Allergen Pack Timothy Grass Solution
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Questions & Answers
Side Effects & Adverse Reactions
All concentrates of Standardized Grass Pollen Extracts are manufactured to assure high potency and have the ability during skin testing and immunotherapy to cause serious local and systemic reactions including death in extremely sensitive patients. Most reactions occur within 20 minutes after injection, but may occur later.19 To minimize the potential for local or systemic reactions, the relative sensitivity of the patient must be assessed from the allergic history and from clinical observations. Patients should be informed of these risks prior to skin testing and immunotherapy. (See PRECAUTIONS and ADVERSE REACTIONS)
Concentrated extracts at 10,000 and 100,000 BAU/mL, must be diluted with a sterile diluent prior to use in a patient for intradermal testing or for immunotherapy.
Skin testing should be initiated only with 10,000 BAU/mL extracts. If several concentrated extracts at 100,000 BAU/mL are administered concurrently to a sensitive patient, the additive effects of cross-reacting allergens may cause a systemic anaphylactic reaction.
Allergenic extracts should be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist:
- severe symptoms of rhinitis and/or asthma
- infection or flu accompanied by fever
- exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection
- evidence of a local or systemic reaction to the preceding extract injection during a course of immunotherapy
The dosage must be reduced: 1) when starting a patient on fresh extract; 2) when transferring a patient from another form of extract to a BAU standardized extract; or 3) when modifying dosages or components in a mixture or an individual prescription, even though the labeled strength of the old and new vials may be the same. This reduction in dosage may be necessary: 1) due to the previously used extract having lost potency during storage; 2) due to the fact that standardized extracts labeled in BAU/mL differ in potency in comparison to nonstandardized extracts of the same species (see TABLE 3); or 3) due to different patient sensitivity to different components. The amount of new extract given should not exceed 25% of the last dose given from the old vial, assuming both extracts contain comparable amounts of allergen. Any evidence of a local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy. The information about nonstandardized extracts shown in TABLE 3 may be helpful in confirming the appropriateness of the initial dose. When a patient is first being administered a standardized extract labeled in BAU/mL, the new dose can be selected based on a side-by-side comparison with the previously used nonstandardized extract. The availability of 10,000 BAU/mL and 100,000 BAU/mL doses is intended to facilitate safe switching by providing the physicians access to lower and higher dosages.
Patients receiving beta blocker drugs may not be responsive to beta adrenergic drugs used to treat anaphylaxis. The risks of anaphylaxis in these patients should be carefully weighed against the benefits of immunotherapy.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Standardized Grass Pollen Extracts are indicated for the skin-test diagnosis of allergy and immunotherapy treatment of patients with a history of allergy to the respective pollen. The diagnosis of IgE-mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity.8,11,15 Extracts at 10,000 BAU/mL are indicated for use in scratch, prick, or puncture skin test diagnosis. Extracts at 100,000 BAU/mL are indicated for use in scratch, prick, or puncture skin test diagnosis in less sensitive subjects, such as those negative or indeterminate upon scratch, prick, or puncture testing at 10,000 BAU/mL. Extracts at 10,000 BAU/mL or 100,000 BAU/mL are indicated for intradermal skin test diagnosis only when appropriately diluted.
Immunotherapy with Standardized Grass Pollen Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens.16-18 Extracts at 10,000 BAU/mL or 100,000 BAU/mL are indicated for immunotherapy only when appropriately diluted. 10,000 BAU/mL extracts are indicated for immunotherapy on previously untreated patients. 100,000 BAU/mL extracts are indicated if a higher dose is needed. (See DOSAGE AND ADMINISTRATION) STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/mL ARE NOT INTERCHANGEABLE WITH GRASS POLLEN EXTRACTS LABELED IN AU/mL OR WITH NONSTANDARDIZED GRASS POLLEN.
EXTRACTS. The use of Standardized Grass Pollen Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).
History
There is currently no drug history available for this drug.
Other Information
Standardized Grass Pollen Allergenic Extracts are supplied as sterile solutions for intracutaneous or subcutaneous administration. Standardized Grass Pollen Allergenic Extracts include Bermuda (Cynodon dactylon), Kentucky Blue (June), (Poa pratensis), Meadow Fescue (Festuca elatior), Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Redtop (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), and Timothy (Phleum pratense). Glycerinated concentrates contain the soluble extractants of the source material with 0.25% sodium chloride, 0.27% sodium bicarbonate, and 50% glycerin v/v. All extracts contain 0.4% phenol as the preservative. Source materials for each extract are the specific pollens collected from the respective plants.
