNINGS Standardized allergenic extract is intended for use by physicians who are experienced in the administration of allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized Cat Pelt extract is not interchangeable with standardized Cat Hair extract or with any non-standardized Cat extracts. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same-labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract. 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 extracts standardized or unstandardized cat extracts from other suppliers, to this standardized allergenic 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 physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. In certain individuals, these life-threatening reactions may rarely result in death. Patients should be observed for 20 to 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. Deep subcutaneous routes have proven to be safe. See the warnings , precautions , adverse reactions and overdosage sections below. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Adverse events are to be reported to MedWatch (1-800-FDA-1088), Adverse Experience Reporting, HFM-210 Center for Biologics Evaluation & Research, Food & Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously. Refer to the warnings, precautions and adverse reaction sections below.

WARNINGS See warnings at beginning of this package insert. Standardized allergenic extracts may be more potent than non-standardized extracts. This cat extract may be compositionally different than unstandardized and standardized extracts from other suppliers. This cat extract is prepared from cat pelt and should not be interchanged with Standardized Cat Hair Extract or Standardized Cat Pelt Extract from other sources. This product has been assigned a bioequivalent allergy unit (BAU) designation based on both in vivo and in vitro potency measures. The physician should perform skin tests to determine the initial starting dose for standardized extracts. From standardized aqueous extracts from other manufacturers to ALK-Abello standardized aqueous extracts: The physician should establish the potency relationship, perhaps by comparative skin testing at equal concentration, prior to injecting the first standardized dose. Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1,000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL . The tourniquet is then gradually released at 15 minute intervals. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine. Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation. PRODUCT SHOULD NOT BE GIVEN INTRAVENOUSLY. In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with the allergenic extract injections. Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions: - Severe rhinitis or asthma symptoms; - Infection or flu accompanied by fever; - Exposure to excessive amounts of clinically relevant allergen prior to therapy.

ADVERSE REACTIONS Local: Reactions at the site of injection may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence, but if very large, may be the first manifestation of systemic reaction. If large local reactions occur, the patient should be observed for systemic symptoms for which treatment is outlined below. However, systemic reactions may occur in the absence of large local reactions. Delayed reactions start several hours after injection with local edema, erythema, itching or pain. They are usually at their peak at 24 hours and usually require no treatment. Antihistamine drugs may be administered orally. The next therapeutic dose should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions. Systemic: It should be noted that anaphylaxis and deaths following the injection of mite and other extracts have also been reported by The British Committee on Safety in Medicine 10 . Fatalities from immunotherapy in the United States since 1945 have been extensively reviewed by Lockey, R F, et al. 11 and by Reid, M J et al. 12 . With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Systemic reactions are characterized by one or more of the following symptoms: Sneezing, mild to severe general urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, hypotension, syncope and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for 20 to 30 minutes after any injection. Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction, unresponsive to bronchodilator may require tracheal intubation and use of oxygen. In the event of a marked systemic reaction, application of a tourniquet above the injection site and the administration 0.02 mL to 1.0 mL of Epinephrine Injection (1:1,000) is recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes. The next therapeutic injection of extract should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.