Standardized Grass Pollen, Bermuda Grass

STANDARDIZED GRASS POLLEN, BERMUDA GRASS- cynodon dactylon pollen injection, solution
STANDARDIZED GRASS POLLEN, BLUEGRASS, KENTUCKY (JUNE)- poa pratensis pollen injection, solution
STANDARDIZED GRASS POLLEN, FESCUE, MEADOW- festuca pratensis pollen injection, solution
STANDARDIZED GRASS POLLEN, ORCHARD GRASS- dactylis glomerata pollen injection, solution
STANDARDIZED GRASS POLLEN, REDTOP- agrostis gigantea pollen injection, solution
STANDARDIZED GRASS POLLEN, RYEGRASS- lolium perenne pollen injection, solution
STANDARDIZED GRASS POLLEN, SWEET VERNAL GRASS- anthoxanthum odoratum pollen injection, solution
STANDARDIZED GRASS POLLEN, TIMOTHY- phleum pratense pollen injection, solution
STANDARDIZED GRASS POLLEN, GRASS MIX 4- poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen and phleum pratense pollen injection, solution
STANDARDIZED GRASS POLLEN, GRASS MIX 5- poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen, phleum pratense pollen and anthoxanthum odoratum pollen injection, solution
STANDARDIZED GRASS POLLEN, GRASS MIX 7- poa pratensis pollen, dactylis glomerata pollen, agrostis gigantea pollen, phleum pratense pollen, anthoxanthum odoratum pollen, festuca pratensis pollen and lolium perenne pollen injection, solution
Jubilant HollisterStier LLC

WARNINGS

This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction.

Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death 1. Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician’s office if symptoms occur. See ADVERSE REACTION, Section 3, of this insert for information regarding adverse event reporting.

Standardized glycerinated extracts may differ in potency from regular extracts and therefore, are not directly interchangeable with non-standardized extracts, or other manufacturers’ products.

Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. This product should never be injected intravenously. Patients with cardiovascular diseases or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1

CONTRAINDICATIONS
, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections for further discussion.

DESCRIPTION

The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.

Product Concentration:
1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50 EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50 ), Bioequivalent Allergy Units are assigned as follows:

BAU/mL Intradermal Mean Dilution D50
1000,000 1:5,000,000 13-14.9
10,000 1:500,000 11-12.9
1,000 1:50,000 9-10.9

The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture.

2. Concentrate.
a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength.

e.g. Concentrate
50% Short Ragweed 1:20 w/v
25% Kentucky Bluegrass 100,000 BAU/mL
25% Std. Mite D. farinae 10,000 AU/mL

Should the physician choose to calculate the actual strength of each component in the “Concentrate” mixture, the following formulation may be used:

Actual Allergen Strength in Concentrate Mixture = Allergen Manufacturing Strength x Allergen in Formulation (by volume or parts)

b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses , the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate.

CLINICAL PHARMACOLOGY

20

The mechanisms by which hyposensitization is achieved are not completely understood. It has been shown that repeated injections of appropriate allergenic extracts will ameliorate the intensity of allergic symptoms upon contact with the allergen.6, 7, 8, 9 Clinical studies which address the efficacy of immunotherapy are available. The allergens which have been studied are cat, mite, and some pollen extracts.10, 11, 12, 13, 14, 15

IgE antibodies bound to receptors on mast cell membranes are required for the allergic reaction, and their level is probably related to serum IgE concentrations. Immunotherapy has been associated with decreased levels of IgE, and also with increases in allergen specific IgG “blocking” antibody.

The histamine release response of circulating basophils to a specific allergen is reduced in some patients by immunotherapy, but the mechanism of this change is not yet clear.

The relationships among changes in blocking antibody, reaginic antibody, and mediator-releasing cells, and successful immunotherapy need study and clarification.

The CBER has evaluated the potency of eight grass pollen extract reference preparations and assigned potency units (BAU/mL) to each.5 The CBER clinical results follow in Table 1. Puncture data were obtained using a bifurcated needle.

Table 1

PUNCTURE AND INTRADERMAL DATA WITH CBER GRASS REFERENCES 3

Sum of Erythema (mm) Sum of Wheal (mm)
Reference Pollen N Mean Range Mean Range
Bermuda Grass — Cynodon dactylon1590.343-12315.77-31
Kentucky Bluegrass (June) — Poa pratensis1577.347-10715.96-28
Meadow Fescue — Festuca elatior1581.157-11511.97-22
Orchard Grass — Dactylis glomerata1584.357-11114.19-19
Perennial Ryegrass — Lolium perenne1592.373-13517.56-36
Redtop — Agrostis gigantea (alba)1577.142-9814.18-19
Sweet Vernalgrass — Anthoxanthum odoratum1581.228-12315.78-30
Timothy — Phleum pratense1588.351-10916.98-40

B. Intradermal Dose of CBER Grass References for 50mm Sum of Erythema (BAU50 )

Reference Pollen Mean BAU50 /mL Range
Bermuda Grass — Cynodon dactylon0.020.4-0.0003
Kentucky Bluegrass (June) — Poa pratensis0.020.1-0.004
Meadow Fescue — Festuca elatior0.020.9-0.002
Orchard Grass — Dactylis glomerata0.021.9-0.002
Perennial Ryegrass — Lolium Perenne0.020.7-0.002
Redtop — Agrostis gigantea (alba)0.020.8-0.004
Sweet Vernalgrass — Anthoxanthum odoratum0.021.0-0.002
Timothy — Phleum pratense0.020.6-0.002
TABLE 2

RELATIVE POTENCY OF PREVIOUSLY MANUFACTURED AND DISTRIBUTED NON-STANDARDIZED GRASSES TO CBER REFERENCE STANDARDS

# of Jubilant HollisterStier LLC Lots Relative to the CBER Reference*
Pollen# of Lots TestedLess thanEqual toGreater ThanCalculated BAU/mL Range** (Rounded to the nearest 000)
Orchard Grass20213566,000 — 242,000
Perennial Ryegrass17512025,000 — 127,000
Sweet Vernalgrass13112073,000 — 110,000
Kentucky Bluegrass21812132,000 — 145,000
Redtop2056913,000 — 402,000
Meadow Fescue 210120128,000 — 948,000
Bermuda Grass2231366,000 — 28,000
Timothy19116243,000 — 176,000

**BAU/mL ranges between 69,990 and 143,100 are considered equivalent to the CBER 100,000 BAU/mL Standard, and between 6,990 and 14,310 for the CBER 10,000 BAU/mL Standard when assays are done in triplicate.

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