STANDARDIZED BERMUDA GRASS POLLEN

STANDARDIZED BERMUDA GRASS POLLEN- cynodon dactylon pollen injection, solution
STANDARDIZED KENTUCKY BLUEGRASS POLLEN- poa pratensis pollen injection, solution
STANDARDIZED MEADOW FESCUE GRASS POLLEN- festuca pratensis pollen injection, solution
STANDARDIZED ORCHARD GRASS POLLEN- dactylis glomerata pollen injection, solution
STANDARDIZED REDTOP GRASS POLLEN- agrostis gigantea pollen injection, solution
STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN- lolium perenne pollen injection, solution
STANDARDIZED SWEET VERNAL GRASS POLLEN- anthoxanthum odoratum pollen injection, solution
STANDARDIZED TIMOTHY GRASS POLLEN- phleum pratense pollen injection, solution
Allergy Laboratories, Inc.

ALLERGY LABORATORIES, INC.
Oklahoma City OK 73109

INSTRUCTIONS AND DOSAGE SCHEDULE FOR STANDARDIZED ALLERGENIC EXTRACTS

BERMUDA GRASS POLLEN (Cynodon dactylon)

KENTUCKY BLUE GRASS POLLEN (Poa pratensis)

MEADOW FESCUE POLLEN (Festuca elatior)

ORCHARD GRASS POLLEN (Dactylis glomerata)

REDTOP GRASS POLLEN (Agrostis alba)

PERENNIAL RYE GRASS POLLEN (Lolium perenne)

SWEET VERNAL GRASS POLLEN (Anthoxanthum odoratum)

TIMOTHY GRASS POLLEN (Phleum pratense)

WARNING

This product is intended for use by physicians who are experienced in the administration of allergenic extracts and the emergency care of anaphylaxis or for use under the guidance of an allergy specialist.

STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ml ARE NOT INTERCHANGEABLE WITH G RASS POLLEN EXTRACTS LABELED IN AU/ml OR WITH NON-STANDARDIZED (WEIGHT/VOLUME) GRASS POLLEN EXTR A CT S. For guidance in selecting dose, refer to Table A in the Clinical Pharmacology section that describes the potency of non-standardized grass pollen extracts. Comparative skin tests can be performed to determine the relative potency before initial use of new extracts. For previously untreated patents, initial dose must be based on skin testing as described in the Dosage and Administration section of this insert. Patients being switched from other types of extracts to Allergy Laboratories should have their dose adjusted. Extracts standardized in BAU (Bioequivalent Allergy Unit) may differ in potency from non-standardized extracts. Comparative skin tests can be performed to determine relative potency of standardized versus non-standardized extracts. The dosage should be reduced 75% when switching from one lot of standardized grass pollen extract to another Iot. Patients with unstable or severe asthma, including steroid-dependent asthma, are at increased risk for more frequent and more severe reactions from allergy extract injections. Greater caution must be exerted with such patients at all phases of extract administration, but particularly during build up. For example, extract therapy might be initiated at weaker concentrations and built by smaller dosage increments than in comparably allergic rhinitis patients without asthma. Also when asthma is poorly controlled, the injection regimen might be temporarily interrupted (at the discretion of the physician) until control of asthma is re-established. Whenever a reaction occurs in such patients their asthma should be medically stabilized before injections are resumed with an appropriate dosage reduction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact physician’s office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. In certain individuals these life threatening reactions may be fatal. Patients should be observed for at least 30 minutes following treatment and emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. Serious adverse reactions can be reported to the U S Food and Drug Administration MedWatch Program. The MedWatch forms can be obtained by calling 1-800-FDA-1088. The address is MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

This product should not be injected intravenously. Subcutaneous injections are recommended.

Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Refer also to the warnings, precautions, adverse reactions and dosage sections below.

DESCRIPTION:

Standardized grass pollen extracts labeled in BAU/ml are not interchangeable with grass pollen extracts labeled in AU/ml or with non-standardized grass pollen extracts. The recommended route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Do not inject intravenously. The extract is sterile and contains 50% (v/v) glycerin as a preservative. Standardized grass pollen extracts are available in both 10,000 BAU/ml and 100,000 BAU/ml potencies, except for Bermuda which is only available in 10,000 BAU/ml. The source material of the standardized grass extracts are the grass pollens. The 100,000 BAU/ml grass pollen extracts are prepared by extracting pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 100,000 BAU/ml. The 10,000 BAU/ml grass pollen extracts are prepared by dilution of the 100,000 BAU/ml grass pollen extracts. The 10,000 BAU/ml Bermuda grass pollen extract is prepared by extracting Bermuda grass pollen at a 1:10 w/v ratio then diluting if necessary to the appropriate range for 10,000 BAU/ml.

