Allergen Pack Timothy Grass Solution Recall
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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.
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FDA Safety Alerts
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FDA Labeling Changes
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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).
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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.