Standardized Cat Hair
Jubilant HollisterStier LLC
Jubilant HollisterStier LLC
ALLERGENIC EXTRACT STANDARDIZED CAT HAIR AP Acetone Precipitated
FULL PRESCRIBING INFORMATION: CONTENTS*
- WARNINGS
- STANDARDIZED CAT HAIR DESCRIPTION
- CLINICAL PHARMACOLOGY
- STANDARDIZED CAT HAIR INDICATIONS AND USAGE
- STANDARDIZED CAT HAIR CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- STANDARDIZED CAT HAIR ADVERSE REACTIONS
- OVERDOSAGE
- STANDARDIZED CAT HAIR DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- LIMITED WARRANTY
- REFERENCES
FULL PRESCRIBING INFORMATION
WARNINGS
This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction.
Allergenic extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death.1 Therefore, emergency measures and personnel trained in their use must 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.
This standardized extract may be more potent than regular extracts and therefore is not directly interchangeable with Jubilant HollisterStier LLC non-standardized extracts, or other manufacturers’ products. Standardized pelt and hair extracts are manufactured from different source materials and are not interchangeable. Standardized cat extracts labeled in AU/mL are not interchangeable with extracts labeled in BAU/mL. See DESCRIPTION Section.
This product should never be injected intravenously.
Refer also to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections for further discussion.
STANDARDIZED CAT HAIR DESCRIPTION
Source Material:
Extracting Fluid:
Product Concentration:
1. Bioequivalent Allergy Units50232
2. Concentrate.
| e.g. |
Concentrate |
| 50% |
Short Ragweed 1:20 w/v |
| 25% |
Std. Cat Hair 10,000 BAU/mL |
| 25% |
Std. Mite D. farinae 10,000 AU/mL |
| Actual Allergen Strength in Concentrate Mixture |
= |
Allergen Manufacturing Strength |
x |
% Allergen in Formulation (by volume or parts |
CLINICAL PHARMACOLOGY
136, 7, 8, 910, 11, 12, 13, 14, 15STANDARDIZED CAT HAIR INDICATIONS AND USAGE
3, 16, 17, 18 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.19, 20
The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen.
Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc.
Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.
STANDARDIZED CAT HAIR CONTRAINDICATIONS
There are no known absolute contraindications to immunotherapy. However, see PRECAUTIONS for pregnancy risks.
Patients with cardiovascular diseases or pulmonary diseases such as symptomatic asthma, and/or those who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.1
Treat patients only with allergens to which they are allergic as shown by skin test reaction, have a history of symptoms on exposure to the allergen, and are likely to be exposed again. Any injections, including immunotherapy, should be avoided in patients with a bleeding tendency.
Since there are differences of opinion concerning the possibility of routine immunizations exacerbating autoimmune diseases, immunotherapy should be given cautiously to patients with autoimmune diseases and only if the risk from exposure is greater than the risk of exacerbating the autoimmune process.
WARNINGS
WARNINGSPRECAUTIONS DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATIONADVERSE REACTIONS
DOSAGE AND ADMINISTRATION ADVERSE REACTIONS
PRECAUTIONS
(1) General
Concentrated extracts must be diluted prior to use: See DOSAGE AND ADMINISTRATION Section below for detailed instructions on the dilution of allergenic extracts.
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.
Allergenic extracts diluted with sterile Albumin Saline with Phenol (0.4%) diluent may be more potent than extracts diluted with diluents which do not contain stabilizers. When changing from non-stabilized to stabilized diluent, consider weaker initial dilutions for both intradermal testing and immunotherapy.
Sterile solutions, vials, syringes, etc. should be used and aseptic precautions observed in making dilutions.
To avoid cross-contamination, do not use the same needle to withdraw materials from vials of more than one extract, or extract followed by diluent.
A sterile tuberculin syringe graduated in 0.01 mL units should be used to measure each dose from the appropriate dilution. Aseptic techniques should always be employed when injections of allergenic extracts are being administered.
A separate sterile syringe should be used for each patient to prevent transmission of serum hepatitis and other infectious agents from one person to another.
Patient reactions to previous injections should be reviewed before each new injection. A conservative dosage schedule should be followed by the physician until a pattern of local responses is established which can be used to monitor increases in dosage.
Rarely, a patient is encountered who develops systemic reactions to minute doses of allergen and does not demonstrate increasing tolerance to injections after several months of treatment. If systemic reactions or excessive local responses occur persistently at very small doses, efforts at immunotherapy should be stopped.