The potency (in Bioequivalent Allergy Units per ml or BAU/ml) of standardized grass pollen extracts is determined by an in-vitro ELISA Competition assay (1) against CBER reference extracts and CBER reference serum pools distributed by the Center for Biologics Evaluation and Research, U S Food and Drug Administration. Potency based on Bioequivalent Allergy Units (BAU/ml) is printed on the label. FDA reference grass pollen extracts were assigned potency designations based on quantitative skin testing (2). The FDA reference extracts which can be diluted 1:500,000 fold intradermally to produce a sum of erythema diameter response of 50mm in highly puncture reactive subjects have been assigned 10,000 BAU/ml. References which can be diluted 1:5,000,000 fold intraderrnally to produce a sum of erythema diameter response of 50mm have been assigned 100,000 BAU/ml.

INACTIVE INGREDIENTS:

Glycerinated extracts contain:

glycerin 50.0 % v/v
sodium chloride 0.166 % w/v
sodium bicarbonate 0.091 % w/v

CLINICAL PHARMACOLOGY:

The allergic state is initiated by an immune response inducing B cells to produce IgE antibodies to specific allergens. IgE antibodies bind to surface receptors on mast cells and basophils. When antigens gain access to the immune system they react with the bound IgE. The reacting antigen to the surface bound IgE stimulates a number of chemical mediators to be released from the mast cells and basophils. These include histamine, Eosinophil Chemotactic Factor (ECF-A) and leukotrienes. These chemical mediators are pharmacologically active at low concentrations and are partially responsible for the biological manifestations of the allergic response. (3)

The mechanism by which immunotherapy achieves hyposensitization is not completely understood. There is an increase in “blocking antibody” (lgG) titer and in some patients a decrease in specific IgE, a decrease in histamine release to specific allergen and an increase in suppressor celI population to specific allergen. These changes may occur only after prolonged therapy. (4)

TABLE A Potency of Commercially Available Allergy Laboratories, Inc. Non-standardized Grass Pollen Extracts (glycerinated 1:20 w/v) In-vitro data by ELISA Competition Assay
Potency in BAU/ml BAU/ml Range for Equivalence to Reference
GRASS POLLEN EXTRACT Lot #1 Lot #2
Bermuda 14,600 8,500 6,999- 14,310
Kentucky Blue 94,000 150,000 69,990-143,100
Meadow Fescue 275,000 105,000 69,990-143,100
Orchard 96,000 Not tested 69,990-143,100
Redtop 117,000 58,000 69,990-143,100
Perennial Rye 195,000 101,000 69,990-143,100
Sweel Vernal 67,000 72,000 69,990-143,100
Timothy 140,000 149,000 69,990-143,100

Clinical data from the Center for Biologics Evaluation and Research is shown in the following tables

TABLE B Puncture and Intradermal Data with CBER Grass Pollen References
1. Puncture Data with 10,000 BAU/ml Grass Pollen Extracts using bifurcated needle
Reference Pollen FDALot # N P∑E (mm) Mean Range P∑W (mm)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-Rt 15 77.1 42-98 14.1 8-19
Sweel Vernal E4-SV 15 81.2 28-123 15.7 8-30
Timothy E6-T 15 88.3 51-109 16.9 8-40
∑E = The sum of the longest diameter of erythema and the orthogonal erythema diameter measured at one half the longest erythema diameter.
∑W = The sum of the longest diameter of wheal and the orthogonal wheal diameter measured at one half the longest wheal diameter.
2. Intradermal Dose of CBER Grass Pollen References for 50mm Sum of Erythema (BAU50 )
Reference Pollen FDALot # BAU50 /ml Mean Range
Bermuda E4-Ber 0.02 0.4 – 0.0003
June E3-Jkb 0.02 0.1 – 0.004
Meadow Fescue E4-MF 0.02 0.9 – 0.002
Orchard E4 Or 0.02 1.9 – 0.002
Perennial Rye E10-Rye 0.02 0.7 – 0.002
Redtop E4-Rt 0.02 0.8 – 0.004
Sweel Vernal E4-SV 0.02 1.0 – 0.002
Timothy E6-Ti 0.02 0.6 – 0.002
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