Standardized Cat Pelt

Jubilant HollisterStier LLC
Jubilant HollisterStier LLC

ALLERGENIC EXTRACT STANDARDIZED CAT PELT AP ACETONE PRECIPITATED

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNINGS
• STANDARDIZED CAT PELT DESCRIPTION
• CLINICAL PHARMACOLOGY
• STANDARDIZED CAT PELT INDICATIONS AND USAGE
• STANDARDIZED CAT PELT CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • 1. GENERAL
  • 2. INFORMATION FOR PATIENTS
  • 3. DRUG INTERACTIONS
  • 4. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
  • 5. PREGNANCY
  • 6. NURSING MOTHERS
  • 7. PEDIATRIC USE
  • 8. GERIATRIC USE
• STANDARDIZED CAT PELT ADVERSE REACTIONS
• OVERDOSAGE
• STANDARDIZED CAT PELT DOSAGE AND ADMINISTRATION
  • (4) PEDIATRIC USE
  • (5) GERIATRIC USE
• HOW SUPPLIED
• STORAGE
• LIMITED WARRANTY
• REFERENCES

FULL PRESCRIBING INFORMATION

STANDARDIZED CAT PELT DESCRIPTION

Allergenic extracts for subcutaneous injection and prick or puncture for diagnosis are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Pelt is available as an extract from acetone precipitated source material in two different extraction fluids described below.

Source Material:
Cat Pelt source material consists of hair and whole epidermis which have undergone an acetone precipitation process. AP™ Acetone Precipitated Cat Pelt is derived from precipitate formed when acetone is added to an aqueous extract.

Extracting Fluids:
Glycero-Coca's: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative.

Product Concentration:
1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 - 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID₅₀EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL).
Each lot of Standardized Cat Pelt extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S.
Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL.
It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Pelt is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference.

2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength.

Should the physician choose to calculate the actual strength of each component in the "Concentrate" mixture, the following formulation may be used:

Ingredients:
Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative.

CLINICAL PHARMACOLOGY

13 The mechanisms by which hyposensitization is achieved are not completely understood. It has been shown that repeated injections of appropriate allergenic extracts will ameliorate the intensity of allergic symptoms upon contact with the allergen.6, 7, 8, 9 Clinical studies which address the efficacy of immunotherapy are available. The allergens which have been studied are cat, mite, and some pollen extracts.10, 11, 12, 13, 14, 15 IgE antibodies bound to receptors on mast cell membranes are required for the allergic reaction, and their level is probably related to serum IgE concentrations. Immunotherapy has been associated with decreased levels of IgE, and also with increases in allergen specific IgG "blocking" antibody. The histamine release response of circulating basophils to a specific allergen is reduced in some patients by immunotherapy, but the mechanism of this change is not yet clear. The relationships among changes in blocking antibody, reaginic antibody, and mediator-releasing cells, and successful immunotherapy need study and clarification.

STANDARDIZED CAT PELT INDICATIONS AND USAGE

STANDARDIZED CAT PELT CONTRAINDICATIONS

There are no known absolute contraindications to immunotherapy. 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
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

See WARNINGS at the beginning of this instruction sheet. Allergenic extract should be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma; (2) infection or flu accompanied by fever; or (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. Do not start immunotherapy during a period of symptoms due to exposure. Since the individual components of the extract are those to which the patient is allergic, and to which s/he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly when the antigen load from exposure plus the injected antigen exceeds the patient's antigen tolerance.

PRECAUTIONS

1. GENERAL

2. INFORMATION FOR PATIENTS

3. DRUG INTERACTIONS

4. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

5. PREGNANCY

6. NURSING MOTHERS

7. PEDIATRIC USE

8. GERIATRIC USE

STANDARDIZED CAT PELT ADVERSE REACTIONS

1. Local Reactions
Some erythema, swelling or pruritus at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours. Local reactions (erythema or swelling) which exceed 4-5 cm in diameter are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again. Large persistent local reactions may be treated by local cold, wet dressings and/or the use of oral antihistamines. They should be considered a warning of possible severe systemic reactions and an indication of the need for temporarily reduced dosages. A mild burning immediately after the injection is to be expected. This usually leaves in 10 to 20 seconds.

2. Systemic Reactions
With careful attention to dosage and administration, systemic reactions occur infrequently, but it cannot be overemphasized that in sensitive individuals, any injection could result in anaphylactic shock. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. Other possible systemic reactions which may occur in varying degrees of severity are laryngeal edema, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low. 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.

EPINEPHRINE DOSAGE
ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.
After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Airway patency should be insured. Oxygen should be given by mask. Intravenous antihistamine, theophylline and/or corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given.
Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures [Ref. J. Allergy and Clinical Immunology, 77(2):p. 271-273, 1986].
Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.
Severe systemic reactions mandate a decrease of at least 50% in the next dose, followed by cautious increases. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose.

3. Adverse Event Reporting
Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1 (800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH program. Preprinted forms (FDA Form 3500) are available from the FDA by calling 1 (800) FDA-1088. Completed forms should be mailed to MEDWATCH, 5600 Fisher Lane, Rockville, MD 20852-9787 or Fax to: 1 (800) FDA-0178.

OVERDOSAGE

See ADVERSE REACTIONS Section.

STANDARDIZED CAT PELT DOSAGE AND ADMINISTRATION

(4) PEDIATRIC USE

(5) GERIATRIC USE

HOW SUPPLIED

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. Oct. 1993.
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, pp. 107-112, 1967.
17. Sherman, W.B. Hypersensitivity Mechanism and Management. W.B. Sanders. Philadelphia, pp. 169-172, 1968.
18. Swineford, O. Asthma and Hay Fever. Charles C. Thomas. Springfield, IL, pp. 148-155, 1971.
19. Pauli, G., J.C. Bessot, R. Thierry, A. Lamensons. Correlation between skin tests, inhalation tests and specific IgE in a study of 120 subjects to house dust and D. pteronyssinus. Clin. Allergy. :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.
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24. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
25. Andersson, M. 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.
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