FDA label 6199232a-c457-4b50-9112-794d25418367

WARNING This product should be used only by or under the direction of physicians experienced in administering allergens to the maximum tolerated dose and the emerg ency treatment of anaphylaxis, and only where adequate means for treating severe systemic reactions are immediately available . This standardized cat hair extract is not interchangeable with non-standardized extracts, cat pelt extracts or with extracts labeled in allergy units per mL (AU/mL). See Description , Warnings , and Dosage and Administration sections for further information. Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death 1 . Because of the possibility of severe systemic reactions, the patient should be instructed in the recognition of anaphylactic symptoms, observed in the office for 20 to 30 minutes after each injection, and warned to return to the office if symptoms of an allergic reaction occur. Serious adverse events should be reported to the FDA MedWatch Program: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787, (1 -800-FDA-1088) Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators, and the risk of severely complicating the treatment of systemic reactions should be carefully considered before a decision to treat is reached. Care should also be taken with patients with unstable or steroid-dependent asthma, or with underlying cardiovascular disease. Before administering this or any allergenic extract, physicians should be thoroughly familiar with the information in this insert, especially the Warnings, Precautions, and Adverse Reactions sections.

WARNINGS See additional warnings given in the box at the beginning of this insert. Do not use this extract or allow its use until you have read this insert, and have taken adequate precautions to prevent inadvertent dosage errors. See Dosage and Administration for further information. Some patients are highly sensitive to allergenic extracts, and in such patients even a small skin test dose could result in a serious systemic reaction. Adequate means to treat such reactions must be immediately available, including the following equipment 8 : stethoscope and sphygmomanometer; tourniquets, syringes, hypodermic needles, and large-bore (14 gauge) needles; aqueous epinephrine HCI 1:1000;oxygen, intravenous fluids and the equipment for administering them; oral airway; diphenhydramine or similar antihistamine; aminophylline and corticosteroids for intravenous injection; and vasopressor. Observing the following precautions will reduce the risk of serious systemic reactions: Do not begin immunotherapy without establishing the appropriate initial dose by skin testing (see Dosage and Administration ), and do not inject the undiluted extract concentrate at any time unless tolerance has been demonstrated. When changing to an extract from a different manufacturer establish the proper dosage by skin testing. When changing to a different lot of extract, reduce the dose by 50-75%; this is particularly important after using an extract that is near its expiration date. Take care to properly prepare, label store and control all dilutions. Use caution in dosing of high-risk steroid-dependent labile asthmatics. DO NOT GIVE INTRAVENOUSLY. After inserting the needle subcutaneously, but before injecting the dose, retract the plunger of the syringe slightly. If blood appears in the syringe, discard the syringe and its contents and repeat the injection at another site. Subcutaneous injection is recommended because intracutaneous or intramuscular injections are more likely to produce local reactions. Observe the patient at 20 to 30 minutes after injection, and be alert for the signs of impending reaction. Make sure the patient understands that serious delayed reactions can occur later on, how to recognize them, and what to do if they occur. Patients who are receiving beta-blocking medication are high-risk patients for immunotherapy, because systemic reactions to the extract may be more severe in such patients 9 , and because the beta-blocker may impair the ability to reverse the reaction 10 in such patients. This risk should be carefully weighed before a decision to treat is reached. Care should also be taken with patients with unstable or steroid-dependent asthma or with underlying cardiovascular disease. This and any allergenic extract should be temporarily withheld or its dosage reduced under any of these conditions 11 : When the patient has an unexpectedly severe local or any systemic reaction to the previous dose. If the patient is experiencing allergic symptoms such as rhinitis or asthma or is ill with flu or infection accompanied by fever. If an unusually long time has passed since the previous injection. If the patient is exposed to excessive amounts of clinically relevant allergen prior to therapy. Allergic patients differ widely in their sensitivity to this or any allergenic extract, and no single dosage regimen can be recommended for all patients. Progression to the next higher dose requires tolerance of the previous one, and the regimen must be modified if any of the conditions described above occur. Such modifications should include weaker dilutions and smaller dosage increments.

ADVERSE REACTIONS Severe anaphvlactic reactions to this extract can occur in extremely allergic patients and at any dosage level. Do not use this extract unless you are prepared to deal with these reactions, and until you have read and understood the warnings, precautions, and dosage and administration sections of this insert. The most serious systemic reaction that can occur is anaphylactic shock which while rare, is life threatening and must be treated immediately. Among other systemic reactions that have occurred are laryngeal edema, fainting, pallor bradycardia, hypotension, bronchospasm, angioedema, cough, sneezing, conjunctivitis, rhinitis, and urticaria. Should a serious systemic reaction occur: Inject 0.3-0.5 ml of 1:1000 epinephrine into the opposite arm; this may be repeated every 5 to 10 minutes, as a succession of smaller doses is more effective and less dangerous than a single larger one. Use a smaller dose for infants and children, in the range of 0.01 ml/kg of body weight. Apply a tourniquet proximal to the injection site; loosen it at least every 10 minutes interval. Inject no more than 0.1 ml of 1:1000 epinephrine at the injection site, to delay the absorption of the remaining extract. Beta adrenergic agonists or aminophylline may be helpful in alleviating bronchospasm and airway obstruction. Other treatments that may be of benefit include H 1 antihistamines (e.g., 1 mg/kg diphenhydramine) and glococorticoids (e.g., 120 mg methylprednisolone). These measures will almost always reverse the reaction but in the rare instances when they do not, then the full armamentarium of emergency medicine may be required, among them: direct laryngoscopy direct current cardioversion, tracheotomy, and intracardiac injection of drugs 8 . The occurrence of a severe systemic reaction to an injection of this extract does not contraindicate further therapy, but the next dose given should be reduced by at least 90% and raised very slowly thereafter. If a pattern of systemic reactions- even very mild ones- appears, then the benefits of continued treatment must be carefully weighed against the substantial demonstrated risk. Local reactions, even relatively severe but transient redness, swelling and discomfort, are the normal physiologic response to the allergens and to the volume of the fluid injected, and in their milder forms are not unexpected. Local reactions generally subside quickly and do not require treatment, but application of cold to the injection site or other symptomatic measures may be useful. However, severe local reactions should be considered a warning of potential systemic reaction if that dosage is continued. Always reduce the dose substantially if such a local reaction occurs. Overdosage: See Adverse Reactions section.