FDA label 745162a9-2fdc-4b03-a3bc-32d410b3d9c1

WARNINGS Standardized allergenic extract is intended for use by physicians who are experi­enced in the administration of standardized (AU/ml) allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized allergenic extracts are not directly interchange­able with other allergenic extracts. 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 extract to standardized allergenic extracts 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. In certain individuals, these life-threatening 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. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe, see "WARNINGS", "PRECAUTIONS", "ADVERSE REACTIONS" and "OVERDOSAGE" sections. Sensitive patients may experience severe anaphylactic reactions resulting in res­piratory obstruction, shock, coma and/or death. 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 "WARNINGS", "PRECAUTIONS", and "ADVERSE REACTIONS" sections.

WARNINGS Extreme caution is necessary when using diagnostic skin tests or injection treatment in highly sensitive patients, who have experienced severe symptoms or anaphylaxis by natural exposure or previous skin testing or treatment. IN THESE CASES BOTH THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT'S SENSITIVITY TOLERANCE. Refer to boxed “WARNINGS" and "OVERDOSAGE" section. Epinephrine 1:1000 should be available. When changing immunotherapy from an unstandard­ized to an AU/ml standardized allergenic extract , dose adjustment, if indicated, should be based on such considerations as the results of skin endpoint titration (see "INDICATIONS AND USAGE" section). Patient re-evaluation may be necessary. Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe will allow deep subcutaneous injection. Precaution of withdrawing the plunger slightly after inserting the needle is advisable to determine if a blood vessel has been entered. DO NOT INJECT INTRAVENOUSLY. Proper measurement of the dose and caution in making the injection will minimize reactions. Patients should be detained for twenty to thirty minutes after injection and advised to notify the office immediately if symptoms or reac­tions occur. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced to 75%. Also, this extract should be temporarily withheld or dosage reduced in the following conditions: 1) flu or other infection with fever; 2) exposure to excessive amounts of allergen prior to injection; 3) rhinitis and/or asthma exhibiting severe symptoms.

ADVERSE REACTIONS Adverse reactions include, but are not necessarily limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing. 1) Local Reactions Small amounts of erythema and swelling at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter. Larger local reactions are not only uncomfortable, but indicate the possibility of a sys­temic reaction if dosage is increased. In such cases, the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again. Large, persistent local reactions or minor exacerbations of the patient's allergic symp­toms may be treated by local cold applications and/or use of oral antihistamines, but they should be considered a warning of possible severe systemic reactions and the need for temporarily reduced dosages. A mild burning immediately after the injection is to be expected; this usually leaves in 10-20 seconds. Prolonged pain is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route. 2) Systemic Reactions Systemic reactions range from mild exaggeration of patient's allergic symptoms to ana­phylactic reactions. Very sensitive patients may show a rapid response. In some instances, a severe systemic reaction with blood pressure fall and/or shock may occur. Quantitation of patient's sensitivity combined with careful early observation is essential for safe skin testing and treatment. Reports from regulatory authorities in Sweden to the F.D.A. indicated that several deaths have been associated with the use of mite extracts. The F.D.A. was subsequently informed that these deaths may have been related to use by physicians untrained in the administration of potent extracts rather than a product defect. 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 in the British Medical Journal, Vol. 293, p. 948, 1986. 24 Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. The following are commonly prescribed beta-blockers : Levatol, Lopressor, Propanolol Intersol, Propanolol HCL, Blocadren, Propanolol, Inderal-LA, Visken, Corgard, Ipran, Tenormin, Timoptic. Ophthalmic beta-blockers: Betaxolol, Levobunolol, Timolol, Timoptic. Chemicals that are beta-blockers and may be components of other drugs: Acebutolol, Atenolol, Esmolol, Metoprolol, Nadolol, Penbutolol, Pindolol, Propanolol, Timolol, Labetalol, Carteolol.