FDA label 272c9910-2160-4d41-afbd-faab3055ba1d

WARNINGS Allergenic extract is intended for use by, or under the guidance of, physicians who are experienced in the administration of allergenic extracts for diagnosis and/or immunotherapy and the emergency care of anaphylaxis. This extract is 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 switching from other types of extracts to Antigen Laboratories’ allergenic extracts should be started as if they were undergoing treatment for the first time. Patients being switched from one lot of extract to another from the same manufacturer should have the dose reduced by 75%. Severe systemic reactions may occur with all allergenic extracts. In certain individuals, especially in steroid-dependent/unstable asthmatics, these life-threatening reactions may result in death. Patients should be observed for at least 20 minutes following allergenic extract injections. Treatment and emergency measures, as well as personnel trained in their use, must be available in the event of a life-threatening reaction. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Report serious adverse events to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, phone 1-800-FDA-1088. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. See the “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections. 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 below.

WARNINGS Refer to boxed “WARNINGS”, “PRECAUTIONS”, “ADVERSE REACTIONS” and “OVERDOSAGE” sections for additional information on serious adverse reactions and steps to be taken, if any occur. 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 during previous skin testing or treatment. IN THESE CASES THE POTENCY FOR SKIN TESTS AND THE ESCALATION OF THE TREATMENT DOSE MUST BE ADJUSTED TO THE PATIENT’S SENSITIVITY AND TOLERANCE. Benefit versus risk needs to be evaluated in steroid dependent asthmatics, patients with unstable asthma or patients with underlying cardiovascular disease. Injections should never be given intravenously. A 5/8 inch, 25 gauge needle on a sterile syringe allows deep subcutaneous injection. Withdraw plunger slightly after inserting needle to determine if a blood vessel has been entered. Proper measurement of dose and caution in making injection will minimize reactions. Adverse reactions to allergenic extracts are usually apparent within 20-30 minutes following injection of immunotherapy. Extract should be temporarily withheld or dosage reduced in case of any of 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; 4) adverse reaction to previous injection until cause of reaction has been evaluated by physician supervising patient’s immunotherapy program.

ADVERSE REACTIONS Adverse reactions include, but are not 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 A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route. Small amounts of erythema and swelling at the site of injection are common. 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 severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing. 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. 2) Systemic Reactions Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions. 14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur. 5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria. 13, 14 Careful attention to dosage and administration limit such reactions. 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 prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.