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Side Effects & Adverse Reactions
See boxed WARNINGS at the beginning of this information sheet.
Do not administer allergenic extract injections intravenously. Patients should always be observed for at least 20 to 30 minutes after any skin test or injection. Concentrated allergenic extracts should be diluted with Sterile Diluent for Allergenic Extract prior to use for intradermal testing and for immunotherapy preparation. Systemic reactions may occur infrequently and may range from mild exaggeration of the patient’s allergic symptoms to urticaria, rhinitis, conjunctivitis, angioedema, cough, wheezing, fainting, pallor, bradycardia, hypotension, or even, in extremely sensitive individuals, to anaphylactic shock and death. Have epinephrine 1:1,000 readily available in case of a reaction. Emergency measures and personnel trained for medical emergencies should be immediately available in the event of a life-threatening reaction. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. Patients taking beta-blocker medication may not respond to the usual dose of epinephrine.
Diagnostic testing as well as immunotherapy should be temporarily withheld from patients or the dose reduced until cause of reaction is evaluated by prescribing physician if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma, (2) infection or flu accompanied by fever, (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection, and (4) systemic reaction to previous injection.
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FDA Safety Alerts
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FDA Labeling Changes
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Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.
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Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract.
|Therapeutic and Scratch extracts:||Intradermal 1:500 v/v (foods)||Intradermal 1:1,000 v/v (pollens, molds, epidermals, inhalants)|
|Glycerin, USP, 50% v/v||Glycerin, USP, 0.1% v/v||Glycerin, USP, 0.05% v/v|
|Sodium chloride, USP, 0.166% w/v||Sodium chloride, USP, 0.9% w/v||Sodium chloride, USP, 0.9% w/v|
|Sodium bicarbonate, USP, 0.091% w/v||Sodium bicarbonate, USP, 0.000182% w/v||Sodium bicarbonate, USP, 0.000091% w/v|
|Phenol, USP, 0.4% w/v||Phenol, USP, 0.4% w/v|
|Sterile Diluent for Allergenic Extract:|
|Normal Saline with Phenol:||Human Serum Albumin:||Glycerin, USP, 50% w/v|
|Sodium chloride, USP 0.9% w/v||Sodium chloride, USP 0.9% w/v||Sodium bicarbonate, USP 0.091% w/v|
|Phenol, USP 0.4% w/v||Phenol, USP 0.4% w/v||Sodium chloride, USP 0.166% w/v|
|Water for Injection, USP q.s.||Normal Serum Albumin (Human), 0.03% w/v||Water for Injection, USP, q.s.|
|Air replaced with Nitrogen, NF||Water for Injection, USP q.s.|
|Air replaced with Nitrogen, NF|
The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito
The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.