Standardized Bermuda Grass
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Questions & Answers
Side Effects & Adverse Reactions
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 patients14. 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.
SWITCHING PATIENTS TO STANDARDIZED GRASS POLLEN EXTRACT: The same precautions that are recommended in switching from an old to a new lot of non-standardized grass pollen extract should be followed in switching from non-standardized to standardized grass pollen extract, i.e., the dose of the new lot of standardized grass pollen extract should be reduced 75% of the dose given from an old lot of non-standardized grass pollen extract. Under certain circumstances, it may be advisable to compare the relative potency of the standardized and non-standardized extract by side by side skin testing using comparable v/v dilutions of the concentrates.
When switching from alum precipitated grass pollen extract to standardized grass pollen extract, the patient should be managed as a new patient coming under treatment for the first time.
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FDA Labeling Changes
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Uses
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 textbook13.
Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.
History
There is currently no drug history available for this drug.
Other Information
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 response12.
Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.
Sources
Standardized Bermuda Grass Manufacturers
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Allermed Laboratories, Inc.
![Standardized Bermuda Grass (Cynodon Dactylon) Injection Standardized Kentucky Blue (June) Grass (Poa Pratensis) Injection Standardized Meadow Fescue Grass (Festuca Elatior) Injection Standardized Orchard Grass (Dactylis Glomerata) Injection Standardized Perennial Rye Grass (Lolium Perenne) Injection Standardized Redtop Grass (Agrostis Alba) Injection Standardized Sweet Vernal Grass (Anthoxanthum Odoratum) Injection Standardized Timothy Grass (Phleum Pratense) Injection [Allermed Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Bermuda Grass | Allermed Laboratories, Inc.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The product should be discarded if discoloration or particles are observed.
Table 4. Directions for diluting standardized grass pollen extract containing 10,000 BAU/mL.* Extract mL Extract mL Diluent Dilution Strength Dilution Label * If 100,000 BAU/mL extract is used to prepare dilutions, the 100,000 BAU/mL extract should be diluted 1:10 v/v before the directions shown in the table are followed. 10,000 BAU/mL
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 occurring 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 puncture 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 PHARMACOLOGY. If the puncture test to 10,000 BAU/mL extract is negative, the test may be repeated using 100,000 BAU/mL extract. Appropriate positive and negative controls for skin test interpretation are necessary. Reactions are quantified based on size of erythema and wheal in relation to controls.
INTRADERMAL TEST: An intradermal test should only be performed after a puncture test has been properly administered with a negative result. It is usually safe to initiate intradermal testing with a 1:1,000 v/v dilution of the extract to which a negative puncture test was observed. For example, if a puncture test is done with 10,000 BAU/mL extract and is negative, the intradermal test may be performed with 0.05 mL of 10 BAU/mL extract. The dose may be increased to 0.05 mL of 100 BAU/mL extract if the intradermal test with 10 BAU/mL extract is negative.
THERAPEUTIC USE: The dosage of grass pollen extract administered by subcutaneous injection during immunotherapy is highly individualized and varies according to the patient. In patients who appear to be highly sensitive by history and skin test, the initial dose of the extract should be low, such as 0.1 mL of a 0.01 BAU/mL dilution. The amount of extract is increased at each injection, but not more than 50%-100% of the previous amount, and the next increment is governed by the response to the last injection. Local reactions that persist longer than 24 hours are undesirable and any systemic reaction is an indication that the dose should be reduced (at least 50%). The upper limits of dosage have not been established, but doses larger than 0.2 mL of concentrate containing 50% glycerol may be painful due to the glycerol in the extract. The potency of each standardized grass pollen in a final mixture should not exceed that obtained from using a 10,000 BAU/mL stock concentrate of each grass included in the mix. Concentrate containing 100,000 BAU/mL should be diluted to 10,000 BAU/mL before being used to prepare final mixtures, or alternatively, the volume of 100,000 BAU/mL extract added to the mixture should be reduced 10-fold.
The optimum interval between doses of grass pollen extract has not been definitely established. However, as is customarily practiced, injections are given one or two times per week until the maintenance dose is reached. At this time, the injection interval may be increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 50% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made, depending on the amount of time that has elapsed since the last injection. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced 75% [one-quarter (25%) of the previous dose administered from the old lot of extract].
A period of three to five years of injection therapy constitutes an average course of treatment.
Children and geriatric patients appear to tolerate injections of allergenic extract well, and no special recommendations need to be made for these groups (see PRECAUTIONS - PEDIATRIC USE).
PREPARING DILUTIONS: To prepare dilutions for intradermal skin tests and therapeutic use, the stock concentrate may be diluted as shown in Table 4. Vial #1 is made by adding 1.0 mL of the concentrate to 9.0 mL of sterile diluent. This process is repeated until the desired concentration is achieved. Each new dilution is made by adding 1.0 mL of the previous dilution to 9.0 mL of sterile diluent. The number of allergy units per mL in each dilution is shown in Table 4.
1.0
9.0
1,000 BAU/mL
A
Dilution A
1.0
9.0
100 BAU/mL
B
Dilution B
1.0
9.0
10 BAU/mL
C
Dilution C
1.0
9.0
1.0 BAU/mL
D
Dilution D
1.0
9.0
0.1 BAU/mL
E
Dilution E
1.0
9.0
0.01 BAU/mL
F
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