Data from FDA - Curated by EPG Health - Last updated 13 January 2017

Indication(s)

INDICATIONS AND USAGE Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.

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Advisory information

contraindications
CONTRAINDICATIONS Conditions under which the administration of allergenic extract may be contraindicated, depending upon individual circumstances, include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may be less able to tolerate the life-threatening effects of a serious adverse reaction. ASTHMA - Patients with highly unstable asthma are at greater risk of fatal reactions from skin tests than are patients without asthma, especially during seasonal exacerbations of the disease. Also, the combination of unstable asthma and treatment with B-adrenergic blockers appears to increase this risk5. Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: 1) severe symptoms of hay fever and/or asthma; 2) infection or flu accompanied by fever; and 3) exposure to excessive amounts of clinically relevant allergen(s) prior to skin testing.
Special warnings and precautions
PRECAUTIONS GENERAL It is recommended that the device used to perform skin tests be disposable to prevent the possibility of accidental transfer of serum hepatitis, HIV and other infectious agents from one person to another. Injectable epinephrine should be available when skin tests are administered (see ADVERSE REACTIONS). PATIENT INFORMATION Skin tests with allergenic extracts are usually safe and effective in the diagnosis of allergic diseases when used properly and when interpreted in conjunction with the allergic history and clinical findings. Patients should be observed in the office for 20 minutes after skin tests have been completed9 and instructed to return to the office or emergency room if symptoms of an allergic reaction or shock occur. The risk of a serious adverse reaction is always present. However, it is minimized by the use of the prick-puncture procedure as the initial method of testing. In a study of 16,204 persons in the United States between 6 and 74 years of age, no anaphylactic reactions were observed after prick-puncture skin testing with eight different allergenic extracts. The authors concluded that the risk of adverse reactions to prick-puncture skin tests is low and similar to other routine medical procedures, such as venipuncture10. Since drugs may affect the reactivity of the skin, patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs prior to skin testing (see DRUG INTERACTION below). DRUG INTERACTION Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse reaction11. Since drugs may affect the reactivity of the skin, patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs for at least 24 hours prior to skin testing. Non-sedating antihistamine suppresses the erythema/edema response for longer periods and should be withheld according to information included in the package insert. Adrenal corticosteroids and ACTH do not alter the immediate hypersensitivity reaction of the skin but do reduce delayed-type reactions associated with cellular hypersensitivity. 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. PREGNANCY CATEGORY C Allergenic Extracts. 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. Since studies indicate no increased risk to the fetus or to the mother who is treated cautiously with immunotherapy during a normal pregnancy, it is unlikely that extract administered by skin test will be harmful. However, on the basis of histamine's known ability to contract uterine muscle, extensive testing with its possibility of histamine release should be avoided during pregnancy. Also, immunologic suppressive action can occur during pregnancy and for this reason it is possible that the results of allergy skin tests may not accurately reflect the allergic state of the pregnant patient12. NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extract is administered to a nursing woman. PEDIATRIC USE The procedures and precautions that are observed in skin testing adults should be observed with children13.
Adverse reactions
ADVERSE REACTIONS LOCAL REACTIONS Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral anti-histamines. SYSTEMIC REACTIONS Allergenic extracts are highly potent and in highly sensitive individuals can cause systemic symptoms, including anaphylaxis. It cannot be overemphasized that anaphylactic shock is always a possibility under certain unpredictable combinations of circumstances. Other possible systemic reaction symptoms may include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. Therefore, it is imperative that physicians administering skin tests understand and be prepared to treat severe allergic reactions. If a systemic or anaphylactic reaction occurs during or following skin testing, the patient should be treated with 1:1000 epinephrine hydrochloride. The recommended dose: infants to 2 years of age 0.05 to 0.1 mL, children 2 to 6 years, 0.15 mL, children 6 to 12 years, 0.2 mL, adults 0.3 - 0.5 mL. If necessary, treatment may be repeated up to three times every 10 - 15 minutes. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, aminophylline, inhaled bronchodilators or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately. The physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment is of utmost importance14. Serious adverse reactions should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Office Of The Center Director, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 5100, Rockville, MD 20852, Telephone (800) 332-1088.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Prior to administering skin tests, the skin should be cleaned with alcohol and allowed to dry completely. The tests should be placed on the volar surface of the forearm and four rows may be placed on the back. INTRADERMAL TEST The intradermal test is performed by administering 0.1 mL of extract into the skin. The injection should be given as superficially as possible creating a distinct bleb approximately 5 mm in diameter. The tests should be examined after 15 - 20 minutes and read as negative or positive. Test sites that show a wheal and flare response should be measured and reported in mm of edema and erythema or scored as 1+ to 4+ based on a mm reference scale. Induration after 24 - 48 hours can occur in some individuals and also may be recorded in mm.

More information

Category Value
Authorisation number BLA102211
Agency product number 199I7J3JIV
Orphan designation No
Product NDC 49643-128
Date Last Revised 13-05-2009
Type HUMAN PRESCRIPTION DRUG
Storage and handling STORAGE Extract should be stored at 2°C to 8°C, since higher temperatures may adversely affect the stability of allergens. Do not freeze.
Marketing authorisation holder Allermed Laboratories, Inc.
Warnings WARNINGS This product is intended for use by physicians who are experienced in the administration of allergenic extracts or for use under the guidance of an allergy specialist. Skin tests should be performed after the patient's physical well being and allergic history have been evaluated. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur, and in certain individuals these reactions may cause death. Patients should be observed for at least 20 minutes after skin tests have been completed. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction. This product should never be injected intravenously (see DOSAGE AND ADMINISTRATION). Also, see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections below.