Animal Allergens Injection

Warnings

This product is intended for use only by physicians who are experienced in the use of allergenic extracts, or for use under the guidance of an allergist.

Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.7 Therefore, emergency measures and personnel trained in their use should be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if symptoms occur.

Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing.

This product should never be injected intravenously.

Patients on non-selective beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.6

Refer also to the WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS Sections below for further discussion.

Scratch, prick or puncture test first. Test intradermally only to those antigens giving negative or questionable reactions on scratch, prick or puncture testing. Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to large amounts of antigen to which he or she is sensitive. Therefore, use caution when applying pollen tests to patients during their active pollen season, or after an exposure to inhalant allergens that produce symptoms. Refer to boxed WARNINGS Section.

1. General
Parenteral Drug Products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2. Intradermal Testing Methods
Cleanse the rubber stopper of the vial with liquid antiseptic before withdrawing extract. A sterile tuberculin syringe with 26-gauge, short-bevel needle should be used for the injection. The anterior surface of the upper and lower arm is preferable for testing. Cleanse the skin with soap and water or wash with alcohol or other antiseptic. Introduce the needle between the superficial layers of the skin and inject 0.02 mL of the extract. Test sites should be at least 2.5 cm apart, and no more than 10 to 20 antigens should be introduced at one time. This group can be followed with additional groups of 10, providing the reactions are not numerous or strong. The same amount of extract should be injected in each site for proper comparison. It is advisable to avoid testing with more than one allergen in the same group in each series, i.e., nuts, fish, epidermals, etc. A site should be injected with 0.02 mL of the control solution. All skin tests should be validated by appropriate positive control tests (e.g., histamine) and negative control tests [e.g., Glycerin, Albumin Saline with Phenol (0.4%), or Buffered Saline with Phenol (0.4%)]. The negative control test should be the same material as is used as a diluting fluid in the tested extracts. Diluting fluid is used in the same way as an active test extract. False positive reactions are sometimes encountered in intradermal testing, and the possibility of irritation reactions should always be taken into consideration. In cases where the patient is known to be quite sensitive, screen testing by scratch, prick or puncture method is recommended, and intradermal testing should be done with caution. The intradermal strength supplied is usually safe for testing patients presenting negative scratch, prick or puncture test reactions. It is recommended that a 1:10 dilution of the stock intradermal strength be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests.

3. Use of Antigen Mixes
The use of complicated mixes of unrelated pollens for testing is not recommended since in the case of a positive reaction it does not indicate which pollen(s) are responsible, and in the case of a negative reaction, it fails to indicate whether the individual pollens at full concentration would give a positive reaction.

4. Reading Skin Test Reactions
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity. In general, the size of wheal and erythema response correlates directly with the patient's sensitivity to that allergen.
Standardized Products
(a) Mites: The skin test concentrations of 30 AU/mL and 300 AU/mL in multiple dose vials are used for intradermal testing.
Intradermal skin test results in selected highly sensitive subjects are presented for reference purposes:

AU/mL that Elicited ∑E = 50 mm
Allergen	Number of Persons	Mean	2 Std. Dev. Range
D. farinae	12	0.0609	0.0015-2.6016
D. pteronyssinus	12	0.333	0.0003-4.0077

Intradermal extracts should be used as follows:
(1) Patients with a negative scratch, prick or puncture test: Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 30 AU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 300 AU/mL extract solution. The negative control used with this latter dilution should contain 0.5% glycerin.
(2) Patients tested only by the intradermal method: Patients suspected of being highly allergic should be tested with 0.02 to 0.05 mL of a solution containing 0.03 AU/mL. A negative test should be followed by repeat tests using progressively stronger concentrations until the maximum recommended strength of 300 AU/mL is reached. The negative control used with this latter dilution should contain 0.5% glycerin.
(b) Cat Hair and Cat Pelt: Intradermal endpoint titration (IET) tests were completed with Cat Pelt extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 (D50) mm.That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).
IET tests were completed with Cat Hair extract using 15 subjects to determine the mean concentration required to produce a ∑E of 50 mm (D50). That concentration contained 0.049 BAU/mL (range 0.006 to 0.661 BAU/mL).
Intradermal extract should be used as follows:
Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerin.
Standardized Cat Hair and Cat Pelt products are not interchangeable with each other or any other cat products including those labeled AU/mL.
(c) Ragweed pollen (Short Ragweed or Giant and Short Ragweed Mixture) Antigen E Assayed: The intradermal strength for Short Ragweed extract is usually 500 PNU, which by calculation contains approximately 0.7 to 3 units of Antigen E/mL. For Giant and Short Ragweed mix the suggested intradermal strength is 500 PNU, which by calculation contains 0.4 to 1.5 units of Antigen E/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick, or puncture tests. A study of ragweed sensitive patients9 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Antigen E concentrations of from 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL. Skin tests are graded in terms of the wheal and erythema response noted at 15 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.

5. Geriatric Use

The dose is the same in patients of all age groups. Because the wheal size in response to allergen skin testing decreases with age, appropriate histamine positive control skin tests must be performed.1

6. Pediatric Use

The dose is the same in patients of all age groups. Wheal size in response to allergen skin testing can be smaller in infants than in adults. Appropriate histamine positive control skin tests must be performed.1

Refer to the following table to determine the skin test sensitivity grade. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.

Grade	Erythema mm	Papule or Wheal mm	Coresponding mm ∑E
0	<5	<5	<10
±	5-10	5-10	10-20
1+	11-20	5-10	20-40
2+	21-30	5-10	40-60
3+	31-40	10-15 (a)	60-80
4+	>40	>15 (b)	> 80

a or with pseudopods

b or with many pseudopods

A positive skin reaction to any allergen must be interpreted in light of the patient’s history of symptoms, time of year, known exposures, and eating habits.
THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGENIC HISTORY; RATHER, THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.

Most allergens are available in multiple dose 5 mL vials at PNU, w/v, some mixes as Concentrate, Standardized Mite products at AU/mL (30 AU/mL and 300 AU/mL each species), or Standardized Grass products at BAU/mL [100 BAU/mL and 1,000 BAU/mL (Bermuda 100 BAU/mL only)]. Product labels state vials are for intradermal testing and list strengths.

The expiration date of the diagnostic extracts is listed on the container label. The extract should be stored at 2° to 8°C, and kept at this temperature range during office use.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly, and that the directions be followed carefully during use. No warranty, express or implied, including any warranty of merchantability or fitness, is made. Representatives of the Company are not authorized to vary the terms or the contents of any printed labeling, including the package insert, for this product except by printed notice from the Company’s headquarters. The prescriber and user of this product must accept the terms hereof.