PATIENTS SHOULD BE OBSERVED IN THE OFFICE FOR 30 MINUTES AFTER EACH TREATMENT INJECTION. Most severe reactions will occur within this time period, and rapid treatment measures should be instituted. See ADVERSE REACTIONS Section for such treatment measures.
(2) Information for Patients
Patients should be instructed in the recognition of adverse reactions to immunotherapy, and in particular, to the symptoms of shock. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.
(3)Drug Interactions
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.5
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.24 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.24, 25
Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing. 26 Topical local anesthetics may suppress the fl are responses and should be avoided in skin test sites.27
(4) Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.
(5) Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.
For women who have been getting maintenance doses of allergen without side effect, the occurrence of pregnancy is not an indication to stop immunotherapy.
(6) Nursing Mothers
There are no current studies on secretion of the allergenic extract components in human milk or effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
(7) Pediatric Use
Since dosage for the pediatric population is the same as for adults 3,4 the larger volumes of solution may produce excessive discomfort. Therefore, in order to achieve the total dose required, the volume
of the dose may need to be divided into more than one injection per visit.
(8) Geriatric Use
The reactions from immunotherapy can be expected to be the same in elderly patients as in younger ones. Elderly patients may be more likely to be on medication that could block the effect of epinephrine which could be used to treat serious reactions, or they could be more sensitive to the cardiovascular side effect of epinephrine because of pre-existing cardiovascular disease.26
STANDARDIZED CAT HAIR ADVERSE REACTIONS
1. Local Reactions2. Systemic Reactions
1,21
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
J. Allergy and Clinical Immunology
3. Adverse Event Reporting
OVERDOSAGE
See ADVERSE REACTIONS Section
STANDARDIZED CAT HAIR DOSAGE AND ADMINISTRATION
3, 16, 17, 18(1) General
(2) Diagnosis
| Product |
Mean Sum of Wheal ± Std. Dev. (mm) |
Mean Sum of Erythema ± 1 Std. Dev. (mm) |
|---|---|---|
| Standardized Cat Hair |
15.1 ± 3.8 |
73.3 ± 14.3 |
50Intradermal Tests should be done only on patients with a negative prick or puncture test.
| Class |
Wheal Diameter |
Erythema Diameter |
Corresponding ∑E |
|---|---|---|---|
| 0 |
< 5 mm |
<5 mm |
<10 mm |
| ± |
5-10 mm |
5-10 mm |
10-20 mm |
| 1+ |
5-10 mm |
11-20 mm |
20-40 mm |
| 2+ |
5-10 mm |
21-30 mm |
40-60 mm |
| 3+ |
10-15 mm a
|
31-40 mm |
60-80 mm |
| 4+ |
>15 mm b
|
>40 mm |
>80 mm |
3) Immunotherapy
WARNINGS
| TABLE 1 TEN-FOLD DILUTION SERIES Standardized Extracts Labeled 10,000 BAU/mL |
||||
|---|---|---|---|---|
| Dilution |
Extract |
+ Diluent |
= |
BAU/mL Concentration |
| 0 |
Concentrate |
+0 mL |
= |
10,000 |
| 1 |
1 mL concentrate |
+9 mL |
= |
1,000 |
| 2 |
1 mL dilution #1 |
+9 mL |
= |
100 |
| 3 |
1 mL dilution #2 |
+9 mL |
= |
10 |
| 4 |
1 mL dilution #3 |
+9 mL |
= |
1 |
| 5 |
1 mL dilution #4 |
+9 mL |
= |
0.1 |
| 6 |
1 mL dilution #5 |
+9 mL |
= |
0.01 |
| 7 |
1 mL dilution #6 |
+9 mL |
= |
0.001 |
(4) Pediatric Use
(See PRECAUTIONS)
HOW SUPPLIED
Diagnostics:
Bulk Therapeutics,
STORAGE
LIMITED WARRANTY
REFERENCES
1. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79 (4): 660-677, April 1987.
2. Assay for Cat Allergen I. Manual of Methods, Laboratory of Allergenic Products, Center for Biologics Evaluation and Research. Sept. 1984.
3. Patterson, Roy, et al. Allergy Principles and Practice, 2nd ed. E. Middleton, Jr., C.E. Reed, E.F. Ellis, Ed. C.V. Mosby Co., St. Louis, MO, 1983, Chapter 52.