Standardized Grass Pollen Extracts are labeled in Bioequivalent Allergy Units
(BAU)/mL. STANDARDIZED GRASS POLLEN EXTRACTS LABELED IN BAU/ML ARE NOT INTERCHANGEABLE WITH GRASS POLLEN
EXTRACTS LABELED IN AU/ML OR WITH NONSTANDARDIZED
GRASS POLLEN EXTRACTS. Bioequivalent allergy units are assigned based on comparison by enzyme linked immunosorbent assay (ELISA) to references from the U. S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER References are assigned unitage based on quantitative skin testing.1-4 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 mm sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/mL, whereas references diluted 1:500,000 which elicit the same 50 mm sum of erythema diameter response are assigned 10,000 BAU/mL.
Sources
Allergen Pack Timothy Grass Solution Manufacturers
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Alvix Laboratories, Llc
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Allergen Pack Timothy Grass Solution | Alvix Laboratories, Llc
TherapyStandardized versus Nonstandardized Extracts:
Dosage with extracts standardized in BAU must be derived from a knowledge of the patient’s sensitivity to the specific pollen. Switching from an extract not standardized in BAU cannot be made by a calculated ratio. There are no equivalent dosages in bioequivalent allergy units applicable to all the grass species that can be related to previously marketed nonstandardized extracts labeled in weight-to-volume (w/v), Protein Nitrogen Units (PNU), or Allergy Units (AU). The information about nonstandardized extracts shown in TABLE 3 may be helpful in selecting the initial dose for the side-by-side skin test comparison. Patients being switched from nonstandardized extracts to extracts standardized in BAU can be reevaluated by diagnostic skin testing to judge the dose for starting immunotherapy or building up to new maintenance dosages. When a patient is first being administered a standardized extract labeled in BAU/mL, the new dose can be selected based on a side-by-side comparison with the previously used nonstandardized extract.
Immunotherapy is administered by subcutaneous injection. Dosage is individualized according to the patient’s sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. Extracts for immunotherapy must be prepared by diluting the concentrate with sterile diluent (such as normal or buffered saline, or normal saline with human serum albumin).
The initial dose of an extract in BAU should be calculated based on the puncture test reactivity. Note in TABLE 1 and TABLE 2 the puncture and intradermal skin test reactivity of sensitive subjects evaluated with the US reference extracts.
The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (0.0005 to 0.005 BAU) (dilution 5 or 6 in TABLE 4 below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution (0.05 to 0.5 BAU).
The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in
the subsequent dose. The upper limits of dosage in BAU have not been established. Doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosages of allergenic extracts do not vary significantly with the allergic disease under treatment.
To prepare dilutions starting from a 100,000 BAU/mL concentrate, proceed as in TABLE 4. The 50,000 BAU/mL concentrate can be made by using equal parts of the 100,000 BAU/mL extract and the sterile diluent. The ten-fold dilution series uses 0.5 mL of concentrate to 4.5 mL of sterile diluent with additional dilutions made in the same manner.
TABLE 4: Ten-Fold Dilution Series Dilution Exract Diluent BAU/mL Concentration BAU/mL 0 Concentrate 100,000 10,000 1 0.5 mL concentrate 4.5 mL 10,000 1,000 2 0.5 mL dilution 1 4.5 mL 1,000 100 3 0.5 mL dilution 2 4.5 mL 100 10 4 0.5 mL dilution 3 4.5 mL 10 1 5 0.5 mL dilution 4 4.5 mL 1 0.1 6 0.5 mL dilution 5 4.5 mL 0.1 0.01*Due to differences such as source material, preservative, potency dilutions, storage conditions, and length of storage, there is no common potency correlation ratio between extracts standardized in Bioequivalent Allergy Units (BAU) and: 1) standardized extracts previously labeled in Allergy Units (AU); 2) nonstandardized extracts labeled weight-to-volume (w/v); 3) nonstandardized extracts labeled in Protein Nitrogen Units (PNU); or 4) alum-precipitated extracts.
The optimal interval between doses of allergenic extracts has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval is then increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient’s sensitivity. 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 to 25% of the previous dose.
