Standardized Bermuda Grass

STANDARDIZED BERMUDA GRASS- cynodon dactylon pollen injection
STANDARDIZED MEADOW FESCUE GRASS- festuca pratensis pollen injection
STANDARDIZED ORCHARD GRASS- dactylis glomerata pollen injection
STANDARDIZED PERENNIAL RYE GRASS- lolium perenne pollen injection
STANDARDIZED KENTUCKY BLUE (JUNE) GRASS- poa pratensis pollen injection
STANDARDIZED REDTOP GRASS- agrostis gigantea pollen injection
STANDARDIZED SWEET VERNAL GRASS- anthoxanthum odoratum pollen injection
STANDARDIZED TIMOTHY GRASS- phleum pratense pollen injection
Allermed Laboratories, Inc.

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 MEDWATCH, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088.


DESCRIPTION

Standardized grass pollen extract is a sterile solution containing the extractables of grass pollen in 0.25% sodium chloride, 0.125% sodium bicarbonate, 50% glycerol v/v and 0.4% phenol w/v. Standardized grass pollen extracts include Bermuda Grass ( Cynodon dactylon), June Grass ( Poa pratensis), Meadow Fescue Grass ( Festuca elatior), Orchard Grass ( Dactylis glomerata), Perennial Rye Grass ( Lolium perenne), Redtop Grass ( Agrostis alba), Sweet Vernal Grass ( Anthoxanthum odoratum) and Timothy Grass ( Phleum pratense).

The extract may be administered by the scratch, prick, puncture, or intradermal methods of skin testing for diagnostic purposes and subcutaneously for therapeutic purposes as directed under Dosage and Administration.

The potency of standardized grass pollen extracts is expressed in Bioequivalent Allergy Units per mL (BAU/mL) and is determined by an in vitro ELISA Competition Assay comparing the extract to a U.S. reference grass pollen extract available from the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration. Bioequivalent Allergy Units per mL (BAU/mL) have been assigned to the reference extract based on quantitative skin testing (see CLINICAL PHARMACOLOGY). CBER reference extract labeled 100,000 BAU/mL can be diluted 1:5 million and yield a 50 mm sum of erythema diameter response intradermally in highly puncture reactive subjects. CBER reference extract labeled 10,000 BAU/mL can be diluted 1:500,000 for the same response. 12

Allermed’s standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alumprecipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.

CLINICAL PHARMACOLOGY

It is estimated that grass pollen is responsible for 10 — 30% of all IgE-mediated allergies worldwide 1. Temperate grasses, including Dactylis glomerata (Orchard Grass), Lolium perenne (Rye Grass), Phleum pratense (Timothy Grass) and Poa pratensis (Blue Grass), have practically identical allergenic characteristics. Subtropical grasses, such as Cynodon dactylon (Bermuda Grass), are antigenically distinct from temperate grasses and should be regarded as separate allergenic sources. For effective testing and treatment with grass pollen extracts, the extracts must be properly selected to represent the allergenic enviornment of the allergic individual 1,2,3,4.

Grass pollen extract may have as many as 40 components, of which 5 — 10 may be allergenic. The most important allergens are classified into groups I — VI. Allergens in these groups account for 90 — 100% of the IgE binding prevalence in the serum of grass pollen allergenic patients 1,5.

The pharmacologic action of grass pollen extract used diagnostically is based on the liberation of histamine and other substances when allergens in the extract react with specific IgE antibody attached to mast cells. The release of pharmacologically active mediators from mast cell results in the wheal-flare reaction associated with a positive skin test 6,7.

The basis for the clinical improvement of allergic symptoms following immunotherapy with grass pollen extract is not clearly understood. Several immunologic changes have been demonstrated that might be responsible for the amelioration of allergenic symptoms. These changes include (a) increase in serum IgG antbodies, (b) blunting of the seasonal rise of IgE antibodies, (c) elevation of blocking IgA/IgG antibodies in secretions, (d) reduced basophil reactivity and sensitivity to allergens and (e) reduced in vitro lymphocyte responsiveness to allergens 8. There is evidence that symptoms are effectively altered only by the administration of the relevant allergen 9,10,11.

The results shown in Table 1 were observed with 10,000 BAU/mL reference extract administered to 15 highly sensitive grass allergic persons by the puncture method (data on file at FDA). The intradermal doses (BAU/mL) of grass pollen extracts required to elicit 50 mm sum of erythema are shown in Table 2 12.

Table 1. Puncture data (bifurcated needle) with 10,000 BAU/mL reference grass pollen extracts.
*
P∑E = Sum of erythema of the longest and orthogonal diameters.
P∑W = Sum of edema (wheal) of the longest and orthogonal diameters.
P∑E (mm) * P∑W (mm)
Reference Pollen FDA lot N Mean Range Mean Range
Bermuda E4-Ber 15 90.3 43-123 15.7 7-31
June E3-Jkb 15 77.3 47-107 15.9 6-28
Meadow Fescue E4-MF 15 81.1 57-115 11.9 7-22
Orchard E4-OR 15 84.3 57-111 14.1 9-19
Perennial Rye E10-Rye 15 92.3 73-135 17.5 6-36
Redtop E4-RE 15 77.1 42-98 14.1 8-19
Sweet Vernal E4-SV 15 81.2 28-123 15.7 8-30
Timothy E6-Ti 15 88.3 51-109 16.9 8-40

Note: Relative potency compared to the U.S. Reference with potency of 1.0. The U.S. Reference for Bermuda Grass is 10,000 BAU/mL (range:6,900 — 143,000 BAU/mL). The U.S Reference for other grasses are 100,000 BAU/mL (range: 69,000 — 143,000 BAU/mL).

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. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook 13.

Allermed’s standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alumprecipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.

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