Allergenic Extract
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Questions & Answers
Side Effects & Adverse Reactions
The only approved method for determining hypersensitivity to Allermed Laboratories Allergenic Extracts is by diagnostic skin testing (See DOSAGE AND ADMINISTRATION — DIAGNOSIS).
Physicians who administer allergenic extract should have emergency medication and equipment available to treat anaphylaxis14. See Precautions, Adverse Reactions and Overdosage below.
To reduce the risk of anaphylaxis, the following measures must be observed:
- Concentrated extract must be diluted before use for intradermal skin testing and for beginning immunotherapy. It should never be injected intravenously during testing or treatment procedures.
- Patients who are highly sensitive, determined from clinical findings and test results, may require that treatment start with a very weak concentration of extract, such as 1:10,000,000 v/v.
- The dosage of fresh (new) extract given to a patient receiving maintenance injections must be reduced to one-fourth the amount given from the previous (old) lot (See Immunotherapy, last paragraph).
- Patients who are transferred to standardized extract after previous treatment with unstandardized extract must be skin tested with serial dilutions, starting with a 1:100,000 v/v dilution of the standardized extract, to determine a safe, non-reacting starting dose.
- Patients who are transferred to this extract after treatment with alum precipitated or other modified extract must re-start injections with the beginning recommended dose of this extract.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease.4,5,6
Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms.7-12
Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.
History
There is currently no drug history available for this drug.
Other Information
Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.
Sources
Allergenic Extract Manufacturers
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Allermed Laboratories, Inc.
![Allergenic Extract [Allermed Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Allergenic Extract | Allermed Laboratories, Inc.
Diagnosis: Concentrated extract may be used for scratch or prick testing providing the patient is not extremely sensitive. In this case, the extract should be diluted 10 fold before a scratch or prick test is performed. Extract for intradermal testing must be used as follows:
Table 1 - Suggested Dosage Schedule No.
a. Patients with a negative scratch or prick test: Patients who do not react who do not react to a valid scratch or prick test should be tested intradermally with 0.05 mL of a 1:1000 v/v dilution of the concentrate. If the test is negative, a second test should be performed with 0.05 mL of a 1:100 v/v dilution or concentrate.
b. Patients with positive scratch or prick tests: It is not advisable to perform an intradermal skin test if the patient has a positive scratch or prick test.
c. Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.05 mL of a 1:100,000 v/v dilution of the concentrate. A negative test should be followed by repeat tests using 10 fold stronger concentrations until the maximum dose of 0.05 mL of a 1:100 v/v dilution is reached.
Interpretation of Results
Scratch and Prick Test
A negative test shows only a slight red area at the site of scarification or prick penetration. Positive tests are scored as follows:
1+ Erythema with 5 mm wheal
2+ Erythema with a 5-10 mm wheal
3+ Erythema with a 10-15 mm wheal
4+ Erythema with a wheal 15 mm (or larger) with pseudopodia
Intradermal Test
A negative test shows no change in the appearance and size of the 5 mm wheal created by the I.D. injection of 0.05 mL of extract. Positive tests are scored as follows:
1+ Erythema 10-20 mm with a 5-10 mm wheal
2+ Erythema 20-30 mm with a 5-10 mm wheal
3+ Erythema 30-40 mm with a 10-15 mm wheal
4+ Erythema greater than 40 mm with a 15 mm wheal (or larger) with pseudopodia
Immunotherapy
Allergenic extract should be administered subcutaneously in the outer aspect of the upper arm using a sterile tuberculin syringe and needle. The skin should be cleaned with 70% alcohol and aseptic technique should be observed in removing the extract from the vial. Care must be taken to avoid injecting the extract into a blood vessel because of the risk of anaphylaxis.
Concentrated extract must be diluted before administration to new patients. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. However, as a precaution against overdose, a skin test with the intended starting dose should be done to help evaluate the patient's sensitivity to the product. If the skin response is larger than 5 mm edema/15 mm erythema, the extract is too strong and must be diluted before it is given subcutaneously. The doses shown in the Dosage Schedule (Table 1) below are recommended unless the patient's skin test response and allergic history indicates that more dilute extract should be used.
Little is known about the required accumulated dosage of allergen that is needed to relieve symptoms. However, studies have shown that high dose immunotherapy is efficacious in the treatment of allergic rhinitis and asthma. For this reason, treatment with extract from Vial #5 is recommended, providing the patient can tolerate the extract without experiencing local or systemic reactions. Treatment with Vial #6 may be used for patients who have not had adverse reactions to extract in Vial #5 and who require more concentrated extract to control or relieve symptoms.
Patients who have received allergenic extract for maintenance therapy SHOULD NOT be given the same dose from a fresh vial of extract. IT IS ADVISABLE TO REDUCE THE DOSAGE OF FRESH EXTRACT TO ONE-FOURTH THE AMOUNT GIVEN FROM A PREVIOUS LOT OF EXTRACT MADE AT THE SAME CONCENTRATION AND BY THE SAME FORMULA.
Vial #1
1:100,000 w/v
frequency twice
weekly
mL
Vial #2
1:10,000 w/v
frequency twice
weekly
mL
Vial #3
1:1,000 w/v
frequency once
weekly
mL
Vial #4
1:100 w/v
frequency once
weekly
mL
Vial #5
1:10 w/v
frequency every
two-four weeks
mL
Vial #6
Concentrate
frequency every
two-four weeks
mL
1
0.025
0.025
0.025
0.025
0.025
0.025
2
0.05
0.05 0.05 0.05 0.05 0.05 3
0.10
0.10
0.10
0.10
0.10
0.10
4
0.15
0.15
0.15
0.15
0.15
0.15
5
0.20
0.20
0.20
0.20
0.20
0.20
6
0.25
0.25
0.25
0.25
0.25
0.25
7
0.30
0.30
0.30
0.30
0.30
0.30
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