4. Levy, D.A., L.M. Lichtenstein, E.O. Goldstein, K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigation. 50:360, 1971.
5. Jacobs, R.L., G.W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy and Clin. Immunol. 68 (2): 125-127, August 1981.
6. Lowell, F.C., W. Franklin. A “double-blind” study of treatment with aqueous allergenic extracts in cases of allergic rhinitis. J. Allergy. 34 (2): 165-182, 1983.
7. Lowell, F.C., W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N. Eng. J. Med. 273 (13): 675-679, 1965.
8. Zavazal, V., A. Stajner. Immunologic changes during specific treatment of the atopic state. II. Acta. Allergol. 25 (1): 11-17, 1970.
9. Reisman, R.E., J.I. Wypych, E.E. Arbesman. Relationships of immunotherapy, seasonal pollen exposure and clinical response to serum concentrations of total IgE and ragweed-specific IgE. Int. Arch. Allergy Appl. Immunol. 48 (6): 721-730, 1975.
10. Ohman, J.L., S.R. Findlay, K. Leiterman. Immunotherapy in cat-induced asthma: double-blind trial with evaluation of in vivo and vitro responses. J. Allergy Clin. Immunol. 74:230, 1984.
11. Sundin, B., G. Lilja, V. Graff-Lonnevig, G. Hedlin, H. Heilborn, K. Norrlind, K-O Pegelow, H. Lowenstein. Immunotherapy with partially purified and standardized animal dander extracts. I Clinical results from a double-blind study on patients with animal dander asthma. J. Allergy Clin. Immunol. 77:478, 1986.
12. Chapman, M.D., T.A.E. Platts-Mills, M. Gabriel, H.K. Ng, W.G.L. Allen, L.E. Hill, A.J. Nunn. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Int. Arch. Allergy Appl. Immunol. 61: 431-440, 1980.
13. Norman, P.S. Postgraduate Course Presentation. An overview of immunotherapy, implications for the future. J. Allergy Clin. Immunol, 65 (2): 87-96, 1980.
14. Norman, P.S., W.L. Winkenwerder. Maintenance immunotherapy in ragweed hay fever. J. Allergy, 74: 273-282, 1971.
15. Norman, P.S., W.L. Winkenwerder, L.M. Lichtenstein. Immunotherapy of hay fever with ragweed Antigen E; comparisons with whole pollen extract and placebos. J. Allergy. 42: 93-108, 1968.
16. Sheldon, J.M., R.G. Lovell, K.P. Matthews. A Manual of Clinical Allergy. Second Edition. W.B. Saunders. Philadelphia, 1967, pp. 107-112.
17. Sherman, W.B. Hypersensitivity Mechanism and Management. W.B. Sanders, Philadelphia, 1968, pp. 169-172.
18. Swineford, O. Asthma and Hay Fever. Charles C. Thomas. Springfield, IL, 1971, pp. 148-155.
19. Pauli, G., J.C. Bessot, R. Thierry, A. Lamensons. Correlation between skin, inhalation tests and specific IgE in a study of 120 subjects to house dust and D. pteronyssinus. Clin. Allergy. 7:337, 1977.
20. Murray, A.B., A.C. Ferguson, B.J. Morrison. Diagnosis of house dust mite allergy in asthmatic children: What constitutes positive history? J. Allergy Clin. Immunol. 71:21, 1983.
21. Turkeltaub, Paul C., Peter J. Gergen. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: Data from the second National Health and Nutrition Examination Survey 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84 (6): 886-890, Dec. 1989.
22. Metzger, W.J., E. Turner, R. Patterson. The safety of immunotherapy during pregnancy. J. Allergy Clin. Immunol. 61 (4): 268-272. 1978.
23. Turkeltaub, Paul C., Suresh Rastogi, Harold Baer. Skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of Allergy Units to reference preparations using the ID50EAL Method. Manual of Methods, Center for Biologics Evaluation and Research. May 1986.
24. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
25. Andersson, M. and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. Journal Allergy Clinical Immunology. 79 (2): 345-349, February 1987.
26. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. Journal Allergy Clinical Immunology. 82: 752-757, November 1988.
27. Pipkorn, Ulf, M. Andersson. Topical dermal anesthesia inhibits the fl are but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987
Standardized Cat HairStandardized Cat Hair INJECTION, SOLUTION
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