The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some concentrated extracts naturally develop a cloudy appearance over time under refrigeration, the material settling to the bottom on standing.
TherapyStandardized versus Nonstandardized Extracts:
Dosage with extracts standardized in BAU must be derived from a knowledge of the patient’s sensitivity to the specific pollen. Switching from an extract not standardized in BAU cannot be made by a calculated ratio. There are no equivalent dosages in bioequivalent allergy units applicable to all the grass species that can be related to previously marketed nonstandardized extracts labeled in weight-to-volume (w/v), Protein Nitrogen Units (PNU), or Allergy Units (AU). The information about nonstandardized extracts shown in TABLE 3 may be helpful in selecting the initial dose for the side-by-side skin test comparison. Patients being switched from nonstandardized extracts to extracts standardized in BAU can be reevaluated by diagnostic skin testing to judge the dose for starting immunotherapy or building up to new maintenance dosages. When a patient is first being administered a standardized extract labeled in BAU/mL, the new dose can be selected based on a side-by-side comparison with the previously used nonstandardized extract.
Immunotherapy is administered by subcutaneous injection. Dosage is individualized according to the patient’s sensitivity, the clinical response, and tolerance to the extract administered during the early phases of an injection regimen. Extracts for immunotherapy must be prepared by diluting the concentrate with sterile diluent (such as normal or buffered saline, or normal saline with human serum albumin).
The initial dose of an extract in BAU should be calculated based on the puncture test reactivity. Note in TABLE 1 and TABLE 2 the puncture and intradermal skin test reactivity of sensitive subjects evaluated with the US reference extracts.
The initial dose of the extract may be as low as 0.1 mL of a 0.005 to 0.05 BAU/mL dilution (0.0005 to 0.005 BAU) (dilution 5 or 6 in TABLE 4 below) or even less for the exquisitely sensitive patient. Patients with lesser sensitivity may be started at 0.1 mL of a 0.5 to 5 BAU/mL dilution (0.05 to 0.5 BAU).
The amount of allergenic extract is increased at each injection by no more than 50% of the previous amount, and the next increment is governed by the response to the last injection. Large local reactions which persist for longer than 24 hours are generally considered an indication for repeating the previous dose or reducing the dose at the next administration. Any evidence of systemic reaction is an indication for a reduction of 75% in
the subsequent dose. The upper limits of dosage in BAU have not been established. Doses larger than 0.2 mL of an extract in 50% glycerin may cause discomfort upon injection. The dosages of allergenic extracts do not vary significantly with the allergic disease under treatment.
To prepare dilutions starting from a 100,000 BAU/mL concentrate, proceed as in TABLE 4. The 50,000 BAU/mL concentrate can be made by using equal parts of the 100,000 BAU/mL extract and the sterile diluent. The ten-fold dilution series uses 0.5 mL of concentrate to 4.5 mL of sterile diluent with additional dilutions made in the same manner.
TABLE 4: Ten-Fold Dilution Series Dilution Exract Diluent BAU/mL Concentration BAU/mL 0 Concentrate 100,000 10,000 1 0.5 mL concentrate 4.5 mL 10,000 1,000 2 0.5 mL dilution 1 4.5 mL 1,000 100 3 0.5 mL dilution 2 4.5 mL 100 10 4 0.5 mL dilution 3 4.5 mL 10 1 5 0.5 mL dilution 4 4.5 mL 1 0.1 6 0.5 mL dilution 5 4.5 mL 0.1 0.01*Due to differences such as source material, preservative, potency dilutions, storage conditions, and length of storage, there is no common potency correlation ratio between extracts standardized in Bioequivalent Allergy Units (BAU) and: 1) standardized extracts previously labeled in Allergy Units (AU); 2) nonstandardized extracts labeled weight-to-volume (w/v); 3) nonstandardized extracts labeled in Protein Nitrogen Units (PNU); or 4) alum-precipitated extracts.
The optimal interval between doses of allergenic extracts has not been established. Injections usually are given 1 or 2 times per week until the maintenance dose is reached. The injection interval is then increased to 2 weeks, then to 3 weeks and finally to 4 weeks. If the patient does not return for 6 to 8 weeks, the dose should be reduced to 25% of the last dose. If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made considering the components and the patient’s sensitivity. 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 to 25% of the previous dose.
The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Some concentrated extracts naturally develop a cloudy appearance over time under refrigeration, the material settling to the bottom on standing.
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