Standardized Cat Hair 10000 [BAU]/mL Injection, Solution, 30 mL — NDC 65044-4815-3 (Billing 65044-4815-03)

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 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. THE CONCENTRATE SHOULD NOT BE INJECTED AT ANY TIME UNLESS TOLERANCE HAS BEEN ESTABLISHED. DILUTE CONCENTRATED EXTRACTS WITH STERILE DILUENT FOR INTRADERMAL TESTING.

INJECTIONS SHOULD NEVER BE GIVEN INTRAVENOUSLY. Subcutaneous injection is recommended. Intracutaneous or intramuscular injection may produce large local reactions or be excessively painful.

AFTER INSERTING NEEDLE SUBCUTANEOUSLY, BUT BEFORE INJECTING, ALWAYS WITHDRAW THE PLUNGER SLIGHTLY. IF BLOOD APPEARS IN THE SYRINGE, CHANGE NEEDLE AND GIVE THE INJECTION IN ANOTHER SITE. IF CHANGING FROM HAIR TO PELT EXTRACTS OR VICE-VERSA: Hair and pelt extracts differ in their non Fel d 1 allergens and are not interchangeable.

Therefore, if patients are switched from one type of cat extract to another, the initial dose should be based on skin tests as noted under DOSAGE AND ADMINISTRATION , 3. Immunotherapy. IF THE PREVIOUS EXTRACT WAS NON-STANDARDIZED OR WAS STANDARDIZED AND LABELED IN ALLERGY UNITS PER mL (AU/mL): This standardized extract may be more potent than non-standardized extracts.

Initiate therapy as though patient had not been receiving immunotherapy, or determine initial dose by skin test using serial dilutions of the extract. See PRECAUTIONS and DOSAGE AND ADMINISTRATION Sections. IF CHANGING TO A DIFFERENT LOT OF JUBILANT HOLLISTERSTIER EXTRACT: Even though it is the same formula and concentration, the first dose of the new extract should not exceed 50% of the last administered dose from the previous extract.

IF THE EXTRACT PREVIOUSLY USED WAS FROM ANOTHER MANUFACTURER: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be insured. The starting dose of the extract therefore should be greatly decreased even though the extract is the same formula and dilution. Initiate therapy as though patient had not been receiving immunotherapy, or determine initial dose by skin test using serial dilutions of the extract.

See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS Sections. IF A PROLONGED PERIOD OF TIME HAS ELAPSED SINCE THE LAST INJECTION: Patients may lose tolerance for allergen injections during prolonged periods between doses. The duration of tolerance is an individual characteristic and varies from patient to patient.

In general, the longer the lapse in the injection schedule, the greater dose reduction required. If the interval since last dose is over four weeks, perform skin tests to determine starting dose. IF THE PREVIOUS EXTRACT WAS OUTDATED: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under refrigerated storage conditions (2° - 8° C).

During the storage of extracts, even under ideal conditions, some loss of potency occurs. For this reason, extracts should not be used beyond their expiration date. If a patient has been receiving injections of an outdated extract, he may experience excessive local or systemic reactions when changed to a new, and possibly more potent, extract.

In general, the longer the material has been outdated, the greater the dose reduction necessary for the fresh extract. IF CHANGING FROM ALUM-ADSORBED TO AQUEOUS OR GLYC… [Excerpted — this section continues on DailyMed.]

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 must 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… [Excerpted — this section continues on DailyMed.]

(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

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… [Excerpted — this section continues on DailyMed.]