Phleum pratense pollen

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. 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. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts.

Parental drug products should be inspected visually for particulate matter and discoloration prior to adminitration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed. DIAGNOSTIC USE: Standardized grass pollen extract may be used to diagnose sensitivity to grass pollen by performing skin tests on persons with a history of grass pollen allergy. Due to the risk of adverse reactions occuting in highly sensitive persons, it is mandatory to initially test all patients percutaneously using the scratch, prick or puncture method. If a properly performed percutaneous test is negative, an intradermal test may be used with caution. PUNCTURE TEST: The punture test should be performed first with 10,000 BAU/mL extract. Data for the puncture test using 10,000 BAU/mL extract are summarized in Table 1 under CLINICAL PHARMOCOLOGY.

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. Other contraindications include: EXTREME SENSITIVITY TO GRASS POLLEN: Patients who experience serious adverse reactions to grass pollen extract from skin testing and/or immunotherapy should not be given the product. AUTOIMMUNE DISEASE: Individuals with autoimmune disease may be at risk, due to the possibility of routine immunizations exacerbating symptoms of the underlying disease.

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. Standardized grass pollen extract must be diluted prior to first use on a patient for immunotherapy or intradermal testing. 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. Patients should be informed of this risk and precautions should be discussed prior to initiating skin testing and immunotherapy.

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. The treatment of systemic allergic reactions is somewhat dependent upon the symptom complex.

The extract should be stored at 2 - 8°C, if possible, and kept in this temperature range during office use.