Standardized Redtop Grass

WARNINGS This product is intended for use by physicians who are experienced in the administration of allergenic extract or for use under the guidance of an allergy specialist. In previously untreated patients, the initial dose must be based on skin testing as described in the dosage and administration section of this insert. Patients being switched from alum-adsorbed or other types of precipitated extracts to this 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 symptoms occur. As with all allergenic extracts, severe systemic reactions may occur and in certain individuals these reactions may be lifethreatening or cause death. Patients should be observed for at least 20 minutes following treatment. 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 to a new lot of extract from the same manufacturer should have the dose reduced 75 percent. For dose selection in switching patients from unstandardized to standardized extract, physicians may refer to Table 3 as a guide (see CLINICAL PHARMACOLOGY). Extracts labeled in BAU/mL are not directly interchangeable with any other grass pollen product. Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine, in the event that epinephrine is required to control an adverse allergic reaction to this product. Caution must be exercised in testing and treating patients with steroid-dependent or labile asthma. This product should never be injected intravenously. See also WARNINGS and ADVERSE REACTIONS below. Serious adverse reactions to this product should be reported to VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

WARNINGS Standardized grass pollen extract must be diluted prior to first use on a patient for immunotherapy or intradermal testing (see DOSAGE AND ADMINISTRATION). Grass pollen extract is manufactured to assure high potency and has the ability to cause serious local and systemic reactions, including death in sensitive patients (14). Patients should be informed of this risk and precautions should be discussed prior to initiating skin testing and immunotherapy (see PRECAUTIONS). Grass pollen extract should be temporarily withheld from a patient if any of the following conditions exist: (a) severe symptoms of rhinitis and/or asthma; (b) infection or flu accompanied by fever; (c) exposure to excessive amounts of grass pollen allergen prior to a scheduled injection. SWITCHING PATIENTS TO STANDARDIZED GRASS POLLEN EXTRACT: The same precautions that are recommended in switching from an old to a new lot of non-standardized grass pollen extract should be followed in switching from non-standardized to standardized grass pollen extract, i.e., the dose of the new lot of standardized grass pollen extract should be reduced 75% of the dose given from an old lot of non-standardized grass pollen extract. Under certain circumstances, it may be advisable to compare the relative potency of the standardized and non-standardized extract by side by side skin testing using comparable v/v dilutions of the concentrates. When switching from alum precipitated grass pollen extract to standardized grass pollen extract, the patient should be managed as a new patient coming under treatment for the first time.

ADVERSE REACTIONS Local reactions consisting of erythema, itching, swelling, tenderness and sometimes pain may occur at the injection site. These reactions may appear within a few minutes to hours and persist for several days. Local cold applications and oral antihistamines may be effective treatment. For marked and prolonged local reactions, steroids may be helpful. Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema and hypotension. Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur. Severe reactions may cause shock and loss of consciousness and fatalities have occurred (14). The treatment of systemic allergic reactions is somewhat dependent upon the symptom complex. Epinephrine hydrochloride 1:1,000 aqueous, in an adult dose of 0.3 - 0.5 mL (or 0.01 mL per kg. for children) administered subcutaneously in the opposite arm is the immediate treatment of choice. A tourniquet should be placed above the site of the injection if the injection was done on the extremities. Antihistamines may offer relief of recurrent urticaria, associated skin reactions and gastrointestinal symptoms. Persistent wheezing may necessitate intravenous aminophylline treatment in addition to inhaled bronchodilators. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen also may be needed. Maintenance of an open airway is critical if upper airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent. Serious adverse reactions to this product should be reported to MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone (800) 332-1088.