Festuca Elatior

INDICATIONS AND USAGE Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing.

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).

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. 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. CONTRAINDICATIONS Immunotherapy should not be started in patients until a specific diagnosis of Type I allergy to grass pollen has been made from the patient's allergy history and from a positive skin test to grass pollen